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Cannabidiol and Prolonged Exposure (CBD-PE)

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ClinicalTrials.gov Identifier: NCT03518801
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Prolonged Exposure Drug: Cannabidiol Drug: placebo Phase 2

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Official Title: Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Arm Intervention/treatment
Experimental: Prolonged Exposure + Cannabidiol
Psychotherapy plus active medication
Behavioral: Prolonged Exposure
psychotherapy
Other Name: PE

Drug: Cannabidiol
active medication
Other Name: CBD

Active Comparator: Prolonged Exposure + Placebo
Psychotherapy plus placebo medication
Behavioral: Prolonged Exposure
psychotherapy
Other Name: PE

Drug: placebo
non-active medication




Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale DSM 5 (CAPS-5) [ Time Frame: Baseline, Post Treatment (16-weeks), 1-Month Follow-up (20-weeks), 3-Month Follow-up (28-weeks) ]
    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.


Secondary Outcome Measures :
  1. PTSD Checklist (PCL-5) [ Time Frame: Baseline, Weekly (up to 16-weeks) ]
    Rate of PTSD symptom reduction will be assessed by comparing the time-to-event of clinical response to treatment. The time-to-event is defined by number of PE sessions completed before patient achieves a 10-point reduction from baseline in total (summed) PTSD Checklist scores (PCL-5). PCL-5 Total Scores range from 0 to 80; Higher scores indicate worse functioning.


Other Outcome Measures:
  1. UKU Side Effects Rating Scale, Patient Version (UKU-SERS-Pat) [ Time Frame: Weekly (up to 16 weeks) ]
    Total Adverse Events (AEs) will be tallied numerically by condition using the UKU Side Effects Rating Scale, Patient Version (UKU-SERS-Pat)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  • Body mass index between 18-35 kg/m2.
  • 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.
  • Obstructive sleep apnea.
  • Positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates.
  • History of treatment for, or evidence of, alcohol or drug abuse within the past year or regular alcohol consumption exceeding recommended limits.
  • Lifetime history of Cannabis Use Disorder.
  • Pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518801


Contacts
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Contact: Mallory J Loflin, PhD MA BA (858) 552-8585 Mallory.Loflin@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Mallory J Loflin, PhD MA BA    858-552-8585    Mallory.Loflin@va.gov   
Principal Investigator: Mallory J. Loflin, PhD MA BA         
Sponsors and Collaborators
VA Office of Research and Development
University of California, San Diego
Investigators
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Principal Investigator: Mallory J. Loflin, PhD MA BA VA San Diego Healthcare System, San Diego, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03518801     History of Changes
Other Study ID Numbers: MHBB-001-17F
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
cannabidiol
CBD
PTSD
Veterans

Additional relevant MeSH terms:
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Epidiolex
Anticonvulsants