Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD

Who is this study for? Adult veterans with post-traumatic stress disorder
What treatments are being studied? Cannabidiol
Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The trial will include a randomized control trial to evaluate the efficacy of using Cannabidiol (CBD), a non-intoxicating cannabinoid, as an adjunctive to Prolonged Exposure therapy (PE). The trial will compare PE + CBD to PE + placebo in a sample of 136 military Veterans with PTSD at the VA San Diego Medical Center. The study represents the logical and innovative next step for augmenting existing treatments and developing novel pharmacotherapy for PTSD. Findings from the proposed RCT will inform clinical practice and policy by investigating whether administration of CBD in the context of PE therapy will improve treatment outcomes for military Veterans with PTSD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
Contact Information
Primary
Julie M Holcomb, MS BS
julie.holcomb@va.gov
(858) 552-8585
Backup
Catherine R Ayers, PhD
Catherine.Ayers1@va.gov
(858) 642-2976
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 136
Treatments
Experimental: Prolonged Exposure + Cannabidiol
Psychotherapy plus active medication
Active_comparator: Prolonged Exposure + Placebo
Psychotherapy plus placebo medication
Authors
Mallory J. Loflin
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov