At a glance
ClinicalIndex Comparison Record- ✓Age 21-65 years
- ✓DSM-5 moderate or severe AUD diagnosis in past 12 months
- ✓PTSD symptoms with PCL-5 score > 30
- ✓Motivation to reduce/quit drinking and receive PTSD treatment
- ✕Current DSM-5 substance use disorder (except alcohol, nicotine, or marijuana <moderate)
- ✕Lifetime diagnosis of schizophrenia, bipolar disorder, or psychotic disorder
- ✕Positive urine test for recreational drugs (except marijuana)
- ✕Current clinically significant alcohol withdrawal (CIWA-Ar ≥ 10)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
In Brief
A Phase 2 clinical trial evaluating Suvorexant and Placebo for Alcohol Use Disorder (AUD) and 2 related conditions. Currently recruiting, targeting 76 participants across 2 sites.
Detailed Summary
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 will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.
Study Details
Timeline
Interventions
Suvorexant is described chemically as: \[(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl\]\[5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl\]methanone. SUV's empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Each film coated tablet contains 10mg or 20mg of suvorexant.
Film coated tablet to match the active drug.