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Sleep drug suvorexant shows promise for curbing heavy drinking in early trial

NCT ID NCT05656534

Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested whether suvorexant (Belsomra), a sleep medication, can reduce stress sensitivity and heavy drinking in 81 adults with moderate to severe alcohol use disorder. Participants took either suvorexant or a placebo for 4 weeks, and researchers measured their startle response to stress and drinking patterns. The goal was to see if blocking orexin in the brain could help people better handle stress and drink less.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Suvorexant (Belsomra)
What this could lead to
If it works, this could point toward a new way to help people with alcohol use disorder by reducing stress-related triggers for heavy drinking.
What could go wrong
This is a very early, small study (81 people) testing a single dose and 4 weeks of daily use. Results may not lead to a proven treatment, and suvorexant can cause side effects like drowsiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

81 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial.

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Conditions

The condition(s) this trial relates to.

alcohol abuse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder

Contacts and locations

Locations

  • The Ohio State University

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.