At a glance
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Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo
In Brief
A Phase 2 clinical trial evaluating Suvorexant 20 mg and Placebo oral tablet for Alcohol Use Disorder (AUD). Completed, enrolled 26 participants across 1 site.
Detailed Summary
The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of \> 5 versus \<5. Subjects were also stratified by sex.
Study Details
Timeline
Interventions
Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit
Single-dose administration of placebo given on an inpatient clinical research unit