Tuesday, June 27, 2023

FDA Issues Draft Guidance for Conducting Clinical Trials With Psychedelic Substances

The Food and Drug Administration (FDA) has for the first time issued draft guidance on conducting clinical trials with psychedelic substances such as psilocybin and MDMA (ecstasy).

“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, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in an agency press release.

She added that the guidance outlines some of the unique challenges inherent in designing psychedelic-based clinical trials and should help researchers design studies whose results can support future drug applications.

These are among the many clinical items discussed in the draft guidance:

  1. A reminder that psychedelics are still Schedule I controlled substances reflecting a potential for misuse and abuse. Clinical trial researchers should carefully assess and monitor all abuse-related adverse events such as euphoria, hallucinations, and rapid mood swings.
  2. The need to clearly describe the experiential changes brought on by these drugs during the informed consent process, such as changes in perception, cognition, and suggestibility that can last for several hours.
  3. The importance of carefully observing participants during the entire psychedelic-assisted psychotherapy session. The FDA recommends at least two monitors, with the lead monitor having graduate-level training and clinical experience with psychotherapy.

The FDA guidance further discusses issues related to the manufacture of research psychedelics and conducting preclinical chemistry studies. The FDA recognizes the difficulties in finding suitable placebos for psychedelics and the high risk of bias given the very noticeable changes brought on by these drugs, but it stated in the release that the “evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs.”

The FDA invites professional feedback to the draft guidance by August 25 to ensure consideration.

To read more on this topic, see the Psychiatric News article “Psychedelics Legislation Gains Momentum” and the Psychiatric Services article “Ethical and Practical Considerations for the Use of Psychedelics in Psychiatry.”

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