The Food and Drug Administration (FDA) this week authorized a long-delayed clinical trial to test whether smoking marijuana can be used to treat post-traumatic stress disorder (PTSD) in veterans.
The trial, sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), has been blocked by the FDA since 2021. The agency had raised a variety of objections, including that allowing people to inhale high-potency cannabis was dangerous to their health.
The FDA also objected to the study’s “self-titration” dosing method, which will allow participants to smoke as much cannabis as they feel they need to relieve their symptoms up to a daily limit.
But on Wednesday, MAPS announced that the FDA will allow the trial to proceed. Importantly, they said the FDA no longer objects to either smoking or letting participants choose their preferred amount.
“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,” the organization said in a statement.
FDA also will allow the trial to use a THC potency that matches commercially available cannabis in states permitting legal medical or recreational adult use.
One requirement the agency insisted on was that the study participants must have “prior experience” inhaling cannabis.
Allison Coker, director of cannabis research at MAPS, said they did not want to change the study design to fit how the FDA has historically viewed marijuana research. The trial is meant to mimic how veterans may use cannabis in their daily lives, the way it’s delivered and the amount that’s delivered.
