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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
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

CBD-PE Trial 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.

CBD-PE Trial Eligibility Criteria

Inclusion Criteria

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

CBD-PE Trial 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)

CBD-PE 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
1,120 Previous Clinical Trials
1,521,271 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,293 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are partaking in this research?

"Affirmative, the information available on clinicaltrials.gov confirms that this study is actively recruiting participants. It was first made public on March 1st 2019 and its most recent update came out on September 1st 2022. The research team are hoping to enrol 136 patients from a single site."

Answered by AI

Are there any existing examinations that have looked into Cannabidiol's efficacy?

"Presently, there are 79 trials actively researching Cannabidiol with 16 of them in Phase 3. Of these clinical studies, many are based out of Ribeirao Preto and Sao Paulo; yet 290 other locations also have active research projects related to this substance."

Answered by AI

Are there any potential adverse effects associated with Cannabidiol usage?

"There is evidence of cannabidiol's safety, but no prior trials have been conducted to evaluate its efficacy; therefore it was assigned a score of 2."

Answered by AI

Are there still vacancies available for prospective participants in this clinical experiment?

"According to details posted on clinicaltrials.gov, this trial is currently searching for suitable applicants. It was initially published on March 1st 2019 and has been refreshed as recently as September 1st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Saskatchewan
How old are they?
18 - 65
What site did they apply to?
VA San Diego Healthcare System, San Diego, CA
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cannabidiol and Prolonged Exposure
2019. "Cannabidiol and Prolonged Exposure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03518801.
All > Ptsd Anaheim > Epidiolex
~10 spots leftby Sep 2024
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