FDA Approves Trial Investigating Medical Cannabis as PTSD Treatment for Veterans

The U.S. Food and Drug Administration (FDA) this week approved a clinical trial to investigate whether smoking or vaping medical cannabis products can help to treat post-traumatic stress disorder (PTSD) among veterans, The Hill reports.

Funded by the Michigan Veteran Marijuana Research Grant Program and sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the trial faced delays in 2021 after FDA officials objected to several aspects of the study: that inhaling cannabis smoke might be potentially dangerous for study participants, and that the study would follow a “self-titration” dosing method that would allow participants to use as much medical cannabis as they believe could be of benefit, rather than a prescribed amount. Additionally, the FDA was concerned about letting participants use high-potency products.

However, in a statement released Wednesday, MAPS said that the FDA no longer objected to those aspects of the study.

“After three years of negotiations with the FDA, this decision opens the door to future research into cannabis as a medical treatment, offering hope to millions.” — MAPS statement, via The Hill

MAPS’ director of cannabis research Allison Coker said in the report that the group didn’t want the study to be changed based on the federal agency’s objections because the trial is meant to mimic the actual habits of veterans who are already using medical cannabis.

The trial will be a randomized, placebo-controlled study involving 320 veterans experiencing moderate to severe PTSD. In addition to the placebo products, the trial will utilize high-potency cannabis products sourced from Canada, the report said.