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Ketamine-like depression treatment on track for FDA approval

 

Ketamine offers lifeline for people with severe depression, suicidal thoughtsThe drug is a close relative of ketamine, a powerful medication used in hospitals primarily as an anesthetic; recent scientific studies have also shown its potential with treatment-resistant depression and suicidal ideation. Ketamine is also used recreationally — and illegally — as a club drug known as Special K. It generates an intense high and dissociative effects.Esketamine, which is not FDA-approved for any conditions, targets a different brain pathway than approved antidepressants, many of which have been around for decades. It is expected to be used in combination with antidepressants, but the latter can take a month or two to take effect. Esketamine, on the other hand, might have an effect within hours or days, according to an FDA briefing document.The drug was designated as a breakthrough therapy in 2013, intending to “expedite the development and review of drugs for serious or life-threatening conditions,” the FDA says. First-line treatments don’t work for roughly 30% to 40% of patients with major depressive disorder, according to the briefing document.The FDA does not have to follow the recommendation of advisory committees, though it often does.

ERs 'flooded' with mentally ill patients with no place else to turn

ERs ‘flooded’ with mentally ill patients with no place else to turnHowever, the research behind esketamine has come under some criticism, with two of five key studies failing to meet their primary endpoints. Only one of these studies is a positive short-term trial, whereas most FDA-approved antidepressants are backed by at least two, according to the briefing document. But Janssen has maintained that the overall picture is positive.Adverse events tended to occur in the first two hours patients received the drug, including sedation, blood pressure increases and dissociation. For this reason, patients wouldn’t be able to pick it up at a local pharmacy; it would be given under the supervision of health care professionals who can keep an eye on the person during those first two hours.Because of the drug’s close relationship to ketamine, experts have also raised concerns about its potential for misuse and abuse. The clinical trials have not seen evidence of this risk, according to presentations made during the meeting.Advisory panelists also expressed concern that not enough long-term data was available to characterize the drug’s cognitive effects and other health impacts down the line.Get CNN Health’s weekly newsletter

There were six deaths of patients taking esketamine in trials, including three suicides, but FDA materials concluded “it is difficult to consider these deaths as drug-related.”The only current FDA-approved medication for treatment-resistant depression combines two other drugs already on the market. Other non-pharmaceutical treatments exist, such as electroconvulsive therapy.Janssen spokesman Greg Panico said no information about pricing would be available at this time. An FDA decision is expected in early March, he added.

 

CNN)A ketamine-like drug for treatment-resistant depression was backed by a US Food and Drug Administration advisory committee on Tuesday. If it is then approved by the FDA, the drug — called esketamine — may provide a new option for patients with major depressive disorder who have tried at least two other antidepressants without success.A panel of experts voted to endorse the drug, which is made in nasal spray form by the pharmaceutical company Janssen, a division of Johnson & Johnson. Fourteen members voted that the benefits outweighed the risk, with two opposed and one abstaining.

Ketamine offers lifeline for people with severe depression, suicidal thoughts
703-844-0184 | NOVA Health Recovery | Alexandria, Va 22306

Ketamine offers lifeline for people with severe depression, suicidal thoughtsThe drug is a close relative of ketamine, a powerful medication used in hospitals primarily as an anesthetic; recent scientific studies have also shown its potential with treatment-resistant depression and suicidal ideation. Ketamine is also used recreationally — and illegally — as a club drug known as Special K. It generates an intense high and dissociative effects.Esketamine, which is not FDA-approved for any conditions, targets a different brain pathway than approved antidepressants, many of which have been around for decades. It is expected to be used in combination with antidepressants, but the latter can take a month or two to take effect. Esketamine, on the other hand, might have an effect within hours or days, according to an FDA briefing document.The drug was designated as a breakthrough therapy in 2013, intending to “expedite the development and review of drugs for serious or life-threatening conditions,” the FDA says. First-line treatments don’t work for roughly 30% to 40% of patients with major depressive disorder, according to the briefing document.The FDA does not have to follow the recommendation of advisory committees, though it often does.

ERs 'flooded' with mentally ill patients with no place else to turn

ERs ‘flooded’ with mentally ill patients with no place else to turnHowever, the research behind esketamine has come under some criticism, with two of five key studies failing to meet their primary endpoints. Only one of these studies is a positive short-term trial, whereas most FDA-approved antidepressants are backed by at least two, according to the briefing document. But Janssen has maintained that the overall picture is positive.Adverse events tended to occur in the first two hours patients received the drug, including sedation, blood pressure increases and dissociation. For this reason, patients wouldn’t be able to pick it up at a local pharmacy; it would be given under the supervision of health care professionals who can keep an eye on the person during those first two hours.Because of the drug’s close relationship to ketamine, experts have also raised concerns about its potential for misuse and abuse. The clinical trials have not seen evidence of this risk, according to presentations made during the meeting.Advisory panelists also expressed concern that not enough long-term data was available to characterize the drug’s cognitive effects and other health impacts down the line.Get CNN Health’s weekly newsletter

There were six deaths of patients taking esketamine in trials, including three suicides, but FDA materials concluded “it is difficult to consider these deaths as drug-related.”The only current FDA-approved medication for treatment-resistant depression combines two other drugs already on the market. Other non-pharmaceutical treatments exist, such as electroconvulsive therapy.Janssen spokesman Greg Panico said no information about pricing would be available at this time. An FDA decision is expected in early March, he added.

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Depression Therapy With Party-Drug Roots Faces FDA Panel Review

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Potential for abuse and strategies for containing any risks from an experimental depression treatment from Johnson & Johnson will be in focus at an Food and Drug Administration panel next week.

J&J’s nasal spray, esketamine, a close cousin of the party drug ketamine, will be considered by an FDA advisory panel on Feb. 12. While agency staff seemed satisfied that the likelihood of abuse is low, they raised questions about safety issues connected to a dreamlike sensation the medication can create in some users.

“Ketamine abuse is relatively uncommon in the general population,” agency staff said in a report ahead of next week’s meeting. Just 1.3 percent of people over age 12 abuse the drug, lower than abuse rates for other hallucinogens like ecstasy and LSD.

At the same time, reviewers worried that patients could get into accidents or otherwise be harmed if they leave a doctor’s office while still experiencing disassociation, a known side effect of ketamine — and a sought-after experience for casual users who have dubbed the spacey feeling the “K-hole.”

It takes roughly 90 minutes for disassociation symptoms from esketamine to resolve, according to the report. FDA staff also cited elevated blood pressure as a safety concern.

Esketamine is a key part of J&J’s pharmaceutical pipeline, as the company faces flagging sales this year weighed down by drug pricing scrutiny and looming generic competition. Its shares, which rose 2.3 percent this year through Thursday’s close, were were little changed in early trading on Friday.

In addition to weighing in on the drug’s safety and a proposed risk-evaluation and mitigation strategy, FDA staff will ask advisers to vote on whether esketamine effectively treated the depression of patients who weren’t helped by other therapies. They’ll also discuss whether additional studies are needed before or after the drug is potentially approved.

The staff report noted there were six deaths among patients taking the J&J drug, of which three were suicide in the esketamine depression program, but they didn’t see a clear link to the drug itself.

“Given the small number of cases, the severity of the patients’ underlying illness, and the lack of a consistent pattern among these cases, it is difficult to consider these deaths as drug related,” staff reviewers noted.

A decision on whether to allow the drug on the market is expected by March 4. Esketamine has the FDA’s breakthrough-therapy designation in treatment-resistant depression as well as for depressed people at risk of suicide. Results from a study in suicidal patients are expected this year. Allergan is also testing a fast-acting antidepressant, rapastinel, which is about a year behind esketamine in testing.

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CBD Gummies for Anxiety and Depression :
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CBD become one of the most sought-after medicines on the market today. Not only is it able to treat a wide range of ailments ranging from cancer to arthritis, CBD is known to be effective without causing any obvious side effects. It can be used safely in the long-term without causing addiction and dependence.

NOVA Heath Recovery Ketamine Treatment Center | Call 703–844-0184 for a Ketamine Treatment | Alexandria, Va 22306 | 7 days a week and evening appointments as well! We also evaluate depression, ADHD, PTSD. Intranasal Ketamine available.   The email is EMAIL@novahealthrecovery.com

There are tons of ways to use CBD, and one of the most popular is to use CBD gummies. These products provide patients with a tasty and fun way to medicate themselves. In this article, we’re going to talk about the use of CBD gummies for helping to fight off anxiety and depression.

What is CBD?

CBD, also known as cannabidiol, is one of the main cannabinoids found in the cannabis and hemp plants. CBD is known to treat a number of illnesses, both mental and physical. Some of the things that CBD is most commonly used to treat include:

  • Arthritis and other inflammatory conditions
  • Anxiety, depression, and other mental health problems
  • Cancer
  • Various diseases of the intestinal tract like IBS and Crohn’s disease
  • Various forms of pain, both chronic and acute

These are just a few of the things that CBD can be useful for treating. CBD works by affecting the body’s endocannabinoid system, a system of neurotransmitters that affects a huge number of our bodily processes. We’ll touch on that later in the neurochemistry section.

CBD is attractive to a number of people because it presents a holistic alternative to a lot of pharmaceutical medications. Many people find that their pharmaceuticals may be effective for treating a problem on the surface, but the side effects often compete with the benefits and in the long-run the illness is rarely treated.

CBD gummies, on the other hand, can help people manage the symptoms of their illnesses without actually becoming dependent on a drug or overwhelmed by side effects. This provides a unique opportunity to actually heal the root of the problem.

CBD vs THC

Many people are hesitant to use CBD because they know that it comes from the same plant as THC. THC, or tetrahydrocannabinol, is another cannabinoid. This one is largely responsible for many of the psychoactive effects that a person can experience when smoking marijuana.

Marijuana is quite a powerful drug and it’s understandable that some people would want to ensure that they’re not going to get high when using CBD. Rest assured, CBD and THC have vastly different effects, and CBD is not psychoactive at all.

This is interesting because structurally, CBD and THC are almost identical. Their molecules have the same number and same type of atoms; they are simply arranged differently. This contributes to the vast differences in experiences when using these two compounds.

CBD Effects

The interesting thing about CBD is that it will not have many effects if you are not treating an actual problem. That is to say, CBD works by helping to restore balance and function to the endocannabinoid system (ECS), as mentioned earlier. If your endocannabinoid system is in perfect health, then taking CBD won’t do much for you.

Unfortunately, the reality is that most of us have at least some imbalance in our ECS. These imbalances can come from a number of things that we’re exposed to on a daily basis: pollution, stress, unhealthy food, etc.

For these people, CBD is known for providing a number of positive benefits:

  • Reduced inflammation, improving pain and swelling for people with problems like arthritis
  • Increased relaxation and ability to fall asleep
  • Reduced anxiety and depression
  • Improved sociability
  • Improved concentration
  • Improved digestion

All of these benefits can work together to help ward off various illnesses and diseases.

Does CBD Get You High?

CBD does not get you high. As mentioned earlier, the CBD molecule is nearly identical to the THC molecule. However, because of the arrangement of these molecules, the two compounds act entirely different inside the body.

THC directly affects the body whereas CBD indirectly affects the body. This is why THC is much more apparent when ingested than CBD.

CBD Gummies

CBD Products

There are a huge number of different products containing CBD available. The variety in products allows for patients to choose from a number of ways of consuming CBD. The different methods of taking CBD will provide differences in the effects and duration of the substance.

  • CBD oil and tinctures are among the most popular CBD products. These oils and tinctures are so popular that we have dedicated a section to them below.
  • CBD capsules. Capsules are great for oral use but they can also be broken apart and taken sublingually or under-the-tongue. Capsules tend to come on slower than the other methods of using CBD but they also last for a bit longer.
  • Smokeables and vape products are useful for people who have acute problems like pain or panic attacks. These products can be inhaled and the effects felt almost immediately, though they tend to wear off much quicker.
  • Topical products. There are a number of products made with CBD that can be applied directly to the skin. These products are great because the active ingredient can be absorbed into the skin and there won’t be any effects on a person’s mental or physical site except where they apply it.

CBD Oil

CBD oil is one of the most popular forms of using CBD. This is because the oil provides you with a concentrated form of the active extract that can be consumed in a number of ways

The most effective way to use CBD oil is to take it sublingually. This involves holding the oil under your tongue for about 5 minutes so the CBD can be absorbed into the blood vessels there. This causes it to hit you faster and you’ll end up using less of it this way, thus saving money.

CBD oil is also used in the making of a number of other CBD products, like edibles.

CBD Edibles

CBD edibles are one of the most popular ways to consume CBD. People have had great success using CBD oil to make snacks and treats filled with CBD that people can eat. Ranging from CBD gummies to CBD peanut butter, edibles are a great way to medicate yourself.

One of the best things about edibles is that they are more slowly metabolized than the other forms of CBD. This means that the active effects may come on a bit slower but they will linger for much longer.

CBD and Anxiety

One of the most popular uses for CBD gummies and other forms of CBD is for helping people manage anxiety.

Many people were baffled by the implications of this, particularly because THC is well-known for causing anxiety in many people. Folks were wondering how a cannabinoid – especially one so similar to THC – could be used for fighting anxiety.

We’ll discuss the reasoning a bit more in the neurochemistry section below. For now, the simple fact of the matter is that CBD helps to manage anxiety by relaxing the mind and body, as well as balancing out the endocannabinoid system.

CBD has been shown to be useful for fighting all sorts of anxiety, ranging from generalized anxiety to panic disorder. Many have found success using a vape pen to help them manage acute panic attacks. CBD has even been shown to help fight anxiety associated with serious conditions like post-traumatic stress disorder.

CBD and Depression

CBD has proven to be a very exciting alternative for helping people manage depression.

Many traditional antidepressants are known for causing a huge number of side effects. These drugs often take a long time to work – many people have to use them for up to three weeks before these drugs work – and they often have drastic effects on a person’s physical and mental health.

CBD might not be as potent as some of these antidepressants, but it targets the problem in a much more holistic manner. Instead of blunting your emotions or inhibiting your ability to feel depressed by overloading your brain with neurotransmitters, CBD helps you overcome acute symptoms of depression so you’re actually able to identify and heal the root of the problem.

CBD gummies and other forms of CBD are a great tool for helping some people get the treatment that they need to actually eliminate their depression. After this, they can stop using CBD. This is in stark contrast to traditional antidepressants which many people find themselves using for the rest of their lives.

Neurochemistry and CBD

We have touched on the subject of CBD and neurochemistry in this article, but only briefly. In this section we will give a bit more information about the way CBD affects our brain and nervous system.

As mentioned, CBD affects the ECS. This massive system of neurotransmitters and receptors is responsible for governing many facets of our brains and bodies. It helps to regulate our immune system, manage our digestion, regulate our mental health, and generally help to ensure that we function properly.

Unfortunately, many of us have an imbalance in the ECS. CBD works by helping to restore balance to this vast system by indirectly influencing it.

This is one of the reasons that CBD has such vastly different effects than THC. THC directly binds to what are known as cannabinoid receptors. By binding to these receptors, THC can have a direct, immediate, and profound effect on this entire system.

CBD, on the other hand, works indirectly. Not only does it not bind to the receptors, but it actually makes it more difficult for substances like THC to bind to them. Instead, CBD works ‘behind the scenes’ to have a positive and regulatory effect on certain neurotransmitters like dopamine, serotonin, and our own naturally produced cannabinoids.

CBD Dosage

The dosage that one requires when they are using CBD depends on their condition and how serious it is. Dosages vary greatly between people and since CBD hasn’t been approved by federal organizations there is no standard dosage.

However, there are certainly some standards that one could expect to use.

  • People with anxiety may need anywhere from 10 to 50 mg of CBD. 10 mg doses of capsules or oils can be useful for helping to treat mild-to-moderate social anxiety and general anxiety. Higher doses can stave off a panic attack in its tracks.
  • People with pain or inflammation often require slightly higher doses. 20 mg can be effective for mild-to-moderate inflammation, but doses of anywhere from 50-100 mg are quite common.
  • People with depression often take higher doses, beginning at around 50 mg. However, people with melancholy or mild depression caused by situations or events can find some improvement using around 20 mg.

Keep in mind the way that you consume your CBD also has an impact on how much you need. Consuming CBD gummies or tinctures orally causes some of the drug to be destroyed by the liver before it’s absorbed into the bloodstream. Taking it sublingually helps to prevent this and reduces the amount required by about 40 percent.

CBD Side Effects

The vast majority of people won’t experience any side effects from CBD. Aside from the fact that higher doses might make you sleepy and unfit to drive a motor vehicle, CBD won’t cause any serious side effects unless you are allergic to cannabinoids.

That said, some people are extremely sensitive to the compound. These people may experience symptoms like dry mouth, diarrhea, and nausea. However, this may indicate that the medicine was not prepared properly or was produced in a facility with low safety and health standards.

One thing to be noted is that people using THC for recreational purposes might find the effects diminished if they use CBD. However, people who are using THC for medicinal purposes often find that the benefits are enhanced when they are using CBD in addition to THC.

Hopefully, this article has helped you to better understand CBD and the powerful benefits that it can provide for you and those that you love. Good luck healing yourself with this fantastic medicine.

What is Depression?

Depression is a mental health disorder associated with significant morbidity and mortality, being a major risk factor for suicide, substance abuse, poor outcomes of medical conditions, and impaired functionality. It is characterized by flattening of mood, loss of emotional expression, and retardation of thought and movements. Individuals who have depression usually have a depressed mood, loss of interest in activities they were usually interested in, sleep disturbance, loss of energy, and reduced ability to thick or focus.

The American Psychiatric Association’s Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) categorizes depressive disorders into major depressive disorder, persistent depressive disorder, premenstrual dysphoric disorder, disruptive mood dysregulation disorder, and depressive disorder due to a medical condition. However, all these classes of depression are characterized by the presence of a sad or irritable mood with associated difficulty in thinking, concentrating, and carrying out normal physical tasks, impairing the individual’s daily functioning.

Stats about Depression

Between 2009 and 2012, approximately 7.6% of Americans aged 12 and above were diagnosed with depression and it was more common among females and persons aged 40 and 59. In 2015, about 16.1 million adults aged 18 and over had a minimum of one depressive episode in the previous year.

Depression has been found to occur in children at an incidence rate of 0.9% in preschool-aged children, 1.9% in school-aged children, and approximately 4.7% in adolescents. In prepubertal children, depression occurs in boys and girls at an equal rate. Generally, depression in men and women has the highest rates in those aged between 25 to 44 years and the incidence of severe depression increases with age.

What are the Traditional Treatments for Depression?

There is a wide range of treatments for depression which have proven effective in improving symptoms. A combination of medications and psychotherapy is effective in reducing the symptoms of depression, and therapy with either form alone is often ineffective. Combination therapy has been found to increase quality of life and improve treatment compliance in patients with depression.

Advanced treatment techniques used for the treatment of depression include electroconvulsive therapy which uses high-energy electric stimulation, and bright-light therapy involving exposure of an individual with depression to bright light at an intensity of 10,000 lux for a period of one hour in the morning.

Therapy for Depression

Psychotherapy is often combined with medications in the treatment of depression. There are different types of therapy for depression and these can be grouped based on their efficacies. A therapy is considered “efficacious and specific” if studies in at least two settings (hospital, home therapy, rehab center etc.) have proven it more effective than medications. A therapy is considered “efficacious” if it has been proven from at least two settings that it is superior to no treatment at all, and it is “possibly efficacious” if it has been proven effective in at least one study in a single setting.

Examples of efficacious and specific therapies include cognitive behavioral therapy, problem-solving therapy, and interpersonal therapy which help the individual modify their behaviors and interpersonal relationships. An example of an efficacious therapy includes mindfulness-based cognitive therapy to prevent a recurrence or relapse, and an example of possibly efficacious therapy is continuation cognitive therapy to prevent recurrence by helping the individual develop positive thinking and behavioral patterns.

Medications for Depression

Medications used for treating depression are of different classes, each with a different mechanism of action, characteristics, and side effects. Some of these drugs include Fluoxetine (Prozac), Citalopram, Amitriptyline, Imipramine, and Nortriptyline. These drugs generally increase the concentration of stimulant substances in the brain to improve the depressive symptoms.

Home Remedies for Depression

Patients with depression could benefit from a number of home remedies which could help to improve their symptoms, in addition to antidepressants and therapy:

  • St. John’s wort – This plant, although not approved for treatment of depression by the FDA, has been linked with increased amounts of serotonin in the body correlating to improvement of depressive symptoms.
  • Omega-3 fatty acids – Omega-3 fatty acids are commonly found in fish such as salmon, sardines, and trout, and this substance has been linked to improvement in depressive symptoms.
  • SAM-e – S-adenosylmethionine (SAM-e) is artificially designed to function like chemicals in the brain which elevate mood. It is considered a supplement useful in improving symptoms of depression.
  • Folate – Folic acid which is found in a number of foods such as beans, lentils, dark leafy greens, and fortified cereals have been found to improve the effectiveness of medications used in treating the disorder.

What is CBD?

Cannabidiol (CBD) is a naturally occurring chemical compound found in the hemp plant. It is one of the numerous unique compounds called cannabinoids which naturally occur in hemp. Generally, cannabinoids can be produced in the body (these are known as endocannabinoids) or found in the hemp plant as phytocannabinoids. CBD is industrially extracted from the cannabis plant and separated from the other cannabinoids, representing about 40% of cannabis extracts.

CBD is a phytocannabinoid which helps to stimulate the regulation of the central nervous system. CBD, therefore, helps supplement the effects of endocannabinoids in regulating appetite, mood, functions of the immune system, sensation, and keeping our bodies working normally. CBD oil is made from hemp plants and can be purchased legally in the United States. CBD is available in different forms such as tinctures, concentrates, capsules, sprays, tapes, and topicals.

CBD vs. THC

Most times, people interchange CBD for tetrahydrocannabinol (THC), another cannabinoid found in the hemp plant. Both of them represent the commonest compounds found in the plant. However, they have numerous differences.

THC, unlike CBD, is intoxicating causing a high and euphoria. It is responsible for the “high” felt by marijuana users. CBD, on the other hand, is not a psychoactive substance as it does not act via the same biological pathways in the body as THC.

CBD Oil Effects

Although, CBD oil has not been approved by the FDA for the treatment of any condition, there have been several studies demonstrating some of its health benefits:

  • CBD has been shown to have anti-oxidant properties which means that it is capable of mopping up toxic substances obtained from food or generated in the body. These substances are often at the center of inflammatory conditions such as myocardial infarction, inflammatory bowel disease, and stroke.
  • Oxidative stress caused by the release of these toxic substances causes age-related diseases such as Alzheimer’s disease and Parkinson’s disease and CBD has been found to protect against these degenerative diseases of the brain and reduce their clinical progression in patients suffering from them. CBD may also help in the clinical improvement of some autoimmune disease such as lupus and rheumatoid arthritis.
  • Clinical trials have shown that CBD oils are effective in the treatment of epilepsy and other seizure disorders.
  • Studies have shown that CBD may have therapeutic benefits for brain disorders such as psychosis, depression, and multiple sclerosis.
  • Other benefits of CBD are currently being investigated, including its effects on anxiety and depression, as well as on social anxiety disorder and post-traumatic stress disorder.

Does CBD Get You High?

CBD is a non-psychoactive form of cannabinoid which has been found not to interfere with the cognitive functions of the brain. It does not get you “high,” in contrast to THC, which alters the cognitive functions of the brain.

Is CBD Addictive?

According to a recent report by the World Health Organization (WHO), CBD is not addictive and it has no potential for abuse or dependence. This is mainly because CBD does not contain any addictive substances, in contrast to THC and some cannabinoids which contain such and are, therefore, capable of being addictive.

Is CBD Safe?

There have been extensive reviews on the toxic potentials of CBD and reports have revealed that CBD has a relatively low toxicity. It has been found to be safe with little potential for adverse effects. CBD was found to have no effect on fetal development and other bodily functions. Generally, CBD does not produce the adverse effects seen with THC and other psychoactive cannabinoids. However, reports demonstrate that some reactions may occur as a result of its interactions with other drugs co-administered with it.

How Could CBD Help with Depression?

CBD has been found to be effective in the treatment of depression. While CBD does not cure the condition, it has been linked to improvement of the symptoms.

The cannabinoids produced in our bodies (endocannabinoids) help to regulate several functions of the body such as mood, pain sensation, sleep, and appetite. These substances exert their actions by binding to specific points of brain cells called the receptors through which they potentiate the actions of a substance called serotonin which acts to improve mood and reduce stress levels. Serotonin also acts by binding to its receptors in brain cells. When these chemical substances bind to their respective receptors, they trigger a series of events within each brain cell stimulating processes that improve mood and stress control.

CBD has been found to help improve depressive symptoms by modulating the actions of the endocannabinoids and also potentiating the effects of serotonin by enhancing the activity of the receptors unto which serotonin binds.

CBD oil helps to significantly improve depressive symptoms and the individual’s quality of life.

CBD Oil Dosage

CBD oil is available in several forms including tinctures, capsules, concentrates, and topical forms. However, it is most commonly administered orally. It is important to note that CBD is most effective when used regularly in maintenance doses, though it may be used for treating acute flare-ups.

In the management of depression, CBD oil may be taken in the tincture and capsule forms. Individuals with depression can begin with a dose of 5 to 10mg daily until the desired results are achieved. Gel capsules of CBD are available as 25mg per pill and it is safe to begin at this dosage as CBD has a good safety profile. The effects of CBD lasts several hours after a dose is ingested and most persons report feeling better for up to 24 hours. However, you will only begin to notice these improvements after 90 minutes of ingestion of CBD oil.

For managing acute flare-ups, it is best to vaporize CBD isolate for fast relief of symptoms. However, the maintenance dose should not be discontinued. Although you may also use the ingestible forms of CBD in treating acute flare-ups, these, generally, have a relatively longer onset of action.

Generally, it is recommended that you consult with your physician before starting CBD oils to prevent drug interactions and exacerbations of any medical conditions you may have. Do not, also, discontinue or start any drug while using CBD without consulting your physician.

For information on where to obtain CBD Oil, go here.

CBD Oil Side Effects

CBD oil is generally safe to use with minimal risk of adverse effects. Side effects may be seen when high doses are taken. Some studies have revealed that if taken at high doses, it may cause a weakening of your immune system. However, the main concern with the use of CBD is the risk of drug interactions, therefore, it is recommended that you consult your physician before using CBD oil.

Bottom Line: Can CBD Help You?

CBD is one of the naturally occurring chemical substances found in the cannabis plant and though the stigma associated with the psychoactive counterpart, THC, has rubbed off on it, it has been shown to have immense health benefits in treating conditions such as anxiety, depression, mood disorders, and inflammatory diseases. CBD oil helps to significantly improve depressive symptoms and the individual’s quality of life. However, it should be noted that CBD does not provide a cure for the disorder, but leads to a better quality of life for the patient.

Resources

https://emedicine.medscape.com/article/286759-overview#a4

https://www.webmd.com/depression/features/natural-treatments#1

https://www.healthline.com/health/depression/herbs-supplements

https://ministryofhemp.com/wp-content/uploads/2016/10/The-Complete-CBD-Resource.pdf

https://www.royalqueenseeds.com/blog-new-who-report-shows-cbd-is-not-addictive-nor-dangerous-n771

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3648779/

https://keytocannabis.com/blogs/cannabis/cbd-for-depression

https://www.ncbi.nlm.nih.gov/pubmed/24923339

https://www.ncbi.nlm.nih.gov/pubmed/22729452

https://www.ncbi.nlm.nih.gov/pubmed/20002102

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Ketamine for Depression: Does it work?

What is Ketamine?

Ketamine, also known as Ketalar, Ketaset, and Ketanest, is a medication that’s currently FDA approved only as an anesthetic but it’s showing great potential as a treatment for severe depression. In fact, numerous Ketamine Clinics have begun to appear throughout the United States to solve this problem. Depressed patients with stubborn symptoms get relief within hours rather than weeks with conventional anti-depressants. Doctors can only prescribe ketamine for depression off-label because studies are relatively new, but experts are saying that ketamine is one of the biggest breakthroughs in severe depression treatment to come along in decades [1].

Ketamine is a powerful pain reliever and a relaxant, but at higher doses it can also induce unconsciousness and disturbances in how a person experiences sight and sound. In high doses, it can produce hallucinations and delusions and its ability to create strong dissociative experiences have made it popular in the club scene where it’s known as “Special K”. An overdose of ketamine can be fatal and it can be addictive if patients don’t follow their doctor’s prescription guidelines. Currently, ketamine is scheduled as a class III drug and it’s created a lot of controversy among experts who disagree about whether it’s safe for doctors to prescribe it as a treatment for chronic depression. Despite the intrigue and the need for additional research to establish its safety and efficacy, ketamine clinics are now offering infusion treatments to patients all over the United States [1][2][8][9].

Effects of Ketamine

As a street drug, ketamine creates a sense of dissociation and can change a person’s sense of hearing and sight, but for patients with severe depression, ketamine relieves mood problems within hours or sometimes moments for about 85% of those treated. While conventional anti-depressants can take several weeks to take effect, studies have shown that ketamine often improves depression symptoms almost immediately. Patients typically feel better within hours [1][2].

Doctors, dentists, and psychiatrists prescribe ketamine to help their patients achieve a variety of different health goals. Doctors often use ketamine in FDA approved situations such as procedures involving cardiac catheterization, orthopedics, skin grafting, or diagnostics involving the eye, ear, nose, and throat. Surgical dentists may also use ketamine as an anesthesia during tooth extractions. After other treatment options have been attempted and failed, doctors may use ketamine to treat certain types of seizures in patients with status epilepticus [2].

Researchers demonstrated in 2014 that ketamine reduced symptoms of post-traumatic stress disorder in 41 patients and there are other exciting possibilities on the horizon in terms of PTSD treatment. Treatment-resistant depression and substance use disorders could both be treated with this drug, though many medical professionals view ketamine treatment for these mental health issues as controversial [2].

Ketamine for Pain Management (CRPS)

Central Sensitization is a process the central nervous system goes through which causes Complex Regional Pain Syndrome (CRPS/RSD) and other types of chronic pain. In central sensitization the number of NMDA receptors increases which amplifies a patients’ experience of pain. Ketamine interferes with NMDA receptors which puts a damper on pain signaling, providing pain relief and a desensitization to pain for patients affected by CRPS [8].

At low doses, ketamine can relieve chronic pain and potentiate the effects of sedatives. Researchers believe that ketamine could provide an alternative to more addictive painkillers like morphine if the FDA approves it for this use [1][8].

Ketamine for Anesthesia

In the 1960’s doctors used ketamine as an anesthetic on the battlefields in Vietnam because administration lends itself well to use in disaster zones; doctors don’t need electricity, an oxygen supply, or even highly trained staff to give patients ketamine. Since that time, the FDA has only approved ketamine for use as an anesthetic in hospitals and medical settings. As an anesthetic, ketamine doesn’t lower the patient’s breathing rate or blood pressure, which makes it safer than other anesthesia options. It’s for this reason that veterinarians use ketamine more than any other type of anesthetic for surgery on animals [1][2].

Ketamine for Depression

Depression is a major issue in the United States and though there are many anti-depressants on the market, about one-third of patients don’t experience any relief from their symptoms using the drugs that are currently available. Ketamine acts on depression by rebalancing a different set of neurotransmitters and receptors (the NMDA/glutamate receptors and GABA receptors) than the old-school Selective Serotonin Reuptake Inhibitors (which function by blocking reabsorption of serotonin). By blocking glutamate receptors in the brain, the majority of patients with ‘Treatment Resistant Depression’ are able to experience relief from their symptoms using ketamine [1].

Even though ketamine has yet to be approved by the FDA for use in treating depression, patients are flocking to ketamine clinics to receive the treatment off-label. It provides fast relief, which is vitally important in cases where patients feel suicidal and for depressed patients who have tried all of the other anti-depressants available with no luck, ketamine offers new hope. Infusion treatments take about 1 hour at a clinic, but the results are long-lasting with most patients returning only once every one to two weeks over a specified period of time. The treatment is expensive, but the results are promising enough that patients are willing to pay out-of-pocket for it [5][8][9].

The FDA hasn’t yet approved ketamine for use as an anti-depressant, but both Esketamine and Rapastinel (developed by Johnson & Johnson and Allergan respectively) have been fast-tracked as breakthrough drugs. The demand for these two medications is projected to grow rapidly in the coming years.  Still, doctors can only prescribe ketamine for depression off-label since ketamine has been FDA approved for use as an anesthetic, not as an anti-depressant. Researchers have cautioned doctors to avoid over-prescribing this drug because the long-term health and well-being of patients could be at risk. Ketamine has a high potential for abuse, after all and experts claim that the evidence does not exist to prove that this drug is safe [1][2][6].

Ketamine as Drugs of Abuse

Ketamine is abused as a recreational drug and it has effects that are similar to Phenylcyclidine (PCP), LSD, dextromethorphan (DXM) and nitrous oxide (laughing gas). Ketamine is a dissociative anesthetic that can alter one’s sense of sight and sound and also produce profound relaxation, hallucinations, and delusions for about an hour. The effects of the drug come on almost immediately. It has been used as a rape drug that can render women unable to speak or to move [1][2].

People who abuse ketamine have developed serious bladder and kidney problems such as ulcerative cystitis, stomach issues, and memory loss. In fact, street users even risk developing depression as a result of addiction and dependence on the drug [2].

How is Ketamine used for depression?

Doctors may prescribe ketamine by itself or in tandem with other anti-depressants [3]. Many experts on depression recommend that ketamine only be used as a short-term depression treatment option while other anti-depressants are taking effect. Though there are convenient ketamine nasal sprays in research and development by Johnson & Johnson, the high-potential for abuse of this drug has made many doctors and psychiatrists wary of using this drug to treat depression long-term. Further, some medical organizations are concerned that the long-term effects of chronic ketamine use is not well-understood. According to these organizations, more research is needed to establish the safety of this drug [1][2][6].

Promising Remedy for ‘Treatment Resistant Depressions’

Thomas Insel, the director of the National Institute of Mental Health says, “Recent data suggest that ketamine, given intravenously might be the most important breakthrough anti-depressant in decades.” Conventional anti-depressants aren’t able to help about one-third of patients with major depression, but new ketamine drugs such as esketamine (in development by Johnson and Johnson) may offer new hope. Infusion therapies available through ketamine clinics across the United States report a high success rate of 60% to 70% treating Treatment Resistant Depression as well as Major Depression with risk of suicide [1][3][5][6].

Fast-Tracked by FDA

Two drugs, Johnson & Johnson’s Esketamine and Allergan’s Rapastinel, were both upgraded to ‘fast-track’ status by the FDA in 2016 due to their importance and promise in treating treatment resistant depression.

Depression is the leading cause of disability in the world and currently, 12% of Americans (about 29 million people) are taking anti-depressant medications. The suicide rate is higher now than it has been in over 30 years. And about one-third of depressed Americans don’t experience relief taking conventional anti-depressants. In the interest of capitalizing on the market value of depression, which is projected to almost double by the year 2024, the FDA will review the use of these new ketamine-based depression drugs in 2018 and 2019, allowing Johnson & Johnson and Allergan to go through an abbreviated version of the normally lengthy FDA approval process for new drug therapies [5][6].

Experimental Trials

Drug trials have shown that 60% to 70% of patients with Treatment-Resistant Depression have been responsive to ketamine. Esketamine, a nasal spray developed by Johnson & Johnson, is in Phase III clinical trials right now. They are expected to receive FDA approval later in 2018, and once that happens, it will open doors for administering ketamine outside a clinic setting.

Rapastinel, which was developed by Allergan, is out of Phase III and awaiting FDA approval. The drug can be administered within 30 seconds intravenously and Allergan is working to develop an oral version of the drug as well [2][3][5].

How Ketamine Therapy Works

Ketamine therapy is usually performed at a ketamine clinic. Patients receive an intravenous infusion of the drug with relief from depression symptoms that can last for several weeks.

Ketamine Infusion or Intravenous Therapy (Infusion Process)

Ketamine can be injected directly into muscle tissue or it can be given intravenously. Researchers for Johnson & Johnson have also recently developed new treatment protocol called Esketamine that’s awaiting FDA approval. Using Esketamine, patients will be able to self-administer the drug as a nasal mist [2][3].

Patients must receive a referral from a doctor to go to a ketamine clinic. There, patients can receive an intravenous infusion of ketamine. On the first visit, a doctor will assess the patient before hooking the patient up to a ketamine IV. Patients then experience a variety of sensations during the infusion and for up to 2 hours following the infusion. Many patients report feeling a sense of deep relaxation and the ability to reflect on past traumas and anxieties calmly [7][9].

How does it work?

Researchers have demonstrated that a deficiency in certain vital connections between certain neurons in the brain may cause depression. Ketamine works as an NMDA receptor antagonist (NMDA is a glutamate receptor also known as N-methyl-d-aspartate) and an AMPA receptor stimulator. As such, ketamine stimulates the development of new receptors and synapses in the brain which helps patients regulate their mood, sleep better, and experience better focus [2][8].

Ketamine works by interfering with and rebalancing the glutamatergic system (glutamate and GABA) to stimulate new synaptic connections, better memory, and brain plasticity [8]. During ketamine infusions, patients may feel capable of exploring traumatic memories more calmly to reframe the past or they may feel a pleasant sensation of relaxation or floating [7]. Effects from an infusion can last for up to a week or two.

Intranasal ketamine formulas work by binding to a receptor called N-methyl-d-aspartate. In the brain, ketamine blocks the neurotransmitter glutamate which causes communication between the conscious mind and other parts of the mind (such as mood centers) to be blocked. In low doses, it relieves depression, but in higher doses, it can cause patients to feel an uncomfortable sense of dissociation from the body similar to a near death experience [2][3][4].

While most anti-depressant medications must build up in the body over the course of several weeks in order to have an effect, ketamine’s mood-altering benefits happen as the drug leaves the body. Researchers don’t know why this is the case, or even exactly how the drug achieves its strong anti-depressant effects but the fact is, ketamine works quickly to relieve depression symptoms in 85% of patients who are resistant to other forms of therapy [1]. Standard anti-depressants target the neurotransmitters serotonin, norepinephrine, and dopamine, but ketamine is different. Ketamine blocks glutamate and stimulates synaptic plasticity or the ability of the brain to change and grow [5].

Doctors don’t fully understand how ketamine works or the potential effects that patients may experience from taking tiny doses of this drug over and over again. What is known is that recreational users can suffer ulcerative cystitis or cognitive issues as a result of prolonged use [5].

Ketamine Infusion Dose/Dosage

Researchers are working to find the perfect ketamine dose for depression patients. The risk of overdosing on this drug is high for the recreational user because there is only a slight difference between a dosage that leads to desirable effects and one that can cause a lethal overdose. The goal for researchers is to find an exact dosage that’s high enough to get rid of symptoms of depression but low enough to prevent patients from experiencing hearing and sight disturbances as well as the other negative effects from the drug [1][2][9]. Ketamine produces only temporary effects on severe depression. Patients must continue to return to the clinic for infusions every few weeks to keep their depression symptoms in check [5].

Ketamine therapy cost? Is ketamine therapy covered by insurance?

Ketamine therapy is rarely covered by insurance and it’s pricey. Patients typically pay between $400 and $800 per infusion in many centers.

Ketamine Infusion Side-Effects

Ketamine use can cause a variety of side effects including:

  • Extreme fatigue or exhaustion
  • Nervousness or restlessness
  • Sweating
  • Amnesia
  • Puffy or swollen eyelids, lips, or tongue
  • Hives, itching, or rash
  • Delusions
  • Difficulty thinking or learning
  • Loss of appetite
  • Nausea
  • Fast heartbeat, slow heartbeat, irregular heartbeat
  • Dizziness, fainting
  • Difficulty swallowing
  • Confusion
  • Convulsions
  • Difficulty breathing
  • Chest pain or discomfort
  • Blurry vision
  • Inability to control eye movement
  • Slurred speech
  • Difficulty urinating, frequent urination, cloudy or bloody urine
  • Paleness, bluish lips, skin, or fingernails
  • Increased pressure in the brain and the eyes [1][2]

Where can you get ketamine therapy? | NOVA Health Recovery Ketamine Treatment Center | Alexandria, Va 22306 | 703-844-0184

Off-label ketamine infusion therapy is an unregulated business that has gotten the attention of both clinicians and medical organizations. There are currently ketamine clinics in a number of cities throughout the United States [10].

s ketamine therapy addictive?

Patients who use ketamine long-term may develop a tolerance and addiction to the drug over time. In medical settings, ketamine is safe to use because the dosage is carefully calibrated and monitored, but there is a high potential for abuse when patients use ketamine recreationally as  a street drug. If patients don’t follow their doctor’s prescription for ketamine it can have extremely negative mental and physical effects particularly on the brain and bladder [2].

Ketamine-Based Drugs in Late Stage Trials

Both Rapastinel and Esketamine are ketamine-based drugs that have been ‘fast-tracked’ by the FDA because the FDA has identified them as “breakthrough drugs” [5].

Rapastinel

Allergan developed Rapastinel, a ketamine drug that can be administered in 30 seconds intravenously. It works on the same receptors as ketamine, but it doesn’t produce hallucinations. An oral version of Rapastinel is also in development. The FDA considers Rapastinel to be a “breakthrough drug” which means that Allergan can speed through the lengthy drug approval process and get the drug to market by 2019 [5].

Esketamine

The FDA has designated Esketamine a “breakthrough therapy”, which means that the drug developers, a subsidiary of Johnson & Johnson, can speed through the lengthy drug approval process to get the drug on the market more quickly. Esketamine can be administered like a nasal decongestant, which would make it more convenient than intravenous therapy for depression patients. Experts feel that Esketemine would be most appropriately used as an adjunct therapy in combination with other anti-depressant medications, not as a standalone treatment for depression [5][6].

According to one recent study, when administered in combination with other oral antidepressants, Esketamine reduced patients’ depression symptoms more than oral anti-depressants alone. The anti-depressant effects of using a conventional anti-depressant in conjunction with Esketamine occurred within only about 1 week. When used alone, Esketamine effects seem to last 1 to 7 days in most patients. Esketamine is in Phase 3 testing with the FDA for use as a drug for ‘Treatment Resistant Depression’ and Major Depression with risk of suicide. Johnson & Johnson will file for FDA approval for this drug as a depression treatment in 2018 [3][6].

Risks of Ketamine Abuse

Ketamine abuse is a serious problem. It is possible to become addicted to ketamine. Patients may begin to need higher doses of the drug in order to experience the positive effects. An overdose of ketamine can be deadly. The effects of using ketamine chronically over a long period of time have not been established, but recreational drug users who have used ketamine long-term have developed ulcerative cystitis as well as cognitive issues [1][2].

The Ketamine Controversy

While ketamine can literally save lives by relieving the symptoms of major, Treatment Resistant Depression, including the risk of suicide, research still has not established the safety of ketamine for long-term use. The lethal dose of ketamine is only slightly higher than the therapeutic dose and its addictive properties mean that it could cause depressed patients more problems than it solves. Ketamine clinics have popped up all over the country to cash in on the high demand for a depression treatment that really works, but the research hasn’t demonstrated that this drug is safe for chronic use. So this is an instance where the buyer needs to beware. The FDA has fast-tracked these drugs because it’s constituents see market potential, but important research still needs to be done on this drug to demonstrate it’s safety and long-term efficacy.

Resources:

[1] Collins, S. (2005-2018). What you need to know about ketamine’s effects. Retrieved April 3, 2018 from https://www.webmd.com/depression/features/what-does-ketamine-do-your-brain#1

[2] Davis, K. (2017). What are the uses of ketamine? Retrieved April 3, 2018 from https://www.medicalnewstoday.com/articles/302663.php

[3] Pagliarulo, N. (2018). J& J builds case for ketamine-based depression drug. Retrieved April 3, 2018 from https://www.biopharmadive.com/news/jj-builds-case-for-ketamine-based-depression-drug/513866/

[4] No Author (2007-2018). Special K and X. Retrieved April 3, 2018 from http://goaskalice.columbia.edu/answered-questions/special-k-and-x

[5] Oaklander, M. (2017). New Hope for Depression. Retrieved April 3, 2018 from http://time.com/4876098/new-hope-for-depression/

[6] Oberhaus, D. (2017). Ketamine Nasal Spray Will Totally Change the Market for Antidepressant Drugs. Retrieved April 3, 2018 from https://tonic.vice.com/en_us/article/wjxd9b/ketamine-nasal-spray-will-totally-change-the-market-for-antidepressant-drugs

[7] Ketamine Advocacy Network (2015). The Infusion Experience. Retrieved April 3, 2018 from http://www.ketamineadvocacynetwork.org/the-infusion-experience/

[8] Ketamine Clinics of Los Angeles (2018). How does ketamine infusion therapy work? Retrieved April 3, 2018 from https://www.ketamineclinics.com/about-ketamine/how-it-works/

[10] Ault, A. (2017). US Ketamine Clinics Continue to Mushroom With No Regulation. Retrieved April 3, 2018 from https://www.medscape.com/viewarticle/886750

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Psychedelic Medicine 101: The curious case of ketamine



Psychedelic Medicine 101: The curious case of ketamine

Vials of Ketamine
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The urban myth of ketamine as a horse tranquilizer became prominent as the drug moved into...

Ketamine is known for generating a profoundly dissociative out-of-body experience
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John Lilly and his infamous isolation tank

John Lilly and his infamous isolation tank

A psychedelic renaissance is underway in medical research as certain taboo drugs return to the hands of doctors and researchers after decades in the wilderness. Once considered illicit, with no medical value, these psychedelic compounds are now being legitimately evaluated by scientists and revolutionizing how we practice medicine.

Psychedelic medicine 101 is a series that will investigate the past, present and future medical uses of these formerly taboo substances. Our first feature examined the story of psilocybin and magic mushrooms, while this new episode documents the curious story of ketamine, initially developed to be an anesthetic before researchers and psychonauts discovered its unique and unusual effects on the brain.

The curious case of ketamine

In 1956, a chemist at pharmaceutical company Parke Davis in Detroit, Michigan was experimenting with synthesizing new compounds in an attempt to find a better anesthetic. A compound called phencyclidine was initially created, and in early animal studies it demonstrated defiantly unusual effects. Some animals exhibited a drunk-like state when administered with it, while others entered states of delirium.

Human tests quickly ruled out the compound as clinically useful with some patients exhibiting major delirious and dissociative states for prolonged periods of time. This was despite the fact the it did seem to function remarkably well as an anesthetic. In later years, phencyclidine hit the streets as a recreational drug, becoming infamous due it its violent side effects. Its street name was PCP, or angel dust.

In the early 1960s, Parke Davis researchers began searching for a phencyclidine derivative that could limit the compounds unmanageable side effects. It was here that ketamine was born and after successful animal tests it was administered to the first human subject in 1964, demonstrating remarkable anesthetic effects.

Initially approved for veterinary uses, ketamine quickly found a place as an effective short-acting anesthetic, officially passed by the FDA in 1970 for human uses. One of its first major human uses was as a battlefield anesthetic in Vietnam. It has been suggested that this initial use in the early 1970s was what led to it moving into recreational circles as veterans returned to the United States and continued using the drug.

Non-medical uses continued throughout the 1970s, culminating in several high profile publications “outing” the drug. Perhaps the most infamous of these accounts came in scientist and psychonaut John C. Lilly’s 1978 autobiography The Scientist: A Novel Autobiography.

John Lilly and his infamous isolation tank

Ketamine, sensory deprivation and alien communication

John C. Lilly is perhaps best known for his work blending LSD, isolation tanks and human-animal communications. After developing the first isolation tank in 1954, Lilly began experimenting with LSD in the tanks in the early 1960s. His extreme work sat at the boundary of conventional science, and the extraordinary 1980 psychedelic film Altered States was significantly inspired by his experiences.

It was the early 1970s, however, when Lilly first crossed paths with ketamine. Lilly had long suffered extreme migraines, almost daily, for much of his life. During an attack, a physician friend suggested ketamine may be helpful. So Lilly jumped into an isolation tank, was injected with a small dose of ketamine, and his migraine disappeared … for 20 minutes. When it roared back his physician friend gave him another injection, this time double the dose. For about half an hour the migraine disappeared, but then it stormed back, so finally the physician again doubled the dose and sent Lilly back into the tank.

After an hour Lilly got out of the tank and his migraine had gone. A month later, with his migraine still yet to return, Lilly became convinced ketamine had somehow reprogrammed his brain in ways that his earlier massive LSD experiences couldn’t. For the next few years Lilly’s personal ketamine experiments became more and more extreme.

Lilly became convinced he could communicate with a network of extraterrestrial entities he dubbed ECCO, or the Earth Coincidence Control Office. ECCO guided Lilly’s research but as he began to consume more and more ketamine he came across another, more malevolent entity called SSI, Solid State Intelligence.

SSI was a massive cosmic supercomputer, with evil intent. At one point, in the midst of an epic nearly month-long physical experiment with ketamine, consisting of injections nearly every hour, Lilly tried to contact President Gerald Ford to warn the world of a potential doomsday scenario. One of the president’s aides intervened before Lilly could reach Ford.

These stories, and others, recounted in the late 1970s, slowly added to the infamy surrounding ketamine, but they also started to pique the attention of the authorities. The peripheral clinical uses of the substance were still pervasive enough for it to not be completely regulated until the United States government moved to make it a Schedule III controlled drug in 1999. This added a degree of regulatory oversight as to how the drug was dispensed but still allowed it to be utilized for clinical purposes.

William Hurt in Altered States, a film loosely based on the experiences of John Lilly

The Russian research

In 1985, two Russian researchers hypothesized that ketamine could be a good drug to utilize in a psychotherapeutic context. It was short-acting, controllable, relatively accessible and known to induce psychedelic experiences. For the next decade, Evgeny Krupitsky and his team at the Leningrad Regional Center for Alcoholism and Drug Addiction Therapy pioneered what they called Ketamine Psychedelic Therapy.

Over the next decade, ketamine was used to treat more than 1,000 patients for an assortment of drug dependencies, primarily alcoholism. In a systemic study of the work, published in 1997, the researchers reported that the KPT process they developed resulted in zero major side effects, such as protracted psy­choses, flashbacks, agitation, or ketamine abuse. It also proved to be extremely effective in helping patients, with total abstinence rates for more than one year in KPT-treated alcoholic patients hitting around 65 percent compared to conventional treatment which was only successful in 24 percent of patients after one year.

For an extended period of time across the 1980s and early 1990s, this Russian team were extraordinarily the only researchers in the world investigating the therapeutic outcomes of ketamine. Krupitsky suggested this could be because Russia was not suffering from a culture of recreational psychedelic usage, which helped allow his work to continue for so long with no authoritative challenge.

“It seems to be an especially powerful tool in Russia, where there was no psychedelic revolution in the 1960’s and almost nobody knows what “psychedelic” means or can even imagine that this drug can be used for recre­ation,” the researchers concluded in their ten-year report.

Ketamine is known for generating a profoundly dissociative out-of-body experience

The 21st century resurgence

In the early 2000s, ketamine began to reemerge in Western research circles as a potential therapeutic agent, initially for depression. A very small studypublished in 2000 highlighted the drug’s impressive antidepressant qualities, but it was a 2006 study that really turned the tide.

The study, from the National Institute of Mental Health (NIMH), highlighted the remarkably rapid anti-depressant effects of ketamine. It was a small but strong piece of research involving a cohort of patients diagnosed with major, treatment-resistant depression. Two small doses of ketamine were administered, one week apart, and by the end of the first day 71 percent of subjects in the ketamine group reported a nearly 50 percent decline in their symptoms. Even more remarkable, after a week nearly a third of the ketamine group reported complete remission of their depressive symptoms.

This kind of rapid and immense effect was unheard of and the study hit the mainstream media, propelling ketamine into the news for something other than an illicit street use for the first time in years.

The rapid anti-depressant effect of ketamine has been a fundamental and exciting area of research in recent years with scientists slowly homing in on the extraordinarily unique qualities of how the drug operates on the brain. A 2017 study from Columbia University Medical Center revealed impressive results when examining patients suffering from acute suicidal thoughts.

The study, composed of 80 patients with clinically significant suicidal thoughts, displayed a major reduction in reducing such thoughts within 24 hours of a single low-dose infusion. A six-week follow up also found the effects impressively held for an extended duration, especially when compared to a control-group that were administered a sedative called midazolam.

A model of the ketamine molecule

But how does it work?

How the drug actually works to achieve its rapid anti-depressant effects is a hot area of research. While it has been known for several decades that ketamine blocks a protein receptor in the brain called N-methyl-D-aspartate (NMDA), it hasn’t been understood exactly where in the brain this mechanism could be operating.

A recent study from Zhejiang University in China excitingly revealed that this mechanism could be concentrated in the lateral habenula, an area of the brain often referred to as our “anti-reward center.” Overactivity in the lateral habenula has been strongly related to depression and the new study revealed that ketamine directly reduces neuronal activity in that region.

Ketamine’s broad use as a pain- and depression-relieving agent is finding burgeoning uses in treating other conditions peripherally connected to those symptoms. A growing body of anecdotal patient-driven evidence is suggesting the drug could be effective in treating fibromyalgia and chronic fatigue syndrome, two chronic conditions that are somewhat linked by widespread feelings of pain and fatigue.

In regards to fibromyalgia, some small studies have found ketamine to be incredibly effective in reducing acute pain related to the condition. The effects were frustratingly short-lived, unfortunately, but some patients have reported single infusions dulling pain for up to three weeks.

The use of ketamine to treat chronic fatigue syndrome is still in the nascent research stages, but a 2016 study revealed a fascinating insight into the drug as an anti-fatigue compound. While fatigue and depression are profoundly interlinked, the broader NMDA-blocking effects of ketamine are convincingly hypothesized to potentially improve the symptoms of patients suffering from chronic fatigue.

The 2016 study was small, and limited to patients being treated with ketamine for bipolar disorder during an episode of acute depression. It found that ketamine significantly improved symptoms of fatigue when compared to patients in the placebo group, with the anti-fatigue effects most prominent 48 hours after the initial infusion event. The study concludes by suggesting ketamine’s NMDA receptor inhibition could be a novel target for anti-fatigue interventions in a variety of conditions, including chronic fatigue syndrome.

The urban myth of ketamine as a horse tranquilizer became prominent as the drug moved into...

The rise of the ketamine clinic

Unlike other more restricted drugs, ketamine is still available for medical uses. This has led to the recent upsurge of ketamine clinics in the United States. Ketamine is legally approved for use as an anesthetic, but its off-label use for other conditions is not illegal.

Since around 2015, it is estimated that well over 100 ketamine clinics have opened up in the US. These clinics target patients looking for an alternate way to treat their depression. For up to US$1,000 a dose, patients can receive an infusion of ketamine either weekly or monthly. Different clinics have different treatment processes, from specific 10-week programs to more casual dose-by-dose appointments.

It’s the wild west of medical treatments out there, with no clear science on how long these treatments last, or how safe long-term ketamine use like this actually is. The CEO of Actify Neurotherapies, a chain of 10 treatment centers, said recently “It scares the hell out of me that this is still unregulated.”

Actify Neurotherapies is actively resisting the term “ketamine clinic,” recently rebranding itself as a mental health clinic that happens to also provide off-label ketamine treatments. While Actify is positioning itself at the more credible end of the off-label ketamine provider spectrum, it is still part of a troubling, unregulated industry with the science yet to offer real clarity on the best way this drug should be delivered.

Well over 100 ketamine clinics are operating in the United States

A little less psychedelic?

The giant hurdle facing most ketamine research is trying to find a way to overcome the often unpleasant dissociative psychedelic effects of the drug. While NMDA-receptor antagonism is looking like an exciting new pathway to treat a whole host of conditions, the side effects of ketamine are proving tricky to manage when implemented into broader clinical applications.

A recent Australian trial into a ketamine nasal spray for treating depression had to be aborted after several participants started to experience psychotic-like side effects. One of the researchers suggested the dose problems stemmed from inconsistencies in the nasal-delivery method.

“We saw a range of tolerance levels and we think it’s because one person’s blood vessels in the nose can be so different to the next person’s, and when you spray, it crosses the thin lining, gets taken into the blood and straight to the brain. Some people got huge hits.”

Several researchers are now racing to develop compounds chemically similar to ketamine that still act on NMDA receptors but can reduce the psychoactive side effects. One of the most promising new alternatives is called esketamine, and it is currently at the tail end of Phase III clinical trials.

Esketamine is an isomer of ketamine, and reportedly has slightly less dissociative characteristics compared to its sibling. It is thought to be twice as potent as ketamine, which means it is suggested that lower doses could have similar NMDA-inhibiting effects to ketamine without the equivalent hallucinogenic result.

Despite the FDA offering esketamine a breakthrough designation in 2016, suggesting the compound is highly effective and will be rapidly pushed through the trial process, results have been decidedly mixed over the past few years. Most recently, some of the early Phase III results suggest the compound is only mildly effective, and in some cases barely better than the placebo control.

Ketamine + therapy = success?

Of course, some researchers are finding ways to work with the compound’s extremely hallucinogenic properties. An exciting new trial currently underway at the University of Exeter and University College London is directly inspired by Evgeny Krupitsky’s 1980s research in Russia. The trial is called KARE – Ketamine for reduction of Alcoholic Relapse, and it is setting out to examine how well ketamine, in conjunction with psychotherapy, can reduce alcohol dependence and promote abstinence.

The rigorous study, which is double blind and placebo-controlled, involves subjects being administered one dose of ketamine a week for a period of three weeks, alongside seven sessions of cognitive behavioral therapy. The study has a six-month follow-up phase to better understand the long-term effects of this kind of ketamine-assisted psychotherapeutic treatment.

Unlike the attempts to create a less psychoactive compound, this research suggests the holistic effect of ketamine could be vital to its absolute efficacy. The often unwanted hallucinogenic effects may very well be important. And unlike some of the ketamine clinics popping up around the US, this trial offers ketamine within the context of a controlled series of psychotherapy sessions helping patients integrate their experiences into positive outcomes.

The story of ketamine is a curious one, defiantly unlike other psychedelic substances being co-opted for medical uses. Ketamine is essentially legal, prescribable, yet still wholly experimental. It works on the brain in a completely novel way and we are only just understanding its broad potential uses.

With the rise of ketamine clinics, a strange kind of clinical practice has jumped ahead of research, giving rise to a wild west of drug providers administering the compound as a magic bullet for anything and everything in an unregulated landscape. More research undeniably needs to be done before we understand this deeply mysterious and unique drug, but it is looking like it will certainly become a fundamentally important compound in a bright future of psychedelic medicine.



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New Drug Combo Shows Promise for Treatment of Depression and Addiction

Drug Combo Shows Promise for Depression and Addiction
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The combination of naltrexone and ketamine can help treat both symptoms of addiction and depression, a preliminary study by Yale University researchers suggests.

Substance abuse and depression are common in many patients, and efforts to treat both conditions simultaneously have had limited success. One recent study suggested that the antidepressant effects of ketamine might blunted by administration of naltrexone, used to limit cravings of those addicted to opioid drugs and alcohol.

A preliminary study of five patients suffering from both depression and substance abuse disorders suggest that isn’t the case. The study was published Jan. 9 in the journal JAMA Psychiatry.

The results “raise the possibility that for people who have depression complicated by substance abuse disorders, the combination of ketamine and naltrexone may be a strategy to explore in the effort to optimally treat both conditions,” said senior author John Krystal, Yale’s Robert L. McNeil Jr. Professor of Translational Research; professor of psychiatry, neuroscience, and psychology; and chair of the Department of Psychiatry.

Krystal and lead author Gihyun Yoon, assistant professor of psychiatry, treated the five patients suffering from depression and alcohol use disorder with a long-lasting form of naltrexone and then administered ketamine. Four of the five responded to the first ketamine dose and all five found relief from depression after multiple doses.

The study also challenges the idea that ketamine might produce antidepressant effects by stimulating opiate receptors.

Krystal cautioned that larger studies are needed to confirm beneficial effects of the combination treatment.

Krystal and Yoon have provisional patents on the use of ketamine and naltrexone to treat comorbid depression and substance abuse.

The study was primarily funded by the U.S. Department of Veterans Affairs.

Publication: Gihyun Yoon, et al., “Association of Combined Naltrexone and Ketamine With Depressive Symptoms in a Case series of Patients With Depression and Alcohol Use Disorder,” JAMA Psychiatry, 2019; doi:10.1001/jamapsychiatry.2018.3990

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Radical ketamine therapy could treat alcohol addiction

There is a growing body of research to support the idea that ketamine, a horse tranquiliser, can be used to disrupt harmful patterns of behaviour.
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A one-off dose of the drug could help alcohol addicts reduce their intake by ‘erasing’ drink-related memories, say psychologists testing treatment.
There is a growing body of research to support the idea that ketamine, a horse tranquiliser, can be used to disrupt harmful patterns of behaviour

Scientists believe that a radical treatment involving the tranquilliser ketamine could help overcome alcohol addiction by “erasing” drink-related memories.

Psychologists based at University College London are testing whether a one-off dose of the drug could help hazardous drinkers who are trying to reduce their alcohol intake. Alcohol addiction is notoriously difficult to treat, and there are few effective therapies available.

First ‘gold-standard’ trial of ketamine’s anti-depressant effects launched

 Read more

Using a recreational drug to treat addiction may sound counterintuitive, but the researchers say there is a growing body of research suggesting that ketamine can be used to disrupt harmful patterns of behaviour.

Ravi Das, one of the lead researchers, said: “There is evidence that it could be useful as a treatment for alcoholism.”

Crucially, ketamine can disrupt the formation of memories, and scientists believe that this property could be harnessed to over-write the memories that drive addiction and harmful patterns of behaviour.

“Memories that you form can be hijacked by drugs in some people,” said Das. “If you were an alcoholic you might have a strong memory of being in a certain place and wanting to drink. Those memories get continuously triggered by things in the environment that you can’t avoid.”Advertisement

For instance, seeing a glass of beer, hearing the clinking of glasses or even arriving home from work may trigger memories of the rewarding sensation of taking a drink – and might prompt a person to follow this urge.

“The main problem is the really high relapse rate after treatment,” said Das. “People can successfully quit using over the short term while they’re being monitored in the hospital … but when they return home they’re exposed to those environmental triggers again.”

There is increasing evidence, however, that memories are less stable than once assumed and may be open to manipulation.

Each time our brain accesses a memory, the neural connections that encode it are temporarily destabilised, meaning that our recollection can be slightly altered before it goes back into storage. This is one reason why, in everyday life, people can recall wildly different versions of the same events.

In the clinic, scientists believe this short period of instability, represents a window of opportunity. Ketamine blocks a brain receptor called NMDA, which is required for the formation of memories. So the logic is that giving someone the drug just as a memory has been destabilised could help weaken the memory, or even erase it.

 Read more

A similar approach with a different drug was shown to eradicate people’s phobia of spiders. And research in rats that were made to be addicted to cocaine showed that the memories underpinning their addiction could be completely wiped out using a similar strategy (although this involved injecting a chemical into the brain).

In the UCL trial, the scientists will intentionally trigger alcohol-related memories by placing a glass of beer in front of the participants, who are all heavy drinkers. They will then disrupt the memory, by surprising the participant (the team is not disclosing the exact details as this could bias the results).

Participants will then be given either a ketamine infusion, with a concentration equivalent to a high recreational dose, or a placebo. The team will follow up the people for a year and monitor whether their drinking has changed and by how much.

In total the scientists are aiming to include 90 people in the trial and more than 50 have already taken part. It involves people who drink harmful quantities of alcohol, but excludes anyone who meets the clinical criteria for alcoholism. The participants were drinking at least 40 units a week for men (equivalent to four bottles of strong wine) and 28 units for women, and drinking on at least four days. The UK needs common sense about ketamine

Nikki, 31, who works as a consultant in London said she decided to take part in the study when she had some time off between jobs and realised she was drinking more than she wanted to. “It’s just in the culture, that’s what all my friends are like. Everyone drinks to excess,” she said.

She described the experience of being given the ketamine as “overwhelming and intense”, but not unpleasant. “My body felt like it was melting away,” she said. “It was quite psychedelic, I felt untethered from my body.”

In the week after the session, she said, she felt in an “incredibly positive mood” and that since taking part she has been more conscious about deciding whether to have a drink, although said this could also be linked to starting a new job and taking up meditation. “In the past, there were occasions where I would be drinking and I’d be on autopilot ‘Let’s get another drink’,” she said.

If the trial yields promising results, the team hope that the approach could form the basis for therapy sessions targeted at alcoholics and people who are drinking unhealthily. However, they acknowledge that there may be resistance to the use of a recreational drug to treat people with addiction.

“There’s just the general social attitude that everything that’s illegal is terrible. There will obviously be that kind of narrow-sighted pushback,” said Das. “But if it’s safe and effective enough it should be recommended.”

Andrew Misell, a spokesman for Alcohol Concern, said: “The researchers have quite rightly highlighted what a lot of people in recovery from alcohol problems know from experience, namely that cues or triggers like the smell of beer can cause a relapse even after long periods of abstinence. Any work looking at how people can overcome these pitfalls is going to be useful.”

However, he added, no drug-based therapy is risk-free “and that certainly includes ketamine”.

Professor Michael Saladin, of the Medical University of South Carolina, is looking at similar approaches to help people quit smoking. “There is a vast animal research literature that suggests memories can be manipulated following reactivation,” he said. “I am convinced that there is sufficient evidence to believe that memory reconsolidation can be harnessed for clinical purposes.”

Problematic alcohol use is a big public health problem in the UK, but could ketamine help?
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January 2018 has come to an end and with it the month that people increasingly use to abstain from alcohol. It is still unknown whether Dry January has a lasting effect on drinking behaviours, and people with an alcohol dependency problem should always seek support from their GP before going through detox. Nonetheless, Dry January undoubtedly drives a critical conversation about alcohol use and provides an opportunity for us to reconsider our relationship with alcohol (one of the main goals of the charity Alcohol Concern, who support the challenge).

While overall alcohol consumption in the UK is falling, alcohol abuse still represents the fifth biggest risk factor for illness, death and disability across all ages. With current treatments often failing to prevent relapse in the long term, researchers are investigating the possibility of using ketamine combined with psychological therapy to help people stay dry, and not just for January. Despite its often cited use as a recreational drug and “horse-tranquilizer” ketamine is also the most widely used anaesthetic in humans. Administered appropriately in a controlled and safe medical environment, ketamine may also have benefits in the treatment of drug problems.

Say Why To Drugs – does alcohol put our health on the rocks?

Evidence for this originally came from a research group in Russia in the 1980s. In this study, patients who had alcohol problems were given three weekly ketamine treatments in conjunction with psychological therapy. After one year, 66% of patients who underwent this treatment regime were abstinent, in comparison to 24% of patients who received treatment as usual, without any ketamine. This abstinence rate is much greater than those documented with any other relapse prevention method.

Inspired by the promising results seen in Russia, we are now conducting the KARE trial (Ketamine for reduction of Alcoholic Relapse) at the University of Exeter and University College London. In this trial participants who have made the decision to abstain are administered ketamine once a week for three weeks. Participants also receive seven sessions of cognitive behavioural therapy to aid their quit attempt and are followed up for six months. Unlike the earlier study, this trial is placebo controlled, thus participants have an equal chance of receiving either ketamine or a matched placebo as well as either cognitive behavioural therapy or alcohol education as a placebo for therapy. It is also double-blind, meaning neither the participant nor the researcher know whether the active treatment or a placebo treatment are administered. This controls for placebo effects and bias due to expectancies of the researcher – putting the original findings to the test with a more rigorous research design.

 The media has a problem with alcoholism – and it’s stopping people getting help

James Morris Read more

Why might ketamine help people stay sober? Recent studies have demonstrated that ketamine has rapid and powerful anti-depressant properties, while people with alcohol problems often also experience symptoms of depression. The direction of the relationship between alcohol problems and depression is not clear, but depressive symptoms are thought to be a common trigger for relapse. Treating people who have alcohol problems with ketamine, therefore, could help them to remain abstinent for longer by lifting their mood.

Furthermore, laboratory research has demonstrated that ketamine promotes the growth of new neurons and connections in the brain. These processes are essential to learning and memory, and are suggested to be impaired in both depression and problematic alcohol use. Thus ketamine might make people more receptive to new information and able to plan effectively for the future, which in turn may enhance the effect of psychological therapy.

We do not yet know how effective the ketamine treatment will be. However, well-designed research studies, such as the KARE trial, could be critical in helping people achieve their abstinence goals.

https://www.pharmaceutical-journal.com/news-and-analysis/features/the-secret-life-of-ketamine/20068151.article?firstPass=false

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There is an urgent need for better medications that work quickly for treatment of major depression and bipolar disorder. The treatment should also be tolerable and work for depressed patients who have not responded to conventional treatments, ie, who have treatment-resistant depression (TRD).

Ketamine is a medication that is used intravenously for anesthesia, but multiple controlled trials have now demonstrated a rapid antidepressant response to a single intravenous infusion of ketamine. Controlled studies of regular infusions appear promising, but the need for regular IV infusions is not something that is appealing to most patients and often results in non-compliance. And, oral ketamine is extensive broken down by the liver before it can be absorbed by the body, so oral therapy is not a viable option. Therefore, the intranasal route has been investigated.

Intranasal drug delivery offers a route to the brain that bypasses problems related to gastrointestinal absorption, first-pass metabolism, and the blood-brain barrier; and the onset of therapeutic action is rapid. Intranasal medications avoid the inconvenience and discomfort of IV therapy. Intranasal medications have been used to treat migraine, acute and chronic pain, Parkinson’s disease, cognitive disorders, autism, schizophrenia, social phobia, and depression.

In a randomized, double-blind, placebo-controlled, crossover trial conducted in 20 patients with major depression, physicians and researchers at the Icahn School of Medicine at Mount Sinai, New York, tested the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial. The researchers found that a single intranasal dose of ketamine (50 mg) outperformed placebo; the response rate was 44% versus 6%, respectively. Anxiety ratings also decreased significantly more with ketamine. Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo. Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters like blood pressure.

Intranasal ketamine represents a promising advance in treatment-resistant depression (TRD) therapeutics. Most studies report a duration of response up to 7 days and remission up to 3-5 days after a single dose. “Most adverse events … subsided spontaneously by 60 to 90 minutes post dose,” said Vanina Popova, MD. In addition, “there was no pushback” to the nasal delivery system. “The route of administration was well received, and it was certainly more convenient than intravenous administration,” she said.

Intranasal ketamine is not commercially available, but the clinical use of intranasal ketamine is increasing internationally. Research has concluded that the drug formulation, the delivery device, the technique and individual patient factors play an important role in tolerability and efficacy when using intranasal ketamine for Treatment Resistant Depression.

Intranasal ketamine has been reported in studies to help depressed patients who have not responded to conventional therapy with minimal side effects. Ask our pharmacist for more information about compounded intranasal ketamine. We customize medications to meet each patient’s specific needs.http://www.novahealthrecovery.com/NOVA Health Recovery Ketamine Treatment Center | 703-844-0184 | Alexandria, Va 22306

References:
Depress Anxiety. 2016 Aug;33(8):698-710. 
Gen Hosp Psychiatry. 2015;37(2):178–184. 
J Clin Psychiatry. 2015 May;76(5):e628-31. 
Biol Psychiatry. 2014 Dec 15;76(12):970-6. 
American Psychiatric Association (APA) 2018. Abstracts P7-065 and P8-054, presented May 8, 2018.
Psychiatry Clin Neurosci. 2018 May 10. 
J Clin Psychiatry. 2017 Jun;78(6):e674-e677. 
CNS Drugs. 2018 May 7. [Epub ahead of print]
J Psychopharmacol. 2018 Apr;32(4):397-407.

Ketamine 25mg – 100 mg Nasal Spray

BACKGROUND: The N-methyl-D-aspartate glutamate receptor antagonist ketamine, delivered via an intravenous route, has shown rapid antidepressant effects in patients with treatment-resistant depression. The current study was designed to test the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial.
METHODS: In a randomized, double-blind, crossover study, 20 patients with major depression were randomly assigned, and 18 completed 2 treatment days with intranasal ketamine hydrochloride (50 mg) or saline solution. The primary efficacy outcome measure was change in depression severity 24 hours after ketamine or placebo, measured using the Montgomery-Åsberg Depression Rating Scale. Secondary outcomes included persistence of benefit, changes in self-reports of depression, changes in anxiety, and proportion of responders. Potential psychotomimetic, dissociative, hemodynamic, and general adverse effects associated with ketamine were also measured.
RESULTS: Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (t = 4.39, p < .001; estimated mean Montgomery-Åsberg Depression Rating Scale score difference of 7.6 ± 3.7; 95% confidence interval, 3.9-11.3). Response criteria were met by 8 of 18 patients (44%) 24 hours after ketamine administration compared with 1 of 18 (6%) after placebo (p = .033). Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters.
CONCLUSIONS: This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine. Treatment was associated with minimal adverse effects. If replicated, these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression

Link

Link to Intranasal Ketamine

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What is ketamine?

Ketamine Nasal Spray
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Ketamine is a drug currently approved by the FDA for use as a general anesthetic during minor surgical procedures such as biopsies. It is widely known as a recreational drug because of its ability to induce cognitive-dissociative, hallucinogenic, and euphoric states in humans. Recently, it has been implicated in research as a potential therapeutic agent in depression especially in patients who have failed previous standard therapies.

Why ketamine?

Standard pharmacologic therapies for depression take several weeks of treatment before patients experience relief. Ketamine is different in that it has been shown to reduce depression symptoms and suicidal ideation in as little as forty minutes. This is considered a potentially lifesaving breakthrough in the treatment of depression because ketamine can rapidly reduce symptoms especially in emergency situations.

How does it work?

The most common medications used in depression affect serotonin in the brain. Ketamine works by a different mechanism. It has been shown to block the glutamate receptors in the brain resulting in its famous hallucinogenic effects. Ketamine has been shown to act on several other receptors, but it is theorized that at low doses, blocking glutamate receptors in the brain may be the reason for its anti-depressive effects.

Who should (and shouldn’t) take ketamine?

Ketamine has not been approved by the FDA for treatment of depression. Although, because of new studies, psychiatrists have been prescribing ketamine “off-label” for patients who did not respond to selective serotonin reuptake inhibitors (SSRIs) such has Celexa (citalopram), Zoloft (sertraline), or Prozac (fluoxetine) for immediate treatment of symptoms.

Ketamine has been shown to transiently yet significantly increase blood pressure following administration. Patients with high blood pressure should use caution when using ketamine. Ketamine has also been shown to be associated with increases in psychosis or dissociative properties.

Ketamine nasal sprays offer a quick and convenient way to administer ketamine for patients who need immediate relief, although they are currently not available commercially, so you will not find them at your local community pharmacy. Compounding pharmacies have the proper experience, equipment, and personnel to safely compound and customize this medication for you.

References

  1. Ketalar [package insert]. Chestnut Ridge, NY 10977: Par pharmaceutical; 2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf
  2. Browne CA, Lucki I. Antidepresssant effects of ketamine: mechanisms underlying fast-acting novel antidepressants. Front Pharmacol December 2013.
  3. Lapidus K, Levitch CF, Perez AM, et al. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychology 2014;76:970–976
  4. Sanacora G, Frye MA, McDonald W, et al. A consensus statement on the use of ketamine in the treatment of mood disorders. JAMA Psychiatry 2017;74(4):399-405.

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The woman had used oxycodone for almost a decade but told her doctors she had been sober for two years. She never touched narcotics during her pregnancy, she said, and had completed rehab.

But her newborn son was in withdrawal: jittery, screaming and requiring an infusion of morphine to stay alive. The infant craved drugs, but why?
Amid an opioid epidemic, the boy’s doctors didn’t blame heroin, fentanyl or other illicit substances. Instead, they said, the infant had grown dependent on a controversial herbal supplement: kratom.

‘A false sense of safety’

According to a case report published Wednesday in the journal Pediatrics, both the unnamed woman and her infant passed urine drug screens that looked specifically for oxycodone and other opioids. But those tests didn’t look for kratom, a legal drug that has opioid-like effects at high doses.
The plant, which is native to Southeast Asia, is typically used to treat pain and curb opioid cravings. Acting on the same brain receptors as morphine and similar drugs, it is hailed by someas a solution to the opioid epidemic but derided by the US Food and Drug Administration as a potentially dangerous psychoactive drug.
The mother denied using any substances during her pregnancy — legal or otherwise — but her husband told doctors that she drank kratom tea daily to treat her withdrawal symptoms and help with sleep.
“I fear that women making genuine commitments to overcome their dependency may develop a false sense of safety by using a substance that is advertised as a non-opioid alternative,” said Dr. Whitney Eldridge, a neonatologist for BayCare Health System in Florida who was lead author on the case report.
The mother might have been well-intentioned, but because tests showed no other drugs in her or the infant, her doctors said kratom probably caused her son’s condition, known clinically as neonatal abstinence syndrome. On his eighth day of life, after he had been weaned off opioids and observed without any medications, the boy was discharged to his parents.
It’s rare, but FDA Commissioner Dr. Scott Gottlieb said in a statement that “this case is not unique.” He said the FDA “is aware of four other cases involving neonates exposed to kratom while in utero who experienced neonatal opioid withdrawal syndrome after term delivery.”
Gottlieb, whose agency has issued a variety of warnings on kratom, called the new report “a tragic case of harm” and said it “further illustrates the concerns the FDA has identified about kratom, including the potential for abuse and addiction.”
And though Eldridge hopes more research will help lawmakers better regulate kratom, she believes that physicians today “need to counsel women who are pregnant about the risk of kratom such as they would any other legal substance that can have ill effects on their newborn.”

Experts urge caution, cast doubt

Some experts are hesitant to draw any conclusions from the report. They note that although maternal kratom use could theoretically cause neonatal abstinence syndrome, the case did not explicitly link kratom to the infant’s withdrawal symptoms.
“I’m not surprised that this is possible,” said Dr. Andrew Kruegel, an associate research scientist at Columbia University, “because kratom certainly has opioid effects and can induce tolerance in users, especially at higher doses.”
But Kruegel, who has studied the plant for seven years, noted that doctors weren’t able to test the purported kratom itself. “The main limitation is that we don’t know anything about the dosage that the mother was taking,” he said. “Without that information, you can’t really extrapolate too much.”
And the mother might not have been taking kratom at all, said Dr. Edward W. Boyer, an associate professor at Harvard Medical School and a physician in the Department of Emergency Medicine at Brigham and Women’s Hospital.
“It’s the husband who reported the kratom use,” he said. “The wife who actually ingested the product, who thought it was kratom, and the authors of the case report itself, none of those people actually verified that she was ingesting kratom.”

Kratom’s rocky past and uncertain future

Despite the FDA’s warnings, kratom is easy to buy and is sometimes sold as a tea in cafés. The nonprofit American Kratom Association estimates that 3 million to 5 million Americans use the substance, and the group says it’s open to warning labels on kratom products.
“We believe that, as in many supplements, there should be a warning that pregnant women shouldn’t take this,” Dave Herman, the association’s chairman, said. “That’s not because we think it’s detrimental. It’s because it’s a safety measure.”
Kratom acts on opioid receptors, which the FDA says is evidence of its potential for abuse. The agency points to 44 deaths associated with kratom, but Kruegel said that “if you look at those 44 deaths, the vast majority of them involve other substances, including other strong opioids.”
Boyer said kratom may have other risks, such as seizures, but he noted that it might be safer than most opioids because “there does not seem to be respiratory depression when kratom is used alone.”
Respiratory depression — slow and ineffective breathing — is what makes opioid overdoses so deadly. That’s why Boyer believes well-regulated kratom could one day be used in the fight against opioid addiction, steering users away from more dangerous drugs.
“If you do the right thing and do the rigorous studies, then there is no reason why [kratom] shouldn’t be a prescription pharmaceutical that serves as a bridge to formal drug treatment, particularly for individuals who can’t get into therapy,” Boyer said.

Challenges to developing kratom-based drugs

The American Kratom Association says there’s little incentive for pharmaceutical companies to study kratom as a potential prescription drug, especially because they can’t patent the raw plant.
“If I’m a drug company, I think that it costs somewhere, depending on who you speak to, between $1.2 and $1.8 billion to bring a new drug to market,” Herman said. “Who would spend that kind of money when some other guy can just get on a boat, ride down a river and grab it off a tree?”
Because kratom is considered a dietary supplement, manufacturers don’t need FDA approval to sell it as long as their products don’t claim to cure or treat specific conditions or symptoms.
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But some companies have done just that, drawing the FDA’s ire for saying their products could “relieve opioid withdrawal” or “treat a myriad of ailments.” The association says those cases are anomalies.
“The reality is, our belief is, this is America,” Herman said. “And if a product is useful for your health and well-being, you should have the right to take it, as long as it doesn’t harm you. And we haven’t seen any evidence of that harm.”
The FDA, however, continues to warn against kratom, even suggesting that it could worsen the opioid epidemic.
“Kratom has never been studied in humans,” Gottlieb said in the statement. “What consumers and health care providers need to understand is that there are no proven medical uses for kratom. Instead, as the FDA has warned, kratom can cause serious harm and is contributing to the opioid crisis.”