Health

The First Study on Marijuana for Vets With PTSD Is in Danger of Being Shut Down

The researchers haven’t been able to recruit enough subjects.

by Ed Cara
Sep 1 2017, 9:37pm

Leander Nardin/Stocksy; Christof Stache/AFP/Getty Images

The federal government's longstanding animosity toward marijuana research is no secret, but in recent years, it appeared to be cooling down.

Two years ago, the Food and Drug Administration (FDA) approved a clinical trial that would test whether cannabis could help treat post-traumatic stress disorder (PTSD) among veterans. Tonic reported in April that the study's researchers finally began recruiting volunteers earlier this year—marking the culmination of a seven-year-long effort headed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a research and educational nonprofit. But despite their initial optimism, the researchers are now worried their study may never get off the ground. And they're blaming the federal government for doing little to help.

The Arizona-based research team has run into a simple but serious problem: They can't find enough volunteers who fit their strict eligibility criteria, Military Times reports. To be considered, vets need to have service-related chronic PTSD and be available for 14 weeks of initial monitoring and 6 months of follow-up. Researchers at Johns Hopkins University in Maryland withdrew as collaborators in April leaving just one research site.

Despite soliciting the help of every veterans' organizations within the state and screening more than 4,000 vets, the team has found only 22 of the 76 volunteers needed to fill out their trial, according to principal study investigator Sue Sisley. "We've depleted that source. And it's still not enough," she told the Military Times.

There is, however, one major wellspring of potential volunteers the team could recruit from: The patients who rely on publicly funded healthcare at the Phoenix Veterans Affairs (VA) Medical Center and other VA facilities. But Sisley said local and federal officials have either not answered or flat-out denied her team's multiple requests to talk to doctors at the center about her research over the last two years. "It's so frustrating," Sisley said. "They say they want more data on ways to help veterans. If they want more data, this is it."

In response to Sisley's comments, VA Press Secretary Curt Cashour told the Military Times (and reiterated in an email to Tonic) that, "Federal law restricts VA's ability to conduct research involving medical marijuana, or to refer Veterans to such research projects."

Cashour also cited a press briefing given by Secretary of Veterans Affairs David Shulkin in May, where he similarly stated the VA could not prescribe medical marijuana for any conditions at its centers because of federal law. "If the researcher is truly interested in finding veterans for her study, she should spend more time recruiting candidates and less time writing letters to the media," he added.

But at that same briefing, Shulkin said "federal law does not prevent us at VA to look at [marijuana] as an option for veterans. I believe that everything that could help veterans should be debated by Congress and by medical experts," adding, "so if there is compelling evidence that this is helpful, I hope that people take a look at that and come up with the right decision, and then we will implement that." Sisley said she's trying to provide that very evidence, but the VA isn't interested in helping.

Sisley has also countered that the VA isn't barred from merely telling patients about the study if it really wanted to, citing a memo released by the Veterans Health Administration in 2012 which states that VA clinicians can discuss and refer patients to non-VA studies where appropriate. Tonic asked Cashour whether Sisley's assertion is accurate, but we haven't heard back yet.

Marijuana is classified alongside heroin as a Schedule I substance by the Drug Enforcement Agency; these drugs are explicitly defined as having "no acceptable medical use." As a result, research into marijuana's health effects, both good and bad, has been slow-moving and underfunded. And veterans in states where medical marijuana is banned also live in fear that their self-medication, if discovered, could cause them to lose their VA benefits.

Meanwhile, earlier this month, the FDA classified another schedule 1 drug, MDMA or ecstasy, as a "breakthrough therapy" for PTSD, a designation that will speed up the review process for its potential full approval.

Sisley told Tonic in April that her work could provide some of the first truly credible proof of pot's benefits in treating PTSD. But if her team is unable to find enough volunteers by October 1, she's worried they'll have to dilute their study by enlisting non-veterans, or shut it down altogether.

"It was a seven-year saga with federal regulations just to get the study to this point," she told the Military Times. "I don't want to see that lost."

If you're interested in signing up for the study, you can visit its Clinicaltrials.gov page.

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