Recruitment

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