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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Generally medically and neurologically healthy;

• Age 18 to 65 at the time of consent;

• Willing and able to give informed consent;

• Current DSM-5 diagnosis of moderate to severe alcohol use disorder;

• Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;

• Self-reported treatment-seeking for alcohol use disorder

Locations
United States
Ohio
Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Stephanie Gorka
stephanie.gorka@osumc.edu
614-366-1027
Time Frame
Start Date: 2025-12-04
Estimated Completion Date: 2030-09
Participants
Target number of participants: 250
Treatments
Placebo_comparator: Control
Individuals will take a placebo pill daily for 8-weeks.
Experimental: Suvorexant
Individuals will take 10mg of suvorexant (Merck \& Co Inc.) daily for 8-weeks.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Leads: Ohio State University

This content was sourced from clinicaltrials.gov