The U.S. Food and Drug Administration last week approved a California nonprofit research organization’s proposal to conduct a clinical trial to study the effectiveness of cannabis as a treatment for post-traumatic stress disorder in veterans. In the study, the Multidisciplinary Association for Psychedelic Studies will investigate the use of smoked and vaped cannabis by more than 300 veterans diagnosed with moderate or severe PTSD.
“After 3 years of negotiations with the FDA, this decision opens the door to future research into cannabis as a medical treatment, offering hope to millions,” MAPS wrote in a statement about the FDA’s approval of the study.
PTSD is a mental health condition that causes anger, flashbacks, emotional distress, and other symptoms among individuals who have experienced or witnessed a horrific, terrifying, or life-threatening event. The U.S. Department of Veterans Affairs reports that nearly 16% of veterans who deployed to the wars in Iraq and Afghanistan screened positive for PTSD in a recent study. The condition is often treated with psychotherapy, cognitive behavior therapy, medications such as antidepressants, and other therapies with varying degrees of success.
With the FDA’s approval, MAPS will conduct a randomized, placebo-controlled Phase 2 clinical study of 320 veterans diagnosed with moderate or severe PTSD who have previously used cannabis. The group said 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.” The research is designed to reflect existing cannabis consumption patterns among veterans and investigate “the ‘real-world’ use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.”
Study Investigates Real-World Cannabis Use
During the five-week study, participants will smoke or vape cannabis or a cannabis placebo and then rate their symptoms of PTSD using an app on a smartphone or other mobile device. Participants will self-regulate their dose and frequency of cannabis use but must agree to limit their cannabis consumption to the amount provided for the study. Researchers will then analyze the results to develop data on the safe use of cannabis that will be used to guide future studies.
“These data are critical to inform patients, medical providers, and adult-use consumers when considering cannabis in treatment plans for the management of PTSD, pain, and other serious health conditions, yet regulatory obstacles have historically made it difficult or impossible to conduct meaningful research on the safety and effectiveness of cannabis products typically consumed in regulated markets,” the organization noted.
Sue Sisley, a psychiatrist and the lead researcher for the study, said in a statement that the clinical trial will help provide information on the efficacy of using smoked cannabis to treat PTSD. She noted that while PTSD is included as a qualifying condition for the medical cannabis programs in many states, there is little data on its efficacy as a treatment for the condition.
“Within the United States, millions of Americans are smoking or vaporizing cannabis to manage or treat their symptoms,” Sisley said. “In the absence of high-quality data related to cannabis, much of the information available to patients and regulators is rooted in prohibition and focused only on potential risks, without consideration of potential benefits.”
“In my own practice, Veteran patients have shared how smoking cannabis helped them manage their PTSD symptoms more than traditional pharmaceuticals,” she continued. “Suicide among Veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments for life-threatening health conditions like PTSD.”
The study is being funded by Michigan’s Veteran Marijuana Research Grant Program, which uses state cannabis tax revenue to support FDA-approved, nonprofit-sponsored clinical trials “researching the efficacy of marijuana in treating the medical conditions of United States armed services veterans and preventing veteran suicide,” according to a report from online cannabis news source Marijuana Moment. State officials announced in 2021 that $13 million of a $20 million funding round would be used to support the PTSD study.
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