FDA Approves Clinical Trial On Cannabis In Veterans With PTSD

After three years of negotiation, the FDA has given MAPS the green light to carry out a Phase 2 randomized, placebo-controlled study in 320 veterans suffering from moderate to severe PTSD.

The trial, which is being funded by the Michigan Veteran Marijuana Research Grant Program, aims to generate safety data about cannabis use that mirrors real-world consumption, developing an evidence base to inform medical professionals.

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.

Initially placed on partial clinical hold by the FDA in 2021, over the last three years, the regulator has issued five partial clinical hold letters which halted the progression of the trial.

MAPS achieved a resolution on key issues when the FDA indicated that they would allow the trial to proceed with self-titration dosing of smoked cannabis with a THC potency that corresponds to what is commercially available in states permitting legal medical and/or adult-use cannabis programs.

The FDA also no longer objects to vaporization as a delivery method. However, the use of any specific vaporization device requires additional information on its mechanics to assess its safety for use with patients. Therefore, the FDA cleared the study to proceed with smoking administration but retained the partial clinical hold on the vaping device until the requested information is provided.

Allison Coker, PhD, Director of Cannabis Research, MAPS, said: “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. MAPS designed MJP2 to bridge this evidence gap by studying the ‘real-world’ use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.

“These data are critical to inform patients, medical providers, and adult-use consumers when considering cannabis in treatment plans for the management of PTSD, pain, and other serious health conditions, yet regulatory obstacles have historically made it difficult or impossible to conduct meaningful research on the safety and effectiveness of cannabis products typically consumed in regulated markets.”

“The updated opinions expressed by the FDA in response to the FDRR demonstrate a willingness to recognize the value of high-quality data on the risks and potential benefits of the already-occurring widespread use of cannabis for managing PTSD. Removing barriers to research is a key part of MAPS’ mission, and we are glad to have negotiated a resolution to these long-standing obstacles in cannabis research to support all future cannabis researchers.”

The FDA maintains that cannabis naïve participants would be subject to unreasonable risk in the study. While MAPS disagrees that cannabis naïve participants smoking or vaporizing cannabis (in an amount of their choosing) for a 5-week period would expose them to “unreasonable and significant risk,” MAPS updated the protocol to require that all participants must have “prior experience inhaling (smoking or vaporizing) cannabis.”

Rick Doblin, PhD, Founder and President, MAPS, added: “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.”