Study to involve 320 veterans with post-traumatic stress disorder
A rare approval from the U.S. Food and Drug Administration of a study of cannabis, which will focus on veterans with post-traumatic stress disorder, could one day provide a boost to the cannabis sector, given the number of people facing the issue.
Roughly seven out of every 100 veterans have PTSD, according to the U.S. Department of Veterans Affairs. Based on that estimate, about 1.1 million of the 15.8 million military veterans in the U.S. suffer from some form of PTSD.
Given the large number of veterans who could use a new treatment for PTSD, a favorable study on cannabis could pave the way for more widespread use of the plant.
That in turn could boost components of the AdvisorShares Pure U.S. Cannabis ETF MSOS. The exchange-traded fund of U.S. cannabis stocks is down 34.8% so far in 2024, as an effort to reschedule cannabis to a less restrictive category of drugs on the federal level remains in limbo and as Congress has yet to approve pro-cannabis legislation such as the SAFER Banking bill.
A result of the PTSD study showing no benefit, meanwhile, could hamper the sector.
But any positive or negative impact on the cannabis sector resulting from the PTSD study would likely be years away, given the lengthy process for commercialization of drug treatments.
The Multidisciplinary Association for Psychedelic Studies said this week that the FDA has approved the study, which will look at the therapeutic value of cannabis in 320 veterans with moderate to severe PTSD.
Sanctioning a study on cannabis amounts to a rare action by the FDA. Cannabis is currently classified under federal law as a Schedule I drug with no therapeutic use, in the same category as heroin and LSD.
An FDA spokesperson told the New York Times that the agency "recognizes that there is a great need for additional treatment options" for PTSD.
The roughly $13 million trial is being funded by the Michigan Veteran Marijuana Research Grant Program. MAPS, a nonprofit research group based in San Jose, Calif., that is known for its work to legalize MDMA, or "molly," for therapeutic use, is the sponsor of the effort.
"Removing barriers to research is a key part of MAPS's mission, and we are glad to have negotiated a resolution to these long-standing obstacles in cannabis research to support all future cannabis researchers," Allison Coker, director of cannabis research at MAPS, said in a prepared statement.
During MAPS's three-year effort to win approval of the study, the FDA issued five partial clinical hold letters. In 2023, MAPS submitted a formal dispute-resolution request in an effort to settle the FDA's objections, which related to the proposed THC dose of the cannabis-flower product, smoking as a delivery method, vaping as a delivery method and the enrollment of participants who lacked knowledge of cannabis.
MAPS agreed to study only veterans who had prior experience with cannabis.
"The study is designed to investigate the inhalation of high-THC dried cannabis flower, versus placebo cannabis, with the daily dose being self-titrated by participants," MAPS said.
"Despite the increasingly widespread use and acceptance of cannabis in patients with PTSD, labeled as 'medical use' in many states, there is still a lack of high-quality, controlled data on the safety and effectiveness of cannabis use that reflects real-world consumption patterns," Coker said.
Sue Sisley is an Arizona-based physician and the principal investigator for the study. "Our veterans are in dire need of treatments that can ease their challenging symptoms of PTSD," Sisley said in a prepared statement. "In my own practice, veteran patients have shared how smoking cannabis helped them manage their PTSD symptoms more than traditional pharmaceuticals."
However, other medical professionals said questions remain about the effectiveness of cannabis.
Harold Kudler, an associate professor pf psychiatry at Duke University who works with veterans, told the New York Times he doubts whether cannabis will be effective, based on studies done in the past.
"I couldn't in good conscience recommend it to anybody because I'd feel I was doing more harm than good," he said.
However, he said he supports the FDA's decision to allow more research.
There are signs that the incoming Trump administration may take a favorable stand toward cannabis.
Robert F. Kennedy Jr., who President-elect Donald Trump has picked to be his nominee to head the Department of Health and Human Services, has supported federal legalization of cannabis.
Signs of a thaw toward cannabis on the federal level came last year as the Biden administration proposed moving cannabis to Schedule III, a less restrictive classification level for controlled substances. That process now rests with the Drug Enforcement Administration, which is planning to hold a hearing on the proposal next year.
Also read: Cannabis stocks drop sharply as DEA sets drug-rescheduling hearing after November election
Cannabis has been legalized in 25 states for recreational use, while 38 states have medical-use programs. In November, voters in Florida rejected allowing the recreational use of cannabis, despite an endorsement from Donald Trump, while Nebraska voters approved a measure for the state to launch a medical program.
-Steve Gelsi
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