The Multidisciplinary Association for Psychedelic Studies (MAPS) has selected Changemark Research + Evaluation as the contract research organization for its long-awaited Phase 2 trial of smoked cannabis for the treatment of PTSD in U.S. veterans. The women-owned and women-led firm will guide site selection and recruitment, with projections pointing to the first participant beginning treatment in early 2026.
The study, known as MJP2, is funded by a $12.9 million grant from the Michigan Veteran Marijuana Research Grant Program. It will enroll 320 veterans with moderate to severe PTSD and generate clinical data that reflects real-world cannabis use.
Clearing the FDA roadblock
This milestone follows MAPS’ victory in a three-year dispute with the U.S. Food and Drug Administration, which had kept the study on partial hold since 2021. In November 2024, after a series of five clinical hold letters, MAPS secured clearance to proceed with smoking and self-titration of cannabis flower with THC potency levels that match what is available in legal markets.
The FDA also agreed to allow vaporization in principle, though it requested additional data on specific devices. One restriction remains: participants must already have prior experience inhaling cannabis, excluding those who are cannabis-naïve.
Rick Doblin, Ph.D., MAPS’ founder and president, said the organization refused to compromise on study design in order to reflect how people actually consume cannabis. “We spent years challenging the FDA, and now have the right partner to carry it forward,” Doblin noted.
Why veterans matter
Veterans are at the center of this trial. PTSD remains a leading health crisis among former service members, with suicide rates far higher than the general population. Many veterans have long reported that cannabis provides relief where pharmaceuticals fall short.
Sue Sisley, M.D., principal investigator of MJP2, underscored the urgency: “Veteran patients have shared how smoking cannabis helped them manage their …
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Author: Javier Hasse / High Times
