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In 2021, federal health officials declined to sign off on a clinical trial to assess the safety and efficacy of using marijuana to treat military veterans with post-traumatic stress disorder.
Allowing patients to smoke high-potency marijuana posed an unjustifiable risk to their health, the Food and Drug Administration said in a written response to the trial proposal. The agency also objected to the suggestion that patients would be allowed to consume as much cannabis as they deemed useful to ease their symptoms, up to a daily limit.
This month, though, the F.D.A. surprised the researchers behind the proposed study and other experts in the field by authorizing the trial to proceed, according to an F.D.A. letter obtained by The New York Times.
The decision was a rare instance in which the F.D.A. has permitted smoking marijuana for a study looking at the therapeutic benefits of the plant, rather than its harms.
A spokeswoman for the F.D.A. said she could not provide details about what led to the approval, but that the agency “recognizes that there is great need for additional treatment options for mental health conditions such as PTSD.” Drug policy experts said it was the latest sign that federal health officials see value in more research on a plant millions of Americans use therapeutically and recreationally.
The federal government has historically prioritized research on the harms of marijuana, but legalization — and the tax revenue that followed — has left states with funds to expand studies into marijuana’s efficacy for therapeutic uses.
