Suvorexant for Treatment of AUD and PTSD
Recruiting
Phase 2
Interventional Study
Alcohol Use Disorder (AUD)
Post Traumatic Stress Disorder (PTSD)
Insomnia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 76 (estimated)
- Sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Other
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About This Trial
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age between 21 and 65.
* Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.
* Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score \> 30.
* Intrinsic motivatio…
Contacts