COMPLETED

Cannabidiol and Prolonged Exposure

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD

Quick Facts

Study Start:2019-10-01

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03518801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Catherine R Ayers, PhD

PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Brian Martis, MD

PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Catherine R Ayers, PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA
Brian Martis, MD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-01

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2019-10-01

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

cannabidiol
CBD
PTSD
Veterans

Additional Relevant MeSH Terms

PTSD