The FDA has granted clearance for a Phase 2 clinical trial examining the use of smoked cannabis for the treatment of PTSD symptoms among veterans. This decision, secured by the Multidisciplinary Association for Psychedelic Studies (MAPS), follows three years of negotiations and addresses critical issues related to cannabis research. The trial aims to generate safety data reflecting real-world cannabis consumption patterns, providing an evidence base for medical professionals.
Trial Design and Objectives
The randomized, placebo-controlled study will involve 320 veterans suffering from moderate to severe PTSD. Participants will self-titrate their daily dose of high-THC dried cannabis flower versus a placebo. This approach mirrors real-world consumption, allowing researchers to understand the potential benefits and risks of cannabis use in treating PTSD.
The Michigan Veteran Marijuana Research Grant Program is funding the trial. Researchers will investigate the inhalation of high-THC dried cannabis flower, versus placebo with the daily dose being self-titrated by participants who have previously used cannabis.
Overcoming Regulatory Hurdles
Initially placed on partial clinical hold by the FDA in 2021, MAPS has worked to address the regulator's concerns. A key breakthrough was the FDA's agreement to allow self-titration dosing of smoked cannabis with a THC potency corresponding to commercially available products in states with legal cannabis programs.
Allison Coker, PhD, Director of Cannabis Research at MAPS, emphasized the importance of this research: "Despite the increasingly widespread use and acceptance of cannabis in patients with PTSD, labeled as ‘medical use’ in many states, there is still a lack of high-quality, controlled data on the safety and effectiveness of cannabis use that reflects real-world consumption patterns."
Implications for Cannabis Research
The FDA's updated stance reflects a growing recognition of the need for data on the risks and potential benefits of cannabis for managing PTSD. This trial challenges the FDA’s typical approach to scheduled dosing and administration of drugs, ensuring that cannabis research reflects actual cannabis use.
Rick Doblin, PhD, Founder and President of MAPS, stated, "MAPS takes pride in leading the way to open new research pathways by challenging the FDA to think differently... 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."
The Need for Alternative PTSD Treatments
In 2021, about 11 percent of veterans were diagnosed with PTSD. Current treatments do not work for everyone, so this study is important to explore additional treatment options.
Future Directions
This clinical trial represents a significant step forward in cannabis research, potentially paving the way for more veteran-focused studies and informing medical practices related to PTSD treatment.
