Researchers announced today that the first randomized controlled trial of whole plant marijuana as a treatment for posttraumatic stress disorder (PTSD) symptoms has nearly completed enrollment, with only seven spaces remaining for U.S. military veterans to volunteer. So far, 69 out of 76 veterans have received treatment in the study.
Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the study is evaluating the safety and effectiveness of smoked marijuana to treat symptoms of PTSD in 76 U.S. veterans.
“We are elated to finally be in the home stretch of this controlled trial that began its journey over 10 years ago,” said researcher Dr. Sue Sisley. “We only have seven spots available for veterans to still be enrolled in the study, but they must be screened before the end of October in order to be eligible. This is their last chance to participate in the first study of cannabis in veterans with PTSD being conducted under FDA guidance.”
The results will provide doctors, patients, scientists, and regulators with critical knowledge regarding whether marijuana benefits individuals with PTSD, whether adverse consequences occur, and the impact of the chemical composition of marijuana, specifically ∆-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), on clinical outcomes. The data from the trial will be finalized in early 2019, after which the results will be prepared for publication.
The study is funded by a $2.156 million grant to MAPS from the Colorado Department of Public Health and Environment, and conducted with approval and oversight from the U.S. Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the National Institute on Drug Abuse (NIDA).
“We are working to complete this trial for the benefit of medical marijuana patients in Colorado, and all across the U.S.,” said MAPS founder and executive director Rick Doblin, Ph.D. “FDA approval of whole plant medical marijuana would mean that patients could have their medical marijuana covered by insurance, although that possibility is currently blocked by the Department of Justice-enforced NIDA monopoly on marijuana for research.”
Participants must be adult military veterans with chronic, treatment-resistant PTSD. Study volunteers will complete 17 outpatient study visits over 12 weeks. Eligibility is determined by medical evaluation. Participants must be able to visit the research site at the Scottsdale Research Institute in Phoenix, Arizona, for all scheduled visits.