DEA Approves Medical Marijuana Clinical Trial
The Drug Enforcement Agency recently approved a first-ever randomized, placebo-controlled clinical trial to study the use of botanical (“whole plant”) marijuana (rather than an extract made thereof) to treat post-traumatic stress disorder in veterans. DEA’s granting of a Schedule I license for the study allows researchers to purchase research-grade cannabis from the National Institute on Drug Abuse for use in conducting the trial. Although FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies.
The study is being sponsored by the California-based non-profit Multidisciplinary Association for Psychedelic Studies and is largely being financed by a $2 million grant from the Colorado Department of Public Health. Researchers plan to test a variety of cannabis strains at varying dosage levels to help determine optimal dosing for achieving a therapeutic benefit related to PTSD.
The study is listed in the National Institutes of Health (NIH) clinical trial database, “ClinicalTrials.gov,” and a link to the study can be found here. Study locations will include the Scottsdale Research Institute in Phoenix, AZ and Johns Hopkins University School of Medicine in Baltimore, MD. Participant recruitment for the study is expected to begin in approximately 60 days. Study enrollees must be age 18 or older to be eligible for inclusion.
The DEA’s approval of the study may signal a willingness on the part of the Agency to remove marijuana from Schedule I of the Controlled Substances Act — a category reserved for drugs with a “high potential for abuse” that have “no currently accepted medical use” and are so dangerous that they cannot be used safely, even under medical supervision. As we noted here, DEA is currently evaluating whether to downgrade the classification of marijuana, with a decision expected this summer.
Arent Fox will continue to follow and report on developments involving state and federal regulation of marijuana and related regulatory and safety issues. Please contact James R. Ravitz, Emily M. Leongini, or James H. Hartten for further assistance.