Cannabidiol and Prolonged Exposure

NCT03518801 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MHBB-001-17F
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Keywords

cannabidiol; CBD; PTSD; Veterans

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale DSM 5 (CAPS-5)

  Change in PTSD Symptoms will be assessed by change in Total Severity Score (summed severity ratings on items 1-20) on the Clinician-Administered PTSD Scale DSM 5 (CAPS-5); CAPS-5 Total Severity scores range from 0 to 80; Higher scores indicate higher severity.

  Baseline, Post Treatment (16-weeks), 1-Month Follow-up (20-weeks), 3-Month Follow-up (28-weeks)

Secondary Outcomes (1)

• PTSD Checklist (PCL-5)

  Baseline, Weekly (up to 16-weeks)

Study Arms (2)

Prolonged Exposure + Cannabidiol

EXPERIMENTAL

Psychotherapy plus active medication

Behavioral: Prolonged Exposure; Drug: Cannabidiol

Prolonged Exposure + Placebo

ACTIVE COMPARATOR

Psychotherapy plus placebo medication

Behavioral: Prolonged Exposure; Drug: placebo

Interventions

Prolonged Exposure BEHAVIORAL

psychotherapy

Also known as: PE

Prolonged Exposure + Cannabidiol; Prolonged Exposure + Placebo

Cannabidiol DRUG

active medication

Also known as: CBD

Prolonged Exposure + Cannabidiol

placebo DRUG

non-active medication

Prolonged Exposure + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Diego: collaborator

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind study. Only pharmacist will have access to randomization table.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants randomly assigned to one of two treatment conditions.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 8, 2018
• Study Start: October 1, 2019
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)