drugset / Trial / NCT07214207

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

NCT07214207

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-12-04
Primary completion
2030-09
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Suvorexant Small molecule 10 mg Oral