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The Latest on Ketamine, Psilocybin, and MDMA FDA Approval (and Other Psychedelic Advancements)

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How and why we engage with psychedelic compounds is quickly changing, thanks in large part to a plethora of ongoing medicinal research and shifts in policy. Compounds once known for their recreational use —such as psilocybin and MDMA— are being closely examined for their potential in various treatments related to mental health.

Here’s a summary of the latest news regarding research, trials, and advancement of U.S. Food and Drug Administration (FDA) approvals for a number of psychedelic medicines.

Ketamine Research, Legislation, and Approval Tracks

Ketamine is currently being used off-label in clinics across the U.S. to help treat mental health conditions and chronic pain.

In 2019, ketamine derivative esketamine (Spravato) was approved by the FDA to be used as an intranasal spray for those with treatment-resistant depression. Since then, there have been more approved clinical trials to examine the efficacy of ketamine for a number of conditions.

Earlier this year, the administration approved PharmaTher, a clinical-stage psychedelics biotech company, in a Phase 2 clinical study with ketamine to treat Parkinson’s disease.

In early August, the same company was granted a special status known as “orphan drug designation,” to research ketamine treatment for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease.  

Additional ketamine research was published in the September/October issue of the Harvard Review of Psychiatry, including a study on ketamine’s impact on various cognitive processes. It found that the use of ketamine and esketamine had no adverse effect on memory, attention and other cognitive functions.

“Ketamine and esketamine do not seem to exert significant deleterious neurocognitive effects in the short or long term in individuals with treatment-resistant depression. Results suggest neuropsychological functions and brain areas commonly impaired in treatment-resistant depression may especially benefit from subanesthetic ketamine infusions,” the report concludes.

Psilocybin Research, Legislation, and Approval Tracks

Positive progress has been made in the U.S. related to medicinal applications of psilocybin, which is known colloquially as “magic mushrooms.”

Last year, Oregon became the first state to approve the legal use of psychedelic mushrooms in licensed facilities. Earlier this summer, Texas and Connecticut followed a similar path, legally approving research into how psilocybin can help people suffering from Post Traumatic Stress Disorder (PTSD).

Toronto-based company Revive Therapeutics announced this month that it was entering into FDA clinical studies with psilocybin to test the drug’s impact on those with methamphetamine use disorder and stroke. It’s partnered with University of Wisconsin-Madison’s School of Medicine and Public Health and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin.

Meanwhile, Johns Hopkins University’s Center for Psychedelic and Consciousness Research has a host of psilocybin-related studies underway. These include ongoing studies on  anorexia nervosa, smoking cessation, depression, and Alzheimer’s Disease.

A study published in February looked at a large analysis of various psilocybin studies in order to offer guidance on optimal dosing practices of psilocybin.

In July, a study published in the New England Journal examined Psilocybin versus Escitalopram, the generic version of Lexapro, an SSRI, for the treatment of depression. It found that “secondary outcomes generally favored psilocybin over escitalopram, but the analyses of these outcomes lacked correction for multiple comparisons.”

MDMA Research, Legislation, and Approval Tracks

MDMA, known colloquially as molly or ecstasy, has been subject to research that suggests it can help with various mental health conditions. One organization making huge strides in MDMA research is the Multidisciplinary Association for Psychedelic Studies (MAPS).

Researchers at MAPS are working on a plan that would see MDMA-assisted therapy become an FDA-approved, prescribable treatment by 2023. The organization released the results of a Phase 3 clinical trial that determined that MDMA-assisted therapy may be a safe and effective treatment for PTSD.

The study, published this year in Nature Medicine, found that MDMA brought relief to participants who suffered from PTSD, when the treatment was paired with talk therapy.

MAPS is simultaneously researching whether MDMA-assisted therapy can help heal wounds from psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas. They’ve also sponsored completed studies on MDMA-assisted therapy for autistic adults with social anxiety, and MDMA-assisted therapy for anxiety related to life-threatening illnesses.

Other Psychedelic Medicine News and Research

In other psychedelic medicine news…

In July, a U.S. House appropriations resolution, HR 4502, was passed with secondary guidance to contribute funds toward psychedelic research for treatments for PTSD, major depressive disorder, and other mental health conditions. The funding would focus on treatments with “Breakthrough Therapy” designation, which allows biotechnology and pharmaceutical companies an expedited review process for experimental drugs that are shown to have treatment advantages over existing therapies for diseases that are difficult to treat.

In late July, biotech company Mind Medicine Inc. launched a Phase 1 clinical research study on DMT, colloquially known as the 'Spirit molecule. The compound has shown to have promising effects on issues like depression and anxiety.

The Psychae Institute recently opened in Melbourne, Australia. The multimillion-dollar research institute will develop new pharmaceutical-grade psychedelic medicine meant to target mental health disorders, and will be a collaboration from researchers around the world. It will study compounds such as psilocybin, MDMA and DMT.

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Mindbloom's Transform newsletter brings you up-to-date psychedelic medicine research and advancements, as well as best practices to make the most of your healing journey.

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Disclaimer

Sources

This article is for informational purposes only and is not intended to be a substitute for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. If you are in a life-threatening situation, call the National Suicide Prevention Line at +1 (800) 273-8255, call 911, or go to the nearest emergency room.

Important FDA Safety Information

Ketamine is not FDA-approved for the treatment of depression or anxiety. Learn more about off-label uses here.

Side effects of ketamine treatment may include: altered sense of time, anxiety, blurred vision, diminished ability to see/hear/feel, dry mouth, elevated blood pressure or heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses).

Do not proceed with ketamine treatment if any of the following apply to you:

  • Allergic to ketamine
  • Symptoms of psychosis or mania
  • Uncontrolled high blood pressure
  • CHF or other serious heart problem
  • Severe breathing problem
  • History of elevated intraocular or intracranial pressure
  • History of hyperthyroidism
  • Other serious medical illness
  • Pregnant, nursing, or trying to become pregnant

Ketamine has been reported to produce issues including, but not limited to, those listed below. However, lasting adverse side-effects are rare when medical protocols are carefully followed.

While ketamine has not been shown to be physically addictive, it has been shown to cause moderate psychological dependency in some recreational users.

  • In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
  • Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders.
  • Users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your MindBloom clinician before proceeding with treatment.
  • The dissociative effects of ketamine may increase patient vulnerability and the risk of accidents.

To promote positive outcomes and ensure safety, follow these ketamine treatment guidelines:

  • Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep
  • Refrain from taking benzodiazepines or stimulants for 24 hours prior to treatment
  • Continue to take antihypertensive medication as prescribed
  • Avoid hangovers or alcohol intake
  • Refrain from consuming solid foods within 3 hours prior to treatment and liquids within 1 hour prior to treatment
  • Ketamine treatment should never be conducted without a monitor present to ensure your safety
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The Latest on Ketamine, Psilocybin, and MDMA FDA Approval (and Other Psychedelic Advancements)