After years of delays, researchers are set to move forward on a landmark clinical trial meant to evaluate the efficacy of smoked medical marijuana to treat post-traumatic stress disorder (PTSD) in military veterans. The study is being funded with tax revenue from legal cannabis sales in Michigan.
The Multidisciplinary Association for Psychedelic Studies, or MAPS, announced this week that the U.S. Food and Drug Administration (FDA) granted approval for Phase 2 of the research, what MAPS described in a press release as “a randomized, placebo-controlled study of 320 Veterans suffering from moderate to severe PTSD who have previously used cannabis.”
The group said the study “is designed to investigate the inhalation of high THC dried cannabis flower, versus placebo cannabis, with the daily dose being self-titrated by participants.” It’s meant to reflect consumption patterns already happening across the country and study “the ‘real-world’ use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.”
The project is years in the making, MAPS said, noting that it encountered numerous issues in clearing the research with FDA that only recently were resolved.
“After 3 years of negotiations with the FDA, this decision opens the door to future research into cannabis as a medical treatment, offering hope to millions,” the organization said.
“These data are critical to inform patients, medical providers, and adult-use consumers when considering cannabis in treatment plans for the management of PTSD, pain, and other serious health conditions,” the group’s press release said, “yet regulatory obstacles have historically made it difficult or impossible to conduct meaningful research on the safety and effectiveness of cannabis products typically consumed in regulated markets.”
MAPS said that over the years, it responded to five partial clinical hold letters from FDA that halted the study’s progress.
“On August 23, 2024, MAPS responded to the FDA’s fifth clinical hold letter by submitting a Formal Dispute Resolution Request (FDRR) to resolve the continued scientific and regulatory disagreement with the Division on four key issues,” according to the organization: “1) the proposed THC dose of the cannabis flower product, 2) smoking as a delivery method, 3) vaping as a delivery method, and 4) the enrollment of cannabis naïve participants.”
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