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Dr Marie Sartain
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FDA issues first guidance for clinical trials with psychedelics

FDA has issued new draft guidance geared toward industry regarding considerations for designing clinical trials involving psychedelic drugs.

“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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,” said Tiffany Farchione, MD, director of the Division of Psychiatry in FDA’s Center for Drug Evaluation and Research, in a news release.

The draft guidance uses the term ‘psychedelics’ to refer to “classic psychedelics” such as psilocybin, LSD, and entactogens/empathogens such as MDMA.

The document notes that psychedelic drugs may generate psychoactive effects such as hallucinations, cognitive changes, and mood changes, so there is a potential for misuse.

This poses a drug safety issue that calls for implementing adequate safety measures throughout clinical development. For psychedelics that are currently Schedule I controlled substances, the draft guidance points out that activities associated with investigations under an Investigational New Drug Application must comply with applicable DEA regulatory requirements.

The guidance also notes that while the evidentiary standard for determining the effectiveness of psychedelic drugs is the same as for all other drugs, there are distinct elements that researchers may need to consider when forming their clinical trials to ensure those trials are regarded as sufficiently well-controlled. The draft guidance also examines the effect of psychotherapy in psychedelic drug development, considerations for safety monitoring, the need to characterize dose-response, and the durability of any treatment effect.

FDA is encouraging the public to submit comments on the draft guidance.

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