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CBD + Prolonged Exposure for PTSD (CBD-PE Trial)

Phase 2
Recruiting
Led By Catherine R Ayers, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet clinical criteria for Posttraumatic Stress Disorder (PTSD) on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Over the age of 18 at the time of screening
Must not have
Unmanaged obstructive sleep apnea
Positive drug screen for THC, barbiturates, amphetamines (if not prescribed), benzodiazepines, and/or opiates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post treatment (16-weeks), 1-month follow-up (20-weeks), 3-month follow-up (28-weeks)
Awards & highlights

Summary

This trial will compare the effectiveness of using CBD alongside exposure therapy to just exposure therapy in treating PTSD in military veterans.

Who is the study for?
This trial is for military Veterans over 18 with PTSD, as confirmed by a specific clinical scale. They must be in good health and not pregnant. Participants cannot have used cannabis products recently, be on certain medications, or be undergoing other trauma-related psychotherapy.Check my eligibility
What is being tested?
The study tests if Cannabidiol (CBD) can improve the effectiveness of Prolonged Exposure therapy for PTSD when compared to a placebo. It's conducted at the VA San Diego Medical Center with 136 participants who are randomly assigned to either the CBD group or placebo group.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. Since it's being tested alongside therapy rather than more potent drugs, severe side effects are less likely but will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PTSD by a professional.
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have sleep apnea that is not currently being treated.
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I have not tested positive for THC, barbiturates, amphetamines (unless prescribed), benzodiazepines, or opiates.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post treatment (16-weeks), 1-month follow-up (20-weeks), 3-month follow-up (28-weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post treatment (16-weeks), 1-month follow-up (20-weeks), 3-month follow-up (28-weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Administered PTSD Scale DSM 5 (CAPS-5)
Secondary outcome measures
PTSD Checklist (PCL-5)
Other outcome measures
UKU Side Effects Rating Scale, Patient Version (UKU-SERS-Pat)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged Exposure + CannabidiolExperimental Treatment2 Interventions
Psychotherapy plus active medication
Group II: Prolonged Exposure + PlaceboActive Control2 Interventions
Psychotherapy plus placebo medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure
2010
Completed Phase 3
~1440
Cannabidiol
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER
1,135 Previous Clinical Trials
1,551,108 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,843 Total Patients Enrolled
Catherine R Ayers, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
3 Previous Clinical Trials
303 Total Patients Enrolled

Media Library

Prolonged Exposure Clinical Trial Eligibility Overview. Trial Name: NCT03518801 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Prolonged Exposure + Placebo, Prolonged Exposure + Cannabidiol
Post-Traumatic Stress Disorder Clinical Trial 2023: Prolonged Exposure Highlights & Side Effects. Trial Name: NCT03518801 — Phase 2
Prolonged Exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT03518801 — Phase 2
~4 spots leftby Sep 2024