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.
"We have been working towards approval since we opened the Investigational New Drug Application (IND) with the FDA in 2010," says Amy Emerson, Executive Director and Director of Clinical Research for the MAPS Public Benefit Corporation. "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."
Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania's Perelman School of Medicine, will oversee the two separate sites as Coordinating Principal Investigator (PI). Half of the subjects will be treated by Co-Investigator/Site PI Sue Sisley, M.D., in Phoenix, AZ, and the other half by Co-Investigator/Site PI Ryan Vandrey, Ph.D., at Johns Hopkins University in Baltimore, MD. Co-Investigator Paula Riggs, M.D., of the University of Colorado School of Medicine, will oversee the scientific integrity of the study. Blood analysis will be conducted at the University of Colorado, Boulder. MAPS will work with the FDA to manage and monitor data, oversee drug accountability, and ensure that the study follows Good Clinical Practice guidelines.
Since its founding in 1986, MAPS has raised over $36 million for psychedelic therapy and medical marijuana research and education. MAPS is working to evaluate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses approved by the FDA.