Using CBD to enhance PTSD treatment for Veterans
Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD
This study is testing if adding CBD to a therapy for PTSD can help military Veterans feel better compared to just the therapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT03518801 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of Cannabidiol (CBD) as an adjunct to Prolonged Exposure therapy (PE) for military Veterans suffering from PTSD. It involves a randomized controlled design comparing the outcomes of Veterans receiving PE combined with CBD versus those receiving PE with a placebo. The study aims to determine if CBD can improve treatment outcomes by enhancing extinction learning and reducing PTSD symptoms more effectively than placebo. Conducted at the VA San Diego Medical Center, it includes 136 participants from various service eras.
Who should consider this trial
Good fit: Ideal candidates are military Veterans over 18 years old who meet the clinical criteria for PTSD.
Not a fit: Patients with significant allergic reactions to cannabinoids or those currently engaged in trauma-related psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve PTSD treatment outcomes for Veterans, potentially reducing the number of therapy sessions needed.
How similar studies have performed: Other studies have shown promise in using cannabinoids for PTSD treatment, but this specific combination with PE is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over the age of 18 at the time of screening. * Judged by the study physician to be in generally good health. * Meet clinical criteria for Posttraumatic Stress Disorder (PTSD) on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). * Negative urine pregnancy test. Exclusion Criteria: * History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to cannabinoids. * Used cannabis, synthetic cannabinoid, cannabinoid analogue, or any CBD or THC-containing product within 30 days of eligibility screening. * Patient has had a change in psychopharmacotherapy regimen in the last 4 weeks, or has any plans to change regimen over the course of the study. * Patient is engaged in trauma-related psychotherapy for PTSD. * Current or past DSM-5 diagnosis of dissociative identity disorder, eating disorder with active purging, personality disorders, primary psychotic disorder, or bipolar affective disorder type 1. * Patient is currently prescribed medications with possible CBD-drug interactions. * History of actual suicide attempt in the last 5 years. * Unmanaged obstructive sleep apnea. * Positive drug screen for THC, barbiturates, amphetamines (if not prescribed), benzodiazepines, and/or opiates. * History of treatment for, or evidence of, moderate to severe alcohol or drug abuse within the past year or regular alcohol consumption exceeding recommended limits. * Lifetime history of Cannabis Use Disorder. * Pregnant or breastfeeding.
Where this trial is running
San Diego, California
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Catherine R Ayers, PhD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Julie M Holcomb, MS BS
- Email: julie.holcomb@va.gov
- Phone: (858) 552-8585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.