CompletedEarly Phase 1

Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use Disorder

United States81 participantsStarted 2022-11-29

Plain-language summary

The goal of this double-blind clinical trial is to further explore if, how, and for whom orexin antagonism modifies brain-behavior stress targets in moderate to severe alcohol use disorder (AUD). The main questions it aims to answer are: * Does an acute dose of suvorexant (SUV) and/or daily use of SUV modify brain-behavior targets of AUD dysfunction? * Does daily SUV use change alcohol behavior and if so, is this change in behavior linked to brain-behavior change? Participants will be randomized to a treatment group (SUV or placebo) and protocol arm, electromyography (EMG) only or EMG+functional magnetic resonance imaging (fMRI). Participants will be asked to complete the following: * Baseline lab visit(s) that include the psychophysiological stress paradigm (EMG only or EMG+fMRI, dependent upon randomization). * Acute drug challenge where the participant will return to the lab to repeat the stress paradigm following administration of a single dose of either 10mg SUV or placebo. * Medication trial where participants will be instructed to take 10mg capsules of SUV or placebo orally each night before bedtime for 4-weeks. * Daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 4-week medication trial. * Post-treatment lab visit(s) where participants will return to the lab at the end of the medication trial and complete the same stress paradigm from baseline (EMG only or EMG+fMRI, dependent upon randomization).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-65. * Participant is able to give informed consent. * Generally medically and physically healthy as confirmed by medical history. * Meet DSM-5 diagnostic criteria for current moderate or severe AUD. * Engage in heavy alcohol use defined as drinking equal or greater than 14 standard drinks per week if male and equal or greater than 7 standard drinks per week if female. Exclusion Criteria: * Clinically significant medical or neurological condition (e.g., liver disease, narcolepsy, complex sleep behaviors, severe hepatic impairment, COPD, severe obstructive sleep apnea). * Current cognitive dysfunction (traumatic brain injury, mental retardation, organic mental syndrome, pervasive developmental disorder, or dementia). * Current use of antihistamines, strong or moderate inhibitors of CYP3A liver enzymes, strong CYP3A inducers, or digoxin. * Current or past DSM-5 diagnosis of mania, schizophrenia, psychosis, suicidality, major depressive disorder, or obsessive compulsive disorder. * Current substance use disorder other than alcohol or mild cannabis use disorder. * Treatment seeking for AUD. * Recent psychotropic medication use in the past 2 months. * Currently smokes 5 or more cigarettes (or electronic equivalent) per day. * BMI equal or greater than 35. * Engage in night-shift work. * Lack of fluency in English. * Presence of ferrous-containing metal in the body. * Inability to tolerate small, enclosed spaces. * Deafness in one or both ears. * Curr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Startle Eyeblink Electromyographic (EMG) Response to Stress With an Acute Dose of Suvorexant

Timeframe: Change from baseline to 2 hours post-ingestion of an acute dose of suvorexant.

Startle Eyeblink Electromyographic (EMG) Response to Stress With Daily Use of Suvorexant.

Timeframe: Change from baseline to post-treatment, up to 2 months.

Percentage of Heavy Drinking Days During Daily Use of Suvorexant.

Timeframe: Change from baseline to post-treatment, over the course of 4 weeks.

Trial details

NCT IDNCT05656534

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

Results submitted2025-06-20

View on ClinicalTrials.gov More Alcohol Use Disorder trials