- Phase 2 clinical trial will compare the safety and efficacy of self-titrated high-THC cannabis against placebo for treatment of PTSD among Veterans
- Second clinical trial of inhaled botanical cannabis is expected to substantially contribute to body of evidence regarding cannabis as a medicine for PTSD
- If positive results are achieved, Phase 3 trials will be conducted to support development of a prescribable inhaled cannabis medication eligible for insurance coverage
The Multidisciplinary Association for Psychedelic Studies (MAPS) has been awarded a $12,979,050 grant from Michigan’s $20 million competitive 2021 Veteran Marijuana Research Grant Program. The program, which is funded by adult-use marijuana retail taxes, is designed to evaluate “the efficacy of marijuana in treating the medical conditions of United States armed services veterans and preventing veteran suicide.” Posttraumatic stress disorder (PTSD), depression, and substance use disorders are common among Veterans and significant drivers of suicidality.
“Suicide among Veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments for pain, depression, and PTSD,” said Sue Sisley, M.D., President of Scottsdale Research Institute and renowned cannabis specialist. “This grant enables more rigorous study, overseen by the FDA, which may lead to cannabis flower becoming prescribable medicine someday. Veterans are demanding objective cannabis drug development research, and the state of Michigan is fulfilling our collective obligation to our beloved Veteran community.”
“We overcame significant regulatory obstacles obstructing cannabis research to conduct the first clinical trial of inhaled cannabis for PTSD,” said Berra Yazar-Klosinki, Ph.D., Chief Scientific Officer of MAPS Public Benefit Corporation (MAPS PBC). “This grant funding provides the resources needed to leverage the results from the first trial, conduct a fully-powered clinical trial, and align the body of scientific evidence with cannabis that more closely mirrors what is available within state-regulated cannabis programs.”
The newly-funded study will be only the second clinical trial to compare the safety and efficacy of cannabis against placebo for treatment of PTSD and the first to evaluate inhalation of high-THC botanical cannabis. Veterans who have been diagnosed with moderate-to-severe PTSD will be eligible for enrollment; the trial will not exclude those with major depressive disorder or substance use disorders. Three hundred twenty Veterans will be enrolled across four trial sites, two of which will be in Michigan. Following a three-week enrollment and evaluation period, Veterans will spend five weeks self-administering inhaled, self-titrated doses of high-quality botanical cannabis on an outpatient basis for treatment of PTSD.
Rick Doblin, Ph. D,, Founder and Executive Director of MAPS, celebrated “this tremendous use of marijuana taxes. Michiganders are granting non-profit researchers the opportunity to establish whether marijuana is helpful for Veterans with PTSD. If so, we will seek to return that generosity by developing a public-benefit cannabis pharmaceutical product that would be eligible for insurance coverage, just like any other pharmaceutical drug.”
MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, previously organized the only FDA-regulated controlled study of cannabis for PTSD, funded with a $2.2 million grant from the Colorado Department of Public Health and Environment and conducted at the Scottsdale Research Institute. The study provided a more thorough understanding of the potential risks and benefits of cannabis as a treatment for PTSD with all treatment groups showing good tolerability and improvements in PTSD symptoms after three weeks. It further informed the development of this second, larger trial, identifying that higher quality cannabis must be used to differentiate between response of the control group and placebo group.
This study will continue MAPS’ investigation into the treatment of PTSD with the second randomized controlled trial (RCT) to test the therapeutic potential of inhalation of botanical cannabis as a treatment for PTSD in U.S. Veterans. This study is essential for understanding potential risks and therapeutic benefits of cannabis for PTSD patients. The study protocol has been submitted to and reviewed by the U.S. FDA, with some minor methodological design elements still under discussion. Unlike observational studies, which are not FDA or DEA-regulated or approved, this study is an FDA and DEA-regulated double-blind, placebo-controlled RCT sponsored by a non-profit organization using federally legal cannabis. This study is following all applicable regulations to obtain FDA approval for prescription use of cannabis in order to provide federally legal access to cannabis for Veterans who are at risk for suicide, as stipulated by the law that defines this grant opportunity, with insurance eligibility after potential FDA approval.
Betty Aldworth, Director of Communications
maps.org/newsroom or email@example.com
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Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education and has earned the Guidestar Platinum Seal of Transparency.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.