A first-of-its-kind clinical trial will look at the effectiveness of medical marijuana in treating post traumatic stress disorder among veterans.
The Drug Enforcement Agency’s approval this week marks the first time a U.S regulatory agency has signed off on a study aimed at developing smoked whole-plant marijuana into a legal prescription drug, according to the Multidisciplinary Association for Psychedelic Studies, the nonprofit group sponsoring the research.
Dr. Suzanne Sisley, who will run half of the trials from Arizona, told The Huffington Post the go-ahead comes more than six years after the study design was submitted to the Food and Drug Administration.
Sisley said that she feels indebted to the many military veterans who have stuck through the long, frustrating process and encouraged her and others not to give up.
“It feels like a real triumph,” she added. “It’s a chance for science to overcome politics.”
The California-based MAPS said the Colorado Department of Health and Environment funded a $2.2 million grant for the triple-blind, placebo-controlled study. Seventy-six U.S. military veterans with treatment-resistant PTSD will participate. Sisley will treat half of the patients in Phoenix and Johns Hopkins University in Baltimore, Maryland, will oversee the others.
Sisley told HuffPost that while observational studies of marijuana’s effect on those with PTSD have been conducted, randomized control trials are the “gold standard” when it comes to persuading the medical community. Sisley does not have preconceived notions about the study outcome, but she said she can’t ignore the anecdotal information she’s heard from veterans across the country, many of whom tell her that cannabis saved their lives.
“We’re hoping and praying that this plant proves to be helpful in reducing the severity of PTSD,” Sisley said.
The DEA approval allows the research team to buy marijuana from the National Institute of Drug Abuse, the Military Times reports.
“The contract with the state of Colorado was signed on April 20 — an unofficial national holiday in some circles — meaning the funds are en route to MAPS,” a MAPS spokesman told the publication. “We are now preparing to place the order for the marijuana for the study.”
MAPS notes in its announcement that the trial study will use four different marijuana strains and potencies, and “provide vital information on marijuana dosing, composition, side effects, and areas of benefit to clinicians and legislators” considering pot as a treatment. It could begin as early as June.
The U.S. Department of Veterans Affairs says that while veterans are using marijuana to relieve post traumatic stress disorder symptoms, “controlled studies have not been conducted to evaluate the safety or effectiveness of medical marijuana for PTSD.”
The VA estimates PTSD afflicts almost 31 percent of Vietnam veterans, 20 percent of Iraq war vets and 11 percent of those who fought in Afghanistan. Each day, 22 veterans commit suicide, a 2012 study found.
Sisley told HuffPost the goal of the study is simple: Find out if cannabis is beneficial and, if so, which strains — if any — work better than others.
“I’m not pro-marijuana,” Sisley said. “I’m pro-science.”