Feds Weigh In on Psychedelic Medicine Clinical Trials

By Jonathan Springston, Editor, Relias Media

Acknowledging the expanding interest in investigating the possible therapeutic benefits of psychedelic medicine, the FDA has issued its first draft guidance to help researchers design clinical trials appropriately.

“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, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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.”

The agency defined “classic psychedelics” that have drawn much interest, such as psilocybin (found in “magic mushrooms”), lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA). The guidance authors noted that although there is therapeutic potential, researchers should remain cautious about side effects (e.g., “intense perceptual disturbances and alterations in consciousness that can last for several hours”).

The draft guidance is non-binding; rather, the authors offered some tips regarding trial conduct, data collection, subject safety, and new drug application requirements. “Because this is an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,” the authors wrote. “Rather than providing specific recommendations on study design, this guidance will present foundational constructs that all sponsors, including academic sponsor-investigators, studying the therapeutic potential of psychedelic drugs should consider.”

The FDA announced the draft guidance two days after Congress requested the agency do so. A coalition of bipartisan lawmakers and other advocacy groups, led by Rep. Dan Crenshaw, R-TX, have rallied around federal legislation called the Douglas 'Mike' Day Psychedelic Therapy to Save Lives Act. Named after a Navy SEAL who took his own life earlier this year, this legislation would direct the Secretary of Defense to “award grants to eligible entities to conduct research on the treatment of members of the armed forces serving on active duty with a covered condition using covered psychedelic substances.”

Crenshaw, a retired Navy SEAL, is a believer in using psychedelic medicine to treat PTSD and traumatic brain injuries in veterans. The congressman has been barnstorming in June, explaining why the Save Lives Act is important during a press conference on Capitol Hill and offering more details about his positions on psychedelic medicine during testimony before the House Committee on Energy and Commerce.

Meanwhile, voters in Oregon and Colorado have approved ballot measures legalizing psilocybin and establishing regulatory frameworks. Lawmakers in other states are considering similar proposals.

The FDA is accepting public comments on its draft guidance until Aug. 25.

For more on this and related subjects, be sure to read the latest issues of Integrative Medicine Alert and Medical Ethics Advisor.