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Sleep drug may boost alcohol craving treatment in small study

NCT ID NCT05458609

Disease control Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether adding the sleep medication lemborexant (Dayvigo) to the standard alcohol craving drug naltrexone helps people with alcohol use disorder and insomnia. Eight adults took either the combination or naltrexone plus a placebo. Researchers measured alcohol cravings and sleep quality. The trial is complete but very small, so results are preliminary.

What this could mean

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

Active substance
Lemborexant (Dayvigo) and Naltrexone (Vivitrol, Revia)
What this could lead to
If it works, this combination could help people with alcohol use disorder and insomnia better manage cravings and improve sleep.
What could go wrong
This is a very small study (8 people) and results may not apply to everyone. The combination may not work better than naltrexone alone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

8 people

The number who actually took part.

Started

Feb 2023

Finished

Jan 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: * Admission to The Menninger clinic * Age 18-65 years * diagnosis of alcohol use disorder using the DSM-5 criteria confirmed with SCID-5 and * Diagnosis of insomnia using the DSM 5 criteria, confirmed with SCID-5 Exclusion Criteria: * unstable medical conditions (e.g. liver enzymes (ALT and AST) more than 3 times normal) * acute alcohol withdrawal * another drug use disorder other than nicotine and cannabis * use of either of the study medications, naltrexone or lemborexant, within the last 30 days * Use of any opioid medication within the past 10 days * Use of scheduled benzodiazepines and hypnotics * Breathalyzer positive for alcohol * Known sensitivity to naltrexone or lemborexant * Pregnant or breastfeeding * Diagnosis of narcolepsy. The presence of other psychiatric illnesses, use of other psychotropic medications, and stable medical conditions will not be excluded.

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Conditions

The condition(s) this trial relates to.

alcohol abuse insomnia

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 Menninger Clinic

    Houston, Texas, 77035, United States

More trials for these conditions

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