The Food and Drug Administration (FDA) has given the green light to the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization, to initiate clinical trials investigating the effectiveness of smoked cannabis in treating post-traumatic stress disorder (PTSD) among veterans. This Phase 2 study, known as MJP2, marks a significant step towards understanding the potential therapeutic benefits of cannabis for mental health conditions.
The study will involve 320 veterans diagnosed with moderate to severe PTSD. Participants will smoke either active cannabis or a placebo at home and use a mobile app to rate their PTSD symptoms over a five-week period. The trial is designed as a double-blind study, meaning neither the participants nor their clinicians will know which treatment they are receiving. Assessments of PTSD symptoms will be conducted at the beginning and end of the treatment period.
Study Design and Objectives
Veterans selected for the clinical trials must have prior experience smoking cannabis and agree to limit their cannabis use to the doses provided for the study. The primary objective is to evaluate the impact of smoked cannabis on PTSD symptoms, while also gathering safety data related to its use in this population. Participants will be trained to inhale cannabis under observation initially and then supplied with cannabis or placebos for outpatient use.
Allison Coker, director of cannabis research at MAPS, emphasized the importance of this research, stating, "This breakthrough decision opens the door to future cannabis research, mirroring real-world consumption and generating safety data to guide medical professionals." Coker also clarified that the study is not a therapy study, and participants will not receive psychotherapy as part of the trial.
Context and Rationale
PTSD is a debilitating mental health condition characterized by anxiety, anger, flashbacks, nightmares, depression, and negative thoughts, often stemming from terrifying experiences. Many individuals with PTSD turn to marijuana to manage their symptoms, but there is a lack of robust scientific evidence on its safety and effectiveness that reflects real-world consumption patterns.
"Patients with PTSD commonly use marijuana to manage their symptoms, but there is a lack of scientific evidence on its safety and effectiveness that reflect real-world consumption patterns," Coker said.
The FDA has acknowledged the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and believes that the drug approval process is the best way to ensure safe and effective new medicines are available to patients. The study is funded by the Michigan Veteran Marijuana Research Grant Program, with MAPS serving as the trial sponsor. Sites in Michigan, Arizona, and Florida, including VA facilities, are being considered for the trials.
