The Food and Drug Administration (FDA) has given the green light to the Multidisciplinary Association for Psychedelic Studies (MAPS), a California-based non-profit, to commence clinical trials investigating the use of smoked cannabis for treating post-traumatic stress disorder (PTSD) in veterans.
The study, titled MJP2, is a Phase 2 trial that will involve 320 veterans diagnosed with moderate to severe PTSD. Participants will self-administer cannabis at home over a five-week period and monitor their symptoms using a mobile app. The trial is designed as a double-blind study, meaning neither the participants nor the clinicians will know whether they are receiving active cannabis or a placebo.
Study Design and Objectives
The primary objective of the study is to assess the impact of cannabis on PTSD symptoms. Veterans participating in the trial must have prior experience smoking cannabis and agree to limit their use to the doses provided. Assessments of PTSD symptoms will be conducted at the beginning and end of the treatment period.
Allison Coker, director of cannabis research at MAPS, emphasized the significance of this decision, stating, "This breakthrough decision opens the door to future cannabis research, mirroring real-world consumption and generating safety data to guide medical professionals."
The Need for Cannabis Research in PTSD
PTSD is a debilitating mental health condition characterized by anxiety, anger, flashbacks, nightmares, depression, and negative thoughts following terrifying events. Hether Zeckser, a veteran and advocate for cannabis research, shared her personal experience, noting that cannabis helps alleviate her service-connected PTSD symptoms, unlike the medications prescribed by the Department of Veterans Affairs.
Currently, many patients with PTSD use marijuana to manage their symptoms, but there is a lack of comprehensive scientific evidence regarding its safety and effectiveness. This study aims to address this gap by providing data that reflects real-world consumption patterns.
FDA's Position on Cannabis Research
The FDA acknowledges the potential therapeutic benefits of cannabis and cannabis-derived compounds. The agency believes that the drug approval process is the most effective way to ensure that safe and effective cannabis-based medicines are available to patients in need.
Trial Logistics
Participants will initially undergo training to inhale cannabis under observation. Following this, they will be provided with cannabis or placebos for outpatient use. Potential trial sites include facilities in Michigan, Arizona, and Florida, with the inclusion of VA facilities under consideration. It is important to note that the study will not include mental health counseling.
"This is not a therapy study, and participants will not receive psychotherapy," Coker clarified.
The study is funded by the Michigan Veteran Marijuana Research Grant Program, with MAPS serving as the trial sponsor. While the FDA has cleared the study to proceed, MAPS is still in discussions with the agency regarding the trial's start date.
