FDA Greenlights Clinical Trial on Marijuana Use for PTSD in Veterans
In a landmark decision, the Food and Drug Administration (FDA) has approved a clinical trial focusing on the potential benefits of marijuana for veterans suffering from PTSD. This trial, which has been three years in the making, will involve 320 veterans, including participants from Michigan, who have previously used marijuana.
Initially, the FDA had reservations about inhaled marijuana smoke as a method during the study. However, subsequent FDA documents indicated that while smoking isn’t entirely safe, it is not considered an “unreasonable” risk for individuals with severe conditions like PTSD, who already engage in smoking marijuana.
The Multidisciplinary Association for Psychedelic Studies (MAPS) is spearheading this phase II clinical trial, with financial support from the state of Michigan. The state is contributing through a $12.9 million grant, sourced from marijuana tax revenue allocated for veterans’ mental health research. Michigan residents are expected to be among the study’s participants.
MAPS had previously conducted a smaller-scale study with limited results. Betty Aldworth, MAPS’ director of communication, noted that the current study boasts a larger sample size and will examine the effects of marijuana with higher THC concentrations, the psychoactive component responsible for the drug’s high. Aldworth has discussed the potential benefits and risks of marijuana for PTSD symptoms in a conversation with Michigan Public’s Tyler Scott.
According to Aldworth, smoking marijuana is a rapid method for experiencing the drug’s effects. She emphasized that researching marijuana inhalation could yield valuable scientific data about a behavior many already practice. “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 explained. “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.”
Currently, there is a lack of clinical data on the potential benefits of smoking marijuana for PTSD, with the National Center for PTSD highlighting one other randomized controlled trial in this area. However, interest in marijuana research is growing within parts of the federal government. According to a New York Times report, an FDA official acknowledged the pressing need for more treatment options for mental health conditions like PTSD.
In a move that could bolster future marijuana research, the U.S. Drug Enforcement Administration expanded the number of companies authorized to cultivate marijuana for medical and scientific purposes three years ago. Previously, only one facility held a license. Rick Doblin, MAPS’ executive director, hailed this development as “momentous” for marijuana research.
Furthermore, a 2023 paper by FDA officials highlighted that the agency has approved approximately 800 studies involving cannabis or its derivatives since 1970, with about 400 of those approvals occurring within the last decade. The authors anticipate a rise in the number of proposed and approved marijuana studies by the FDA.
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