By Morgan Fox
On Thursday, the
The U.S. Drug Enforcement Administration (DEA) has formally approved the first-ever randomized controlled trial of whole plant medical marijuana (cannabis) as a treatment for posttraumatic stress disorder (PTSD) in U.S. veterans. The DEA’s approval marks the first time a clinical trial intended to develop smoked botanical marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies, including the DEA and the Food and Drug Administration (FDA).
The randomized, blinded, placebo-controlled study will test the safety and efficacy of botanical marijuana in 76 U.S. military veterans with treatment-resistant PTSD. The study is funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE) to the California-based non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the research.
The trial will gather safety and efficacy data on four potencies of smoked marijuana with varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD). By exploring the effectiveness of a variety of marijuana strains, the study seeks to generate naturalistic data comparable to how many veterans in medical marijuana states currently use marijuana. Results will provide vital information on marijuana dosing, composition, side effects, and areas of benefit to clinicians and legislators considering marijuana as a treatment for PTSD.
Congratulations and thanks go to Dr. Sue Sisley, who has long been the foremost champion of studying the effects of marijuana on PTSD, and the rest of the staff at MAPS for working so diligently in this area.
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