The California-based non-profit Multidisciplinary Association for Psychedelic Studies has been awarded a $2.156 million grant to test the effectiveness of marijuana as a post-traumatic stress disorder treatment. The study has been approved by the Drug Enforcement Agency and the Food and Drug Administration, marking the first time federal agencies have approved a trial involving smoking “botanical” marijuana, according to a MAPS press release.
The study, funded by the Colorado Department of Public Health, will test the efficiency and safety of flower cannabis as an option to help veterans manage treatment-resistant PTSD. Seventy-six U.S. military veterans will participate in the randomized, triple-blind, placebo-controlled study.
“We have been working towards approval since we opened the Investigational New Drug Application with the FDA in 2010,” Amy Emerson, executive director and director of clinical Research for the MAPS Public Benefit Corporation, said. “We are thrilled to see this study overcome the hurdles of approval so we can begin gathering the data. This study is a critical step in moving our botanical drug development program forward at the federal level to gather information on the dosing, risks, and benefits of smoked marijuana for PTSD symptoms.”
The trial will gather data on four potencies of smoked marijuana with different ratios of THC and CBD. Researchers expect to gain information on dosing, composition, and side effects.
According to MAPS’ final protocol study, it is estimated that 18 percent of Operation Iraqi Freedom veterans suffer from PTSD and another 75,000 to 225,000 service members will return from duty with symptoms.