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 drug addiction are common among Veterans and significant drivers of suicidality.
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 drug addiction. 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.
MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, previously organized the only U.S. Food and Drug Administration (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 consumers. 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 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.
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.
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 MAPS, a 501(c)(3) non-profit organization.
This was reported by Multidisciplinary Association for Psychedelic Studies on August 10, 2021.
Contact information: Betty Aldworth, Director of Communications, Multidisciplinary Association for Psychedelic Studies, 3141 Stevens Creek Boulevard, #40563, San Jose, California 95117; 831-429-6362, ext. 303; Email: email@example.com/; Website: https://maps.org/