CompletedPhase 2

Cannabidiol and Prolonged Exposure

United States136 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT03518801

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More PTSD trials