After three years of negotiations, the federal Food and Drug Administration has approved a clinical trial to involve 320 veterans, including Michiganders, who have PTSD and past experience smoking marijuana.
After initially denying inhaled marijuana smoke as a method for using the drug during the study, later FDA documents stated smoking wasn’t safe, but also wasn’t an “unreasonable” risk for people with a “serious condition” like PTSD, who “already engage in this behavior”.
The Multidisciplinary Association for Psychedelic Studies (MAPS) is conducting the phase II clinical trial. The state of Michigan is helping fund it via a $12.9 million grant to MAPS. Michigan has designated a portion of state marijuana tax revenue to contribute to mental health research for veterans. Some number of the study participants will be Michigan residents.
MAPS conducted one similar, smaller study before. Results were unremarkable. Betty Aldworth, director of communication at MAPS, said this study has a larger sample size and will involve participants smoking marijuana with higher concentrations of THC, the psychoactive compound in marijuana that makes users feel high.
(Aldworth talked with Michigan Public’s Tyler Scott about the potential benefits of marijuana for PTSD symptoms, and some potential risks. You can listen to the full audio above.)
Aldworth said inhaling marijuana smoke is one of the fastest ways to experience the drug's effects. Studying marijuana inhalation she said, will provide more scientific data about a behavior that people seem to already be doing.
“What we know anecdotally is that when people are attempting to treat the symptoms of their PTSD, they are more likely to seek faster relief,” Aldworth said. "This also tends to be true for people experiencing chronic pain. So the route of administration they’ll turn to is most likely going to be inhalation: smoking or vaping.”
Aldworth said there’s a dearth of clinical trial data on the potential benefits of smoking marijuana to treat PTSD symptoms. A summary of such research in an article by the National Center for PTSD cites one other previous randomized controlled trial.
However, parts of the federal government are acknowledging growing interest in marijuana research, for PTSD and other conditions. In a New York Times report of FDA approval for this MAPS study, the Times reports an FDA official said the agency “recognizes that there is great need for additional treatment options for mental health conditions such as PTSD."
Three years ago, the U.S. Drug Enforcement Administration expanded the number of companies licensed to produce marijuana for medical and scientific purposes. Previously, there was one licensed facility. Rick Doblin, the executive director of MAPS, called that decision “momentous” for the future of marijuana research.
And in a 2023 paper titled as an agency "perspective” on cannabis research, two FDA officials said the agency had approved roughly 800 studies involving cannabis or cannabis-derived products since 1970, but roughly 400 of those studies had received approval within the past 10 years. The authors predicted increases in the number of proposed marijuana studies applying for FDA approval, and in the number the agency approves.
