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First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs
The FDA published its first draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.1 In the guidance, the FDA says the term psychedelic includes classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).2
Psychedelics have been evaluated as therapies for a number of conditions including depression, post-traumatic stress disorder, and substance use disorders. The challenges associated with designing clinical studies to evaluate the safety and effectiveness psychedelics is why FDA issued the guidance.
“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 at CDER.1
For example, the guidance states, psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations, creating a potential for abuse of these drugs. This drug safety issue requires careful consideration to put in place sufficient measures to prevent misuse throughout clinical development. For psychedelics that are currently Schedule I controlled substances, the draft guidance notes that activities associated with investigations under an IND must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements.2
The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing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.2
The FDA is accepting public comments on the draft guidance for 60 days.1 Currently, there are there are 163 Phase I, II or III interventional studies recruiting and/or active on clinicaltrials.gov using the search term psychedelics.3
1. FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs. FDA NEWS RELEASE, June 23, 2023.
2. Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry DRAFT GUIDANCE, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), June 2023 Clinical/Medical.
3. Clinicaltrials.gov. 163 Studies found for: psychedelics, Not yet recruiting, Active, not recruiting, Interventional Studies, Adult, Older Adult, Phase I, II, III. Accessed June 25, 2023.