As of March 2017, six participants have received marijuana (cannabis) provided by the National Institute on Drug Abuse (NIDA) in the ongoing Phase 2 clinical trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) at the Scottsdale Research Institute (SRI) in Phoenix, Arizona. MAPS is testing the safety and efficacy of four different potencies of smoked NIDA cannabis to manage symptoms of chronic, treatment-resistant post-traumatic stress disorder (PTSD) in 76 veterans in a placebo-controlled clinical trial.
Dr. Sue Sisley at SRI is actively recruiting U.S. military veterans in the Phoenix area. For more information, visit maps.org/participate/participate-in-research.
The initiation of this trial is a remarkable milestone, as MAPS first submitted their Investigational New Drug application to the FDA in November of 2010. Over the past seven years the study encountered numerous setbacks in gaining approvals from regulatory agencies, however, the research team was able to overcome all these obstacles, beginning screening in January of 2017. Enrollment for participation in the study is ongoing, and expected to last through February 2018 in Phoenix, Arizona. Data are expected to be available in January 2019.
Previously, the clinical trial was a multi-center study at both Johns Hopkins University (JHU) in Baltimore, Maryland, and at SRI in Arizona. Recently, JHU elected no longer to participate in the trial to focus on other research projects.
MAPS’ clinical research focus is the drug development of whole plant marijuana. The goal is to turn whole plant marijuana into a prescription medication approved by the FDA that would be covered by insurance companies. At this time, the Drug Enforcement Administration (DEA) has yet to issue a Schedule I facility a license to produce cannabis for use in Phase 3 clinical trials, thus preventing drug development research from moving forward.
As MAPS is committed to ensuring the safety of study participants, the study was slightly delayed due to testing and analyzing of the cannabis being used in the clinical trial. Prior to initiating enrollment in the study, laboratory testing of the NIDA cannabis was conducted over five months. All test results were reviewed by an independent Institutional Review Board (IRB). Testing showed an absence of harmful microbes and mycotoxins, and the amount of possible lead exposure from NIDA cannabis is well within available guidelines. After consultation with plant experts, the study team, and medical monitors, MAPS concluded that the cannabis is safe for use in this clinical trial based on exposure limits and dispensation procedures. For full test results, see our official statement at maps.org.
This 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 MAPS, which is sponsoring the research. MAPS is committed to sponsoring rigorous clinical research to develop cannabis into a prescription medicine through the Food and Drug Administration (FDA).