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Monday, June 26, 2023

FDA Issues First Ever Guidance for Clinical Trials with Psychedelic Drugs

"Socalj" for Borderland Beat

The U.S. Food and Drug Administration (FDA) is issuing guidance to provide general considerations to sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders).

Psychedelic is used as shorthand to include classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin (Magic Mushrooms) and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).

This is the first FDA draft guidance that presents considerations to the industry for designing clinical trials for psychedelic drugs.

There has been growing interest in the therapeutic potential of psychedelic drugs in recent years. They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders, and other conditions. However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges that require careful consideration.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety, and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

The document describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety, and new drug application requirements.

For example, psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. As a result, there is the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development.

For psychedelics that are currently Schedule I controlled substances, the draft guidance notes that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements.

The evidentiary standard for establishing the effectiveness of psychedelic drugs is the same as for all other drugs. However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled. The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring, and the importance of characterizing dose response and the durability of any treatment effect.

The agency filed the 14-page document two days after a bipartisan coalition in Congress led by Rep. Dan Crenshaw (R-Texas) introduced legislation directing the issuance of clinical trial guidelines.
It also came as 10,000 attendees and hundreds of exhibitors converged on Denver for what was billed as the "largest psychedelic conference in history," with guests ranging from New York Jets quarterback Aaron Rodgers to National Institute of Mental Health director Joshua Gordon.

"People want to enter the market without having to do the experimentation and the safety and efficacy analysis," said Kimberly Chew, an attorney at Husch Blackwell focused on psychedelics and emerging therapies. Most don't want to go through the FDA approval process because it's expensive, resource intensive, and "they just want their business to thrive," Chew added.

Businesses might instead opt to follow state frameworks for allowed uses, leaving the psychedelics they market as unapproved and illegal under federal law. At least 25 states have considered legislation, with most introduced in the past two years, per researchers.

Oregon and Colorado are the only states to have decriminalized the supervised use of psychedelics, though neither has endorsed it as a mental health treatment.

Source FDA, Axios


  1. CIA MK Ultra Part 2

  2. The first ever guidance ? You sure about that ?

  3. The last thing needed is more drugs. Drugs make people violent.
    Look at the young man that was shot and killed at a fried chicken restuarant in Chicago, by a mother and her 14 year old son.

    RIP Jeremy Brown

    1. Psychedelics don't make people violent under therapeutic conditions.

    2. Some people can handle the effects better than others. It's like any other prescribed medicine. The side effects vary depending on the person. Not all good, not all bad.

    3. violence is normal,problem is tolerance for degenrate behavior and letting mentally ill people roam the streets among normal people.

    4. Even under therapeutic conditions they may cause violence.

    5. Holy crap. How seriously uninformed can a group be? Psychedelics have never ever made me want to be violent. And 99.9% of the time it’s the same with everyone else was who has ever tried them. It’s about mental health. It’s not meth or blue. Get a clue people

  4. Please educate yourselves. These treatments save lives. I did Ketamine treatments with a doctor a few years back, likely the only reason I'm still here. It actually helps regrow areas of the brain that are damaged in those that have PTSD, and major depression. The way I was described by the doctor is the analogy of, the K acts as water all of a sudden flowing thru a barren desert making areas start to regrow. It is the ONLY thing found to pull someone out of suicidal ideation in only 4 minutes. This shouldn't be some do at home thing though. It should be done with medical professionals in a controlled environment. Doing it recreationally vs with a trained professional is a huge difference. Sorry for the rant, just something I care strongly about and always try to spread the word about in hopes lt will help someone.

    1. I got PTSD and I also got extreme pain and nerve damage from traumatic brain injury and need ketamine. Dammit.

  5. That’s great you had a good experience with ketamine therapy. You’re absolutely right ketamine has been scientifically proven in Switzerland to repair damage flattened and abated neurons. I tried to get this treatment many times, but my psychiatrist and physical doctors would not give me a referral like punks.

  6. 5:41 look up doctors in your area and make some calls. My first treatment was in Nashville, TN (not the state I live in) The doctor was a psychiatrist. I didn't have any type of referral, just told them my issues and set up an appointment. They do an assessment and see if you're a candidate and go from there. Insurance won't cover it. It is crazy expensive but was better than the alternative of no longer being here. What state are you in? Totally understandable if you don't feel ok telling that.

  7. There is a Ketamine nasal spray called Spravato that is FDA approved, and Spravato has a customer savings program that along with my insurance pays for all of it. For the first month, I go 2 times a week for 2 hour treatment sessions that are at the psych clinic. After the first month, I‘ll go once a week for a 2 hour treatment. After the second month of treatments, it goes down to every two weeks for as long as needed. It saved my life. Before treatment, I had multiple suicide attempts and couldn’t get out of bed because I was so depressed. By the third week of treatments, my depression is gone and I’m going back to work tomorrow, for the first time in 6 months. I didn’t know that the FDA approved it and insurance would cover everything up until after I got out of the hospital for the last attempt, and I got an appointment with a psychiatrist that was listed on the Spravato website that are in my area, and are certified and approved by the state. I’ve tried every antidepressant and benzodiazepine medications known, but they made my mental health worse, so I’m so grateful that I found out that Spravato was finally approved and covered by insurance.

    1. Thanks for that info. I am 8:44 and 8:02 I did my initial 3 day a week for 2 weeks infusions in 2018 at $500/per treatment. I have had 2 boosters since one infusion and the other time I saw a doctor while in FL and they did take home lozenges which I did not think worked any where close to the same. Thank you for sharing all that, that's amazing insurance is helping out. I'm also really happy it's worked for you. I totally understand and empathize. Most don't realize how debilitating PTSD/ major depression is and how alone people feel at that point. It's amazing how much these treatments can actually save your life.


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