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FDA Creates Guidance for Psychedelic Drug Trials

'Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,' said an official

FDA Creates Guidance for Psychedelic Drug Trials

The Food and Drug Administration is laying the groundwork for clinical trials of psychedelic drugs.

The government regulatory agency released a new draft guidance for those designing trials for such substances. Some researchers believe psychedelic drugs could be used to treat a number of health concerns including depression, substance use disorder and post-traumatic stress disorder.

“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 Dr. Tiffany Farchione, the director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a press release. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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 FDA warned that there are a “number of unique challenges that require careful consideration” when designing a clinical trial for psychedelic treatments.

The draft guidance is intended to advise researchers as they design the trials, detailing “trial conduct, data collection, subject safety and new drug application requirements.” The FDA specifically expresses concern about a “potential for abuse” as the drugs “may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations.”

Additionally, “the draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect,” notes the agency.

The draft guidance is open for comments from the public, which can be submitted to the FDA for 60 days after its release. 

The release follows a bipartisan push led by Congressman Dan Crenshaw, a Republican from Texas, to open the door to federally funded research into the benefits and uses of psychedelics.

Crenshaw and ten other representatives co-signed a letter in April urging the National Institutes of Health to include active-duty service members in studies on psychedelics.

“As the largest public funder of biomedical research in the world, this directive for the NIH would expand government wide efforts to understand the potential risks and benefits of psychedelic-assisted therapy to this critical population,” the representatives wrote. “We need new approaches to adequately address the threat of trauma-related disorders and chronic pain to both active-duty and veteran servicemembers. Our men and women in uniform are disproportionately impacted by these disorders, and a recent NIH-funded study found that post-traumatic stress disorder (PTSD) had an incidence rate of nearly 13% in the active-duty military population.”

On May 25, Crenshaw introduced the Douglas “Mike” Day Psychedelic Therapy to Save Lives Act which would establish a $75 million grant program for research into therapeutic treatment for PTSD, including investigating the potential use of psychedelics. 

“All this does is direct the Department of Defense to begin the research and allow service members to keep their status if they participate in those trials. It is a simple but very positive step in the right direction,” he said during a press conference on June 14, per Stars and Stripes.

The bill, which passed the House in 2022 but failed in the Senate, is supported by a coalition of lawmakers, including Representatives Alexandria Ocasio-Cortez of New York and Matt Gaetz of Florida,  

Most research into the medicinal benefits of psychedelics has been privately funded.

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