The United States Drug Enforcement Agency (DEA) has granted approval to clinical trials assessing the therapeutic use of medical marijuana to treat Post Traumatic Stress Disorder (PTSD) among US veterans, the non-profit group behind the study said in a press release on Thursday.
The double-blind, placebo-controlled trial will test medical marijuana’s potential benefits on 76 U.S. military veterans with treatment-resistant PTSD, evaluating the efficacy of marijuana strains with different levels of THC and CBD, as well as effective doses and potential side effects. A $2 million grant from Colorado Department of Public Health and Environment will fund the research.
The group behind the groundbreaking research, the Multidisciplinary Approach to Psychedelic Studies (MAPS), says the DEA’s approval marks the first time a clinical trial aiming to turn “smoked botanical marijuana” into a legal prescription drug has received total approval from US regulatory agencies, such as the DEA and Food and Drug Administration.
MAPS celebrated the news in their Thursday announcement.
“We have been working towards approval since we opened the Investigational New Drug Application (IND) with the FDA in 2010,” Amy Emerson, Executive Director and Director of Clinical Research for the MAPS Public Benefit Corporation, said in the press release, “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 announcement follows heightened interest marijuana’s potential therapeutic benefit for veterans with PTSD, including a letter a bipartisan group of US legislators sent to the US Department of Veterans Affairs in January, urging them to allow its physicians to recommend medical marijuana to patients.