Core One Labs Inc. commends the U.S. Food and Drug Administration (FDA) for publishing a new draft guidance on clinical trials for psychedelic drugs. The FDA's draft guidance underscores the crucial considerations that researchers must address when exploring the potential therapeutic applications of psychedelic drugs in treating various medical conditions, including psychiatric and substance use disorders. Importantly, this is the first FDA draft guidance providing instructions to the industry for designing clinical trials for psychedelic drugs.

In recent years, there has been a growing interest in the potential therapeutic benefits of psychedelic drugs. These compounds are being investigated for their ability to treat conditions such as depression, post-traumatic stress disorder (PTSD), substance use disorders, and others. However, designing clinical studies to evaluate the safety and efficacy of these compounds presents unique challenges that demand careful attention.

The draft guidance aims to provide valuable advice to researchers on study design and other critical considerations as they develop medications containing psychedelics. It specifically focuses on " classic psychedelics," such as psilocybin and lysergic acid diethylamide (LSD), which act on the brain's serotonin system, as well as "entactogens" or "empathogens" like methylenedioxymethamphetamine (MDMA). Throughout the document, the FDA outlines fundamental considerations for the drug development process, including trial conduct, data collection, subject safety, and new drug application requirements.

Notably, psychedelic drugs can produce psychoactive effects, including mood and cognitive changes and hallucinations. Consequently, preventing misuse and ensuring drug safety necessitate meticulous planning and the implementation of appropriate safety measures during clinical development. For psychedelics currently categorized as Schedule I controlled substances, the draft guidance emphasizes compliance with relevant Drug Enforcement Administration regulatory requirements during activities associated with investigations under an Investigational New Drug Application.

The evidentiary standard for establishing the effectiveness of psychedelic drugs is the same as that for all other drugs. However, investigators need to consider unique factors when designing their clinical trials to ensure they meet the criteria for being deemed adequate and well-controlled. The draft guidance also addresses the role of psychotherapy in psychedelic drug development, safety monitoring considerations, and the importance of characterizing dose-response and the durability of any treatment effect.

To foster an inclusive approach, the FDA encourages public participation and invites comments on the draft guidance. Interested parties are encouraged to submit their comments within 60 days to ensure consideration by the agency.