The Drug Enforcement Agency has given its blessing to let researchers conduct clinical trials with cannabis to examine the potential benefits of using the plant to treat post-traumatic stress disorder. In what is the first controlled research in the U.S. for PTSD the actual plant will be used instead of oils or synthesized cannabis.
The study will be conducted by the California-based Multidisciplinary Association for Psychedelic Studies (MAPS) with Dr. Sue Sisley at the helm. Sisley, was fired from the University of Arizona in 2014 after complaints about her cannabis-related work by a conservative Republican lawmaker.
“Mostly we’re just grateful that we get to see science move forward,” said Sisley.
While other trials have studied the medical benefits of marijuana and cannabis extracts like cannabidiol, this is the first time regulators have allowed testing of the marijuana plant itself for the purpose of developing it into a legal medical drug. Once the marijuana has been secured, the group will begin recruiting and enrolling participants, perhaps as early as June, MAPS spokesman Brad Burge said.
Blood samples from the study will be analyzed at the University of Colorado, and a professor at CU’s Anschutz Medical Campus will oversee the research’s scientific integrity.
The project is one of nine medical marijuana studies funded by historic grants from Colorado’s Health Department.Colorado in 2014 awarded a $2 million grant to MAPS for the research and at the same time gave an additional $5.6 million to several other organizations to support medical marijuana studies. “The contract with the state of Colorado was signed on 4/20, the unofficial cannabis holiday. “We are now preparing to place the order for the marijuana for the study,” said Burge.
The research first received approval in March 2014 from the Health and Human Services Department and was set to get underway at the University of Arizona and other locations within a year. But the program was delayed after the Tucson, Arizona, school terminated Dr. Sue Sisley’s contract. Sisley, who was then the primary researcher on the program, said she isn’t a medical marijuana activist but believes the nation’s swelling ranks of combat veterans deserve to know whether marijuana works.
“The study needs to happen because these veterans have legitimate questions,” she said.
Marcel Bonn-Miller with the University of Pennsylvania Perelman School of Medicine is now overseeing the project, with Sisley running half the study in Arizona and Ryan Vandrey overseeing the other half at Johns Hopkins University in Baltimore, Maryland.
Participants will include 76 veterans who have treatment-resistant PTSD. The study will use marijuana of various strains and potency for comparison purposes. Sisley said researchers expect to spend the next two years enrolling veterans in the study, perhaps at a rate as slow as four or five veterans per month.
The use of medical marijuana to treat PTSD remains controversial because while some veterans say the plant eases their symptoms and has allowed them to stop using prescription medications, very little scientific research supports these claims.
Advocates say the research will fill a much-needed gap in medical literature.
“We are thrilled to see this study overcome the hurdles of approval so we can begin gathering the data. This 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 Amy Emerson, director of clinical research for the MAPS.
Almost 31 percent of Vietnam veterans, and roughly 20 percent of Iraqi war veterans, suffer from PTSD, according to National Institute of Health.