Clinical Trial

Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are: * Is SUV effective for AUD? * Does SUV dampen stress reactivity? * Can the researchers develop a biomarker for SUV treatment response? Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD. Participants will: * Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks. * Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG). * Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-06; most recent amendment 2025-12-05.
Status change: Not Yet Recruiting → Recruiting 2025-11-13
Trial Details
NCT Number NCT07214207
Lead Sponsor Ohio State University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use Disorder
Enrollment 250 participants
Start Date 2025-12-04
Primary Completion 2030-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2025-12-11