The US Food and Drug Administration (FDA) has finally approved a Phase 2 clinical trial into cannabis in treatment of post-traumatic stress disorder (PTSD), three years after being put on hold.
Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and funded by a $12.9 million grant from the Michigan Veteran Marijuana Research Grant Program, ‘MJP2’ will explore the effectiveness of inhaled THC dried cannabis flower to treat the pervasive condition.
MJP2 will include 320 veterans with moderate-to-severe PTSD, who have previously used cannabis, aiming to assess the safety and efficacy of inhaled high-THC cannabis flower in comparison with a placebo.
Each participant will now be able to ‘self-titrate’, meaning they can select their own dosage with a THC potency that aligns with what is commercially available in legalized states.
Its predecessor, MJP1, showed that inhaled cannabis (high THC, high cannabidiol, and a combination of both) improved PTSD symptoms, including anxiety, depression, and sleep quality, in 76 veterans with chronic PTSD, helping guide the design of MJP2.
However, dispite these early results, the FDA blocked MJP2 from taking place in 2021, and it has been in hold ever since.
The FDA stalled the trial due to safety concerns regarding inhaled, high-THC cannabis and the self-dosing method, which it has now greenlit.
Furthermore, the agency also no longer objects to the use of vaporization as a delivery method, although additional safety assessments are required for the device.
Following a Formal Dispute Resolution Request (FDRR) and continued pressure from MAPS, the FDA has resolved these issues, paving the way for the study’s commencement.
MAPS founder and president, Rick Doblin, Ph.D., said of the news: “MAPS takes pride in leading the way to open new research pathways by challenging the FDA to think differently. We debated with the FDA for more than 15 years to be able to conduct rigorous research for MDMA-assisted therapy for PTSD, a novel treatment approach for FDA reviewers, then and now.
“Similarly, our cannabis work challenges FDA’s typical approach to scheduled dosing and administration of drugs. MAPS refused to compromise the study design in order to fit into the standard box of FDA thinking in order to ensure that cannabis research reflects cannabis use.”
According to the study’s Principal Investigator, Sue Sisley, M.D., this study will go a long way towards addressing the growing needs of veterans.
“MJP2 will generate data that doctors, like myself, can use to develop treatment plans to help people manage their PTSD symptoms.”
