On June 23, 2023, the Food and Drug Administration (FDA) took an important step toward acknowledging the growing interest in psychedelic drugs as potential medical treatments. On this date, they issued their inaugural draft guidance specifically addressing clinical trial designs involving these substances; their purpose being to offer researchers guidance when exploring their therapeutic potential for treating mental and substance use disorders.

Over recent years, psychedelic drugs have gained increasing attention as potential treatments for various conditions including depression, post-traumatic stress disorder (PTSD) and substance abuse disorders. Due to their unique properties, conducting clinical studies evaluating their safety and effectiveness presents several unique challenges that must be carefully taken into account before proceeding with clinical research studies on them.

Dr. Tiffany Farchione, director of Psychiatry within FDA’s Center for Drug Evaluation and Research, highlighted psychedelic drugs’ initial promise as treatments for mood, anxiety, and substance use disorders. However, she reminded that these compounds are still investigational products and sponsors who wish to assess the therapeutic potential of psychedelic drugs must take account of their unique properties when designing clinical studies for these psychedelic medicines. This draft guidance from the FDA seeks to outline the unique challenges associated with designing psychedelic drug development programs and provide advice on how to effectively address them. Researchers should utilize it in designing studies capable of yielding interpretable results that support future applications for drugs.

The draft guidance provides advice to researchers regarding study design and other considerations during the development of medications containing psychedelic substances. It specifically covers “classic psychedelics,” such as psilocybin and Lysergic Acid Diethylamide (LSD) that target serotonin systems; as well as “entactogens,” such as Methylenedioxymethamphetamine (MDMA).

The FDA highlights several key considerations researchers must keep in mind during drug development processes, including trial conduct, data collection, subject safety issues and new drug application requirements. Psychoactive substances, such as psychedelics, may produce psychoactive effects that alter mood and cognition as well as cause hallucinations. Preventing misuse and potential abuse of pharmaceutical drugs is a major safety priority that necessitates implementing robust safety measures throughout clinical development. Draft guidance notes that investigations involving Schedule I controlled substances must comply with applicable Drug Enforcement Administration regulatory requirements when conducted under an Investigational New Drug Application.

Although the evidentiary standard for establishing the efficacy of psychedelic drugs remains the same as for other medications, investigators must take special consideration in designing clinical trials to ensure they are adequate and well-controlled. Furthermore, this draft guidance covers psychotherapy’s role in drug development; safety monitoring considerations; dose response relationships as well as any lasting treatment effects.

To promote public engagement and gather input, the FDA invites comments on its draft guidance within 60 days of release of it for comment. By soliciting feedback, this agency hopes to ensure a wide array of perspectives is considered when finalizing these guidelines.

The Food and Drug Administration, part of the U.S. Department of Health and Human Services, is charged with protecting public health by overseeing human and veterinary pharmaceutical products including vaccines and biological products; medical devices; food supply security; cosmetics/dietary supplement oversight and tobacco product regulation.

Overall, the FDA’s release of its first draft guidance on clinical trials with psychedelic drugs represents an important milestone in acknowledging their therapeutic value. By offering recommendations and outlining considerations unique to psychedelics, they hope to support researchers in designing studies that could lead to safe and efficacious psychedelic treatments for various medical conditions. Inviting public comment ensures a broad array of perspectives will be considered – ultimately creating a collaborative environment in regards to their regulation.

Read the draft here: https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs

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