PRESS RELEASE: First Clinical Trial of Marijuana for PTSD in Veterans Nearly Completes Enrollment
PHOENIX, ARIZ.—Today, researchers announced that the first randomized controlled trial of whole plant (botanical) 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. Despite the refusal of the U.S Department of Veterans Affairs and Arizona’s public universities and hospitals to assist with recruitment for the study, the trial is on track to finish on time.
“We are elated to finally be in the home stretch of this controlled trial that began its journey over 10 years ago,” says 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 physicians, 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.
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.
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.”
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $47 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS formed in 2015 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapsbcorp.com.
Scottsdale Research Institute (SRI) is a Phoenix-based clinical trials site that is dedicated to advancing the state of medical care through rigorous research. SRI strives to conduct high quality, controlled scientific studies intended to ascertain the general medical safety and efficacy of cannabis and cannabis products and examine various forms of cannabis administration. For more information, visit sriresearch.org.