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Could a sleep drug curb heavy drinking? new trial investigates

NCT ID NCT07701928

Disease control Sponsor: Sterling McPherson 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether the sleep medication daridorexant can help people with alcohol use disorder and insomnia drink less. Participants take either daridorexant or a placebo nightly for 12 weeks, along with brief counseling. The study tracks alcohol use through self-reports and urine tests, and measures sleep using an EEG headband. Results will show if improving sleep can also reduce heavy drinking.

What this could mean

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

Active substance
daridorexant, a sleep medication taken as a 50 mg tablet once daily at night
What this could lead to
If successful, this could point toward a new treatment that improves sleep and reduces heavy drinking in people with alcohol use disorder.
What could go wrong
This is a mid-stage trial with 205 participants, so results may not apply to everyone. The drug may not reduce drinking more than placebo, and side effects 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 205 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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 years and older

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: * DSM-5 diagnosis of an insomnia disorder (i.e., difficulty initiating/maintaining sleep, early morning awakening equal or greater than 3 nights a week for equal or greater than 3 months, daytime impairment, and exclusion of other causes) * Insomnia Severity Index (ISI) score equal or greater to 15 indicating the presence of moderate or severe insomnia * 4 or more standard drinks on 4 or more occasions in the past 30 days * Seeking insomnia and AUD treatment * Aged 18+ years * DSM-5 diagnosis of AUD * Ability to read and speak English * Breath Alcohol of 0.00 for informed consent * Ability to provide written informed consent * Non-lactating women of childbearing age using a reliable form of birth control with a negative serum pregnancy test at baseline Exclusion Criteria: * Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal * Receipt of any pharmacotherapy for sleep or AUD in the past 30 days * Current DSM-5 diagnosis of sever substance use disorder that is not currently being treated, other than nicotine * Suicide attempt in the last 2 years * Moderate hepatic impairment indicating an inability to receive the full dose of 50mg/day * History of narcolepsy or complex sleep behaviors with sedative-hypnotics * Any other medical (discernible by initial blood test) or psychiatric condition that our medical team determines would compromise safe participation

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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 Insomnia

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

  • WSU Research Clinic

    Spokane, Washington, 99202, United States

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