The U.S. Food and Drug Administration (FDA) has published its inaugural draft guidance on clinical trials involving psychedelic drugs (Psychedelic trials). The guidance is designed to provide researchers with key considerations when investigating potential psychedelic treatments for medical conditions, including psychiatric and substance use disorders. This development comes amidst a surge of interest in the therapeutic potential of psychedelic drugs for conditions such as depression, post-traumatic stress disorder (PTSD), and substance use disorders.
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The draft guidance outlines the inherent challenges in psychedelic drug development, manufacturing, safety, and clinical trial conduct. It provides advice on study design, data collection, subject safety, and new drug application requirements. It also addresses the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and the implementation of sufficient safety measures to prevent misuse throughout clinical development.
The draft guidance presents considerations for industry in designing clinical trials for psychedelic drugs, addressing the unique challenges inherent in such studies. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
The term psychedelics in the draft guidance refers to “classic psychedelics” such as psilocybin, a naturally occurring hallucinogenic chemical found in certain mushrooms known as magic mushrooms, and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system. The guidance also includes psychedelics such as 3,4-Methylenedioxymethamphetamine (MDMA), a potent empathogen–entactogen with stimulant properties.
The FDA also focuses on abuse potential assessments and compliance with Drug Enforcement Administration (DEA) regulations. Finally, the FDA outlines considerations that may be unique to clinical trials evaluating psychedelic drugs. For example, adequate and well-controlled (AWC) clinical trials and using a traditional placebo as a control might be “problematic for assessing efficacy”.
The FDA is encouraging the public to provide comments on the draft guidance within 60 days to ensure the agency considers them. This development is a significant step forward in the field of psychedelic research and could pave the way for more robust and comprehensive clinical trials in the future. [Source: FDA]
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