Two-Armed Pilot Randomized Controlled Trial of Massed Prolonged Exposure Plus Cannabidiol or Placebo for Posttraumatic Stress Disorder


Examine the safety, feasibility, and symptom reductions associated with cannabidiol (CBD) in military veterans receiving 2 weeks of daily treatment with Prolonged Exposure, a leading therapy for posttraumatic stress disorder (PTSD). Evaluate potential biochemical and physiological changes associated with CBD vs. placebo and the relationship of those changes with the physiological stress response and PTSD symptom reduction.

Up to 20 percent of U.S. military service members who have deployed since Sept. 11, 2001, suffer from posttraumatic stress disorder (PTSD). While evidence-based treatments for PTSD are available, combat-related PTSD is more difficult to treat than cases found in the civilian population. Because of the great need to heal the psychological traumatic injuries incurred by our war fighters, researchers are engaged in ongoing efforts to improve treatments.

Recent research suggests that cannabidiol (CBD), a substance derived from the cannabis plant, may help to regulate brain functions that have become dysregulated due to trauma exposure. CBD interacts with a brain component known as the endocannabinoid system and already is approved by the U.S. Food and Drug Administration (FDA) for treating seizure disorders.

Early evidence also suggests that CBD can help to relieve pain, reduce anxiety and depression, and enhance learning. CBD may also help individuals recover from traumatic events by reducing anxiety and increasing their ability to talk about and make sense of painful memories, two key components of Prolonged Exposure (PE), a leading therapy for PTSD.

Pilot study evaluates combined impact of CBD and behavior therapy

This STRONG STAR-affiliated pilot study led by principal investigator Casey Straud, PsyD, of The University of Texas Health Science Center at San Antonio, will evaluate the potential benefits of administering either CBD or a placebo to a group of 24 patients receiving PE. Their therapy will be in the form of Massed PE, which involves patients receiving daily therapy sessions for 10 days, rather than the standard PE, in which patients receive weekly sessions over the course of a few months.

Twelve of the patients will receive Epidiolex, an FDA-approved, pharmaceutical-grade medication with CBD as its only active component. The other 12 will receive a placebo.

Expected impact

The investigators hypothesize that those receiving CBD will have greater symptom reductions than those in the placebo condition. In addition, they expect that the patients taking CBD will have lower average heart rates during therapy sessions, higher levels of critical biomarkers associated with stress reduction and lower levels of cortisol, a hormone that increases in response to stress. They predict that those measurable physical differences will be associated with improved PTSD symptom reductions.

Any positive findings have the potential to improve PTSD outcomes for service members and veterans and expand understanding of the relationship between PTSD, CBD, and the endocannabinoid system.

Secured By miniOrange