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FDA's First Draft Guidance on Clinical Trials with Psychedelic Drugs Now Available for Comment


On Monday June 26, the US Food and Drug Administration (FDA) began accepting public considerations for researchers investigating the use of psychedelic drugs for the potential treatment of medical conditions such as psychiatric or substance use disorders.

FDA's First Draft Guidance on Clinical Trials with Psychedelic Drugs Now Available for Comment ©agsandrew/AdobeStock

The draft guidance offers the first opportunity for potential research sponsors to to consider foundational aspects of designing clinical trials for psychedelic drugs.

The comment period will close August 25, 2023.

The purpose of the guidance is to advise researchers on study design and other considerations as they develop medications that contain psychedelics. In this case, psychedelics are reffered to "classic psychedelics," such as psilocybin and lysergic acid diethylamide that act on the brain's serotonin system, as well as "entactogens" or "empathogens" such as methylenedioxymethamphetamine.

There has been growing interest in the therapeutic potential of psychedelics in recent years, according to the FDA. They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders, among other conditions.

However, designing clinical studies to evaluate the safety and effectiveness of these drugs presents a number of unique challenges that require careful evaluation.

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

For example, psychedelic drugs produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. This makes evaluation for the potential for abuse paramount during the clinical development process.

For psychedelics that are currently Schedule I controlled substances, the draft guidance notes that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration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

The standard for establishing 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.

"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, MD, director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research, in an FDA press release.

"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 FDA is encouraging the public to provide comments on the guidance within 60 days to ensure the agency considers them.


FDA issues first draft guidance on clinical trials with psychedelic drugs. News release. US Food and Drug Administration. June 23, 2023. Accessed June 28, 2023.

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