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.
Why This Matters for Veterans
PTSD continues to be a major public health issue among veterans, with suicide rates significantly higher than in the general population. For many, cannabis has provided relief where traditional pharmaceuticals have failed. Principal investigator Sue Sisley, M.D., emphasized the urgency of the work, noting that countless veterans have already found cannabis beneficial in managing their PTSD symptoms. She highlighted that this FDA-approved study could provide the kind of controlled, clinical evidence that policymakers and medical professionals need.
Changemark’s Role
Changemark brings years of expertise in mental health and substance use trials, with experience in cannabis, MDMA, psilocybin, and ketamine research. Its openly anti-prohibition stance aligns closely with MAPS’ mission. CEO Jill Fikowski explained that being selected by MAPS reflects both confidence in their scientific rigor and alignment in values.
Looking Ahead
With site selection and recruitment already underway, the trial will begin enrolling in Michigan and two additional states in early 2026. For MAPS, this marks a return to cannabis research after years of focusing on psychedelics. For veterans, the trial represents hope and with the FDA finally granting approval, it could deliver the long-awaited data needed to change lives.
