FDA Approves Cannabis Trial For Veterans With PTSD After Years Of Delays

After years of regulatory delays, the U.S. Food and Drug Administration (FDA) has approved Phase 2 of a clinical trial to assess the efficacy of smoked medical cannabis in treating post-traumatic stress disorder (PTSD) among military veterans.

Funded by Michigan's Veteran Marijuana Research Grant Program, the study is poised to be a critical step in understanding how cannabis impacts PTSD symptoms, Marijuana Moment reported.

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The trial, spearheaded by the Multidisciplinary Association for Psychedelic Studies (MAPS), will be a randomized, placebo-controlled investigation involving 320 veterans diagnosed with moderate to severe PTSD.

Participants will self-titrate doses of high-THC cannabis flower or a placebo, mirroring real-world consumption patterns. MAPS aims to evaluate both the benefits and risks of inhaled cannabis for PTSD treatment.

A Long Road To Approval

The FDA's approval comes after a protracted process marked by five partial clinical hold letters that temporarily stalled the study. MAPS responded to the final hold in August 2024 with a Formal Dispute Resolution Request (FDRR), challenging the FDA on several issues, including concerns over THC dosage, smoking as a delivery method and enrolling cannabis-naïve participants.

"After three years of negotiations with the FDA, this decision opens the door to future research into cannabis as a medical treatment, offering hope to millions," MAPS said in a statement.

MAPS principal investigator Dr. Sue Sisley said, "In the absence of high-quality data related to cannabis, much of the information available to patients and regulators is rooted in prohibition and focused only on potential risks, without consideration of potential benefits."

Funding And Future Implications

The Michigan program funding the trial uses tax revenue from legal cannabis sales, mirroring a growing trend of states leveraging marijuana taxes to support medical research. In 2021, Michigan allocated $13 million to MAPS for this study, with additional funds directed toward other cannabis-related research initiatives.

"Veterans are in dire need of treatments that can ease their challenging symptoms of PTSD,” stated Rick Doblin, founder and president of MAPS. “This study will generate data that doctors, like myself, can use to develop treatment plans to help people manage their PTSD symptoms."

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