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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post treatment (16-weeks), 1-month follow-up (20-weeks), 3-month follow-up (28-weeks)

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.