The Multidisciplinary Affiliation for Psychedelic Research (MAPS) has decided on Changemark Analysis + Analysis because the contract analysis group for its long-awaited Section 2 trial of smoked hashish for the remedy of PTSD in U.S. veterans. The ladies-owned and women-led company will information web page variety and recruitment, with projections pointing to the primary player starting remedy in early 2026.
The find out about, referred to as MJP2, is funded by way of a $12.9 million grant from the Michigan Veteran Marijuana Analysis Grant Program. It’ll sign up 320 veterans with average to serious PTSD and generate medical knowledge that displays real-world hashish use.
Clearing the FDA roadblock
This milestone follows MAPS’ victory in a three-year dispute with the U.S. Meals and Drug Management, which had saved the find out about on partial dangle since 2021. In November 2024, after a chain of 5 medical dangle letters, MAPS secured clearance to continue with smoking and self-titration of hashish flower with THC efficiency ranges that fit what’s to be had in felony markets.
The FDA additionally agreed to permit vaporization in theory, although it asked further knowledge on particular units. One restriction stays: contributors will have to have already got prior enjoy breathing in hashish, apart from those that are cannabis-naïve.
Rick Doblin, Ph.D., MAPS’ founder and president, stated the group refused to compromise on find out about design to be able to mirror how other folks in reality devour hashish. “We spent years difficult the FDA, and also have the fitting spouse to hold it ahead,” Doblin famous.
Why veterans subject
Veterans are on the middle of this trial. PTSD stays a number one well being disaster amongst former carrier participants, with suicide charges a long way upper than the overall inhabitants. Many veterans have lengthy reported that hashish supplies aid the place prescribed drugs fall brief.
Sue Sisley, M.D., major investigator of MJP2, underscored the urgency: “Veteran sufferers have shared how smoking hashish helped them arrange their PTSD signs greater than conventional prescribed drugs. Suicide amongst veterans is an pressing public well being disaster, however it’s solvable if we spend money on researching new therapies.”
A brand new more or less spouse
Changemark brings deep enjoy in substance use and psychological well being analysis, together with trials with hashish, MDMA, psilocybin, ibogaine, and ketamine. The corporate additionally operates with an explicitly anti-prohibition stance, aligning its values with MAPS’ decades-long challenge to amplify get right of entry to to evidence-based care.
“MAPS has lengthy stood at the vanguard of study and advocacy to dismantle out of date obstacles to care,” stated Jill Fikowski, Changemark’s founder and CEO. “The selection to spouse with Changemark in this trial alerts consider in each our features and our values. We take that consider significantly.”
What comes subsequent
With web page variety and recruitment underway, MJP2 is predicted to start enrolling veterans in Michigan and two further states within the first quarter of 2026. Effects from the trial may after all supply the type of high quality, managed knowledge that clinical suppliers, regulators, and sufferers have sought for many years.
For MAPS, the trial marks a go back to hashish after years of main the worldwide dialog round psychedelic-assisted remedy. For veterans, it represents an opportunity to validate what many already know: that hashish is usually a lifeline.
Photograph by way of Ryan Stone on Unsplash
