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Could a sleep pill curb alcohol cravings? new trial investigates

NCT ID NCT07214207

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether suvorexant, a sleep medication, can help people with alcohol use disorder drink less and handle stress better. About 250 adults who want to cut back on alcohol will take either the drug or a placebo nightly for 8 weeks. Researchers will track drinking habits, cravings, and stress responses through lab visits and daily smartphone reports.

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), a sleep medication
What this could lead to
If it works, this could point toward a new treatment option for alcohol use disorder that also helps with stress-related drinking.
What could go wrong
This is a mid-stage trial with 250 people, so results are not yet proven. The drug may not reduce drinking more than a placebo, and side effects like daytime sleepiness are possible.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

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: * 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 Exclusion Criteria: * Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders; * Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder; * Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder; * Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women); * Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants); * Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined by the study physician; * Current use of strong or moderate inhibitors of CYP3A liver enzymes; * Current use of strong CYP3A inducers; * Current use of digoxin; * Liver function tests more than 3 times the upper limit of normal or elevated bilirubin; * Engages in night shift work; * Smoke 10 or more cigarettes (or electronic equivalent) per day and are thus susceptible to acute nicotine withdrawal during lab visits; * Obesity as defined by a body-mass index (BMI) equal or greater than 30, as calculated from weight and height self-report; * Clinically significant alcohol withdrawal symptoms the day of the lab sessions, defined as a score \>10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar); * Unwilling/unable to sign the informed consent document; * Under 18 years old or over 65 years old at the time of enrollment; * Have attempted suicide in the past 3 years and/or have current suicidal ideation determined as greater than moderate via the Columbia Suicide Severity Rating Scale (C-SSRS)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

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