Cannabidiol and Prolonged Exposure
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- PTSD
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants randomly assigned to one of two treatment conditions.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double blind study. Only pharmacist will have access to randomization table.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Prolonged exposure therapy (PE) is among the most efficacious treatments for PTSD and is designated as a VA/DoD frontline treatment. However, PE does not always lead to clinically meaningful symptom reductions in Veterans with PTSD. Successful PE treatment relies on extinction learning, which is oft...
Prolonged exposure therapy (PE) is among the most efficacious treatments for PTSD and is designated as a VA/DoD frontline treatment. However, PE does not always lead to clinically meaningful symptom reductions in Veterans with PTSD. Successful PE treatment relies on extinction learning, which is often impaired in patients with PTSD. Cannabidiol (CBD) is a non-intoxicating phytocannabinoid. Administration of specific phytocannabinoids, like CBD, increase extinction learning in patients with PTSD, and could increase the speed and effectiveness of PE therapy. CBD also modulates 5-HT1A, which may directly improve hyperarousal/insomnia symptoms, and improve engagement and retention in treatment. Given these findings, adjunctive administration of CBD+PE could improve response rates to PE and reduce the number of sessions of PE needed to reach clinically meaningful change. The proposed study is designed to test the efficacy of using CBD in conjunction with PE for the treatment of PTSD in US Military Veterans. A randomized, controlled, double-blind study will compare Veterans who receive PE+CBD to PE+placebo. Participants will include 136 male and female Veterans from all service eras with PTSD. The primary hypothesis is that PE+CBD will reduce PTSD symptoms to a greater degree than PE+placebo.
Tracking Information
- NCT #
- NCT03518801
- Collaborators
- University of California, San Diego
- Investigators
- Principal Investigator: Catherine R Ayers, PhD VA San Diego Healthcare System, San Diego, CA Principal Investigator: Brian Martis, MD VA San Diego Healthcare System, San Diego, CA