For the first time ever, the DEA has approved of a study that will examine cannabis and its potential in the treatment of Post Traumatic Stress Disorder (PTSD).
Both the DEA and the FDA will oversee the study, which is being funded by the Colorado Department of Public Health and Environment (CDPHE) and the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit based in California. The double-blind study will be placebo-controlled, and will look for a correlation between the use of marijuana and the reduction in PTSD symptoms in 76 selected veterans. Four different ratios of THC and CBD will be used in different strengths, providing researchers with a comprehensive amount of data to analyze.
“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,”
MAPS said in a statement.
Approximately 22 million veterans suffer from Post Traumatic Stress Disorder, according to the National Institute of Health. Conventional treatments for PTSD have inconsistent success rates, which often leads patients to self-medicate. About 20 percent of veterans with PTSD also suffer from substance abuse, which includes prescription drugs, alcohol and opioids.
While veterans have been advocating for marijuana as a possible treatment option for PTSD, its Schedule I status with the DEA means physicians within the Veterans Administration are prohibited from prescribing it. Veterans who test positive for illegal substances, including cannabis, can lose their access to VA medical services and other benefits. Recently, the CDC urged physicians to stop testing for marijuana and disqualifying patients with positive test results, as it can lead to an unjustified reduction in patient care. Research efforts are also hampered by federal prohibition, which makes the approval of this study a victory for medical marijuana advocates.
“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,” said executive director of clinical research for MAPS Amy Emerson.
Twenty-four states and Washington D.C. have medical marijuana programs, with other states pushing for their own programs. Cannabis is still prohibited under federal law, but the DEA assured lawmakers in April that it will consider rescheduling marijuana after a plea by Elizabeth Warren and other senators to reconsider its potential in treating acute medical conditions.