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Can a sleep aid curb alcohol cravings? early trial begins

NCT ID NCT06326684

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests whether suvorexant, a drug used for insomnia, can reduce people's motivation to drink alcohol. Thirty adults with moderate to severe Alcohol Use Disorder will receive suvorexant or a placebo, then choose between alcohol and money. Researchers will measure how often they pick alcohol and track cravings and mood. The goal is to see if blocking orexin, a brain chemical, can help control drinking.

What this could mean

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

Active substance
Suvorexant (a sleep medication) and alcohol
What this could lead to
If it works, this could point toward a new way to reduce alcohol cravings and drinking in people with Alcohol Use Disorder.
What could go wrong
This is a very early, small trial (30 people) testing a sleep drug for a new purpose. It may not reduce drinking motivation, and results may not apply to everyone.

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

About 30 people

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

Started

Jun 2024

Expected to finish

Mar 2027

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

21 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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/Exclusion Criteria: 1. Able to speak and read English. 2. Not seeking treatment at the time of the study. 3. Between the ages of 21 and 55 years. 4. Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days. 5. Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist. 6. ECG, read by cardiologist, within normal limits. 7. Body mass index of 19 - 35. 8. Birthing individuals using an effective form of birth control and not pregnant or breast feeding. 9. Judged by the medical staff to be psychiatrically and physically healthy (i.e., no current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use Disorder; no current physical diagnoses that would interfere with study participation according to study physician judgment). 10. Not currently physiologically dependent on any substances. 11. Able to abstain from alcohol during admission (i.e., not physically dependent on alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for Alcohol \[CIWA-Ar\] at screening). 12. Not currently taking any prescribed medications for a chronic condition (other than birth control). 13. No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater). 14. No contraindications/allergies to suvorexant.

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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

  • Psychopharmacology of Addiction Laboratory

    RECRUITING

    Lexington, Kentucky, 40507, United States

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