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FDA Clears MAPS Veteran PTSD Cannabis Study
The Multidisciplinary Association for Psychedelic Studies (MAPS) has taken a major step forward in advancing cannabis research for veterans with PTSD. Partnering with Changemark Research + Evaluation, a women-owned and women-led research firm, MAPS is launching its long-awaited Phase 2 trial on smoked cannabis for U.S. veterans. Known as MJP2, the trial is backed by a $12.9 million grant from the Michigan Veteran Marijuana Research Grant Program and will enroll 320 participants beginning in early 2026.
Overcoming the FDA Hurdle
This milestone follows MAPS' resolution of a three-year standoff with the FDA. Since 2021, the study had been on partial clinical hold due to concerns raised by the agency. MAPS received five separate hold letters before finally gaining clearance in November 2024. The FDA ultimately approved the study's design, which allows participants to smoke and self-titrate cannabis flower with THC potency levels that reflect real-world use.
In a key concession, the FDA also approved vaporization in principle but requested more data on specific devices. However, one stipulation remains: participants must already have prior experience inhaling cannabis. This condition excludes cannabis-naïve individuals but ensures that enrolled veterans can tolerate the study protocols.
Rick Doblin, Ph.D., founder and president of MAPS, noted that the organization refused to compromise on study design. "We spent years challenging the FDA, and now we have the right partner to carry it forward," he said.
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