'FDA approves study of cannabis to treat PTSD'

 Study is cleared to study 320 veterans with post-traumatic stress disorder

The Multidisciplinary Association for Psychedelic Studies (MAPS) said this week the U.S. Food and Drug Administration approved a study of the therapeutic value of cannabis on 320 veterans with moderate to severe post-traumatic stress disorder (PTSD) after a three-year effort.

The move marks a rare action by the FDA to sanction a study on cannabis despite the plant's current Schedule I classification under federal law as a drug with no therapeutic use, in the same bucket 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 is the sponsor of the effort.

MAPS, a nonprofit research group based in San Jose, Calif., known for its work to legalize MDMA or "Molly" for therapeutic use, said the FDA's Division of Psychiatry Products is allowing a Phase 2 study of smoked cannabis in veterans.

"Removing barriers to research is a key part of MAPS' 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.

The FDA initially placed the study on a partial clinical hold in 2021.

Researchers proposed documenting the experience of 320 veterans who suffer from moderate to severe PTSD who have previously used 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.

All told, the FDA issued five partial clinical hold letters which halted the study. In 2023, MAPS submitted a formal dispute resolution request in an effort to settle the FDA's objections around 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, rather than including people who were naïve about cannabis.

"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, principal investigator for the study, said, "Our veterans are in dire need of treatments that can ease their challenging symptoms of PTSD," according to 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 psychiatric professor at Duke University who works with veterans, told The New York Times he doubts whether cannabis will be effective, based on other 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.

Roughly seven out of every 100 veterans suffer from PTSD, according to the U.S. Department of Veterans Affairs. Based on that estimate, about 1.1 million of the U.S.'s 15.8 military veterans suffer from some form of PTSD.

There are signs now 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 for the Department of Health and Human Services, has supported federal legalization of cannabis.

Signs of a thaw towards cannabis on the federal level came under the Biden administration's move last year to propose a reclassification of cannabis to Schedule III, a less dangerous level but still a controlled substance. That process now rests with the Drug Enforcement Administration, which is planning to hold a hearing on the proposal next year.

Cannabis has been legalized in 25 states for recreational use, while 38 states have medical-use programs. In November, voters in Florida rejected allowing for the recreational use of cannabis, despite an endorsement from Donald Trump. But Nebraska voters OK'd a measure for the state to launch a medical program.

https://www.morningstar.com/news/marketwatch/20241122243/fda-approves-study-of-cannabis-to-treat-ptsd