FDA’s initial reluctance, the study is finally moving forward.
Landmark Clinical Trial for Medical Marijuana and PTSD Gets Green Light from FDA
After years of delays, researchers are finally making progress on a groundbreaking clinical trial to evaluate the effectiveness of smoked medical marijuana in treating post-traumatic stress disorder (PTSD) in military veterans. And the best part? It’s being funded by tax revenue from legal cannabis sales in Michigan.
MAPS Announces FDA Approval for Phase 2 of Study on Cannabis and PTSD
The Multidisciplinary Association for Psychedelic Studies (MAPS) has announced that the U.S. Food and Drug Administration (FDA) has given the green light for Phase 2 of their research on the use of smoked medical marijuana to treat PTSD in veterans. This randomized, placebo-controlled study will involve 320 veterans who have previously used cannabis and suffer from moderate to severe PTSD.
Real-World Use of High THC Cannabis to Be Studied in Landmark Trial
The study, which will be self-titrated by participants, aims to reflect the consumption patterns already seen across the country. By studying the “real-world” use of inhaled cannabis, researchers hope to gain a better understanding of its potential benefits and risks in treating PTSD.
Years of Negotiations and Obstacles Finally Resolved for MAPS
According to MAPS, the project has been years in the making and has faced numerous challenges in gaining FDA approval. After responding to five partial clinical hold letters, the organization submitted a Formal Dispute Resolution Request to resolve disagreements on key issues such as THC dosage, smoking and vaping as delivery methods, and the enrollment of cannabis-naïve participants.
Study Will Provide Critical Data for Patients, Providers, and Consumers
The results of this study will be crucial in informing patients, medical providers, and adult-use consumers about the potential benefits and risks of using cannabis to treat PTSD, pain, and other serious health conditions. Despite initial pushback from the FDA, the study is now moving forward and will help shed more light on the scientific legitimacy of using smoked marijuana for PTSD.
