CBD-PENCT03518801

Cannabidiol and Prolonged Exposure

StatusCompleted

PhasePhase 2

SponsorVA Office of Research and Development

Primary completionSep 30, 2025

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Record History

All 18 versions: 15 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Oct 5, 2026 Results posted: Oct 28, 2026
- Eligibility criteria expanded, about 16 words
- Secondary endpoints: details revised at 1 of 1 entry
Minor Oct 15, 2025 Trial status: Recruiting to Completed
- Site details revised
v16
Notable Oct 3, 2024 Primary and study completion dates: Sep 30, 2024 to Sep 30, 2025
- Start date: Mar 1, 2019 to Oct 1, 2019
- Site contact updated
v15
Minor Sep 12, 2023 Site details revisedv13
Notable Sep 30, 2021 Primary and study completion dates: Sep 30, 2023 to Sep 30, 2024v11

Show 9 earlier versionsHide 9 earlier versions

Minor Dec 23, 2020 Site contact updatedv10
Minor Jul 14, 2020 Eligibility criteria expanded, about 3 wordsv9
Minor Feb 3, 2020 Eligibility criteria shortened, about 6 wordsv8
Minor Aug 6, 2019 Site contact updated
- Eligibility criteria expanded, about 4 words
v7
Notable Mar 5, 2019 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Feb 11, 2019 to Mar 1, 2019
- Site details revised
v6
Minor Feb 5, 2019 Start date: Feb 1, 2019 to Feb 11, 2019v5
Notable Jan 9, 2019 Start date: Dec 31, 2018 to Feb 1, 2019v4
Notable Nov 8, 2018 Start date: Nov 1, 2018 to Dec 31, 2018v3
Notable Sep 26, 2018 Start date: Oct 1, 2018 to Nov 1, 2018
- Eligibility criteria expanded, about 3 words
v2

Apr 25, 2018 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

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)

Secondary (1)

PTSD Checklist (PCL-5)

Arms and interventions

Prolonged Exposure + CannabidiolExperimental

Psychotherapy plus active medication

Prolonged Exposure + PlaceboActive comparator

Psychotherapy plus placebo medication

Behavioral: Prolonged Exposure

Drugs: Cannabidiol, placebo

Sites

1 site in 1 country

VA San Diego Healthcare System, San Diego, CASan Diego, California, United States

About this trial

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.

Trial details

Enrollment: 136 participants (actual)
Started: Oct 1, 2019
Study completion: Sep 30, 2025
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Stress Disorders, Post-Traumatic, PTSD
Collaborators: University of California, San Diego
Official title: Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD
First posted: May 8, 2018
Registry updated: Oct 28, 2026
Last verified: Oct 2026

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