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New sleep drug could help those battling opioid addiction

NCT ID NCT06655883

Symptom relief Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 4 times

Summary

This study tests whether suvorexant, a sleep medication, can help people with opioid use disorder fall asleep and stay asleep. About 300 participants will receive either suvorexant or a placebo. The goal is to see if the drug improves total sleep time and is safe to use.

What this could mean

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

Active substance
suvorexant
What this could lead to
If it works, this could provide a safe, effective sleep aid for people with opioid use disorder who struggle with insomnia.
What could go wrong
This is a phase 3 trial, but insomnia treatments often have mixed results. Suvorexant may not work better 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 3

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

Participants

About 300 people

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

Started

Oct 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 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: The main inclusion criteria include but are not limited to the following: * Has a primary diagnosis of OUD according to Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5), and confirmed through the Mini International Neuropsychiatric Interview (MINI). * Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment. * Meets DSM-5 criteria for the diagnosis of Insomnia Disorder * Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study. * Has not used opioids for a period of at least 4 weeks before entering the study. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has current uncontrolled major co-morbid psychiatric illness including major depressive disorder, bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features. * Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (EDS), or primary hypersomnia. * Is at imminent risk of self-harm. * Has a known history of stroke that may confound the diagnosis of insomnia. * Has a clinically significant movement disorder such as akinesia. * Has a history of hepatitis or live disease. * Has habitual use of central nervous system (CNS)-depressants or stimulants that may be responsible for the participant's disturbed sleep. * Has a history of malignancy, ≤3 years prior to start of study, with the exception of nonmelanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix. * Has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications. * Has donated blood products or had phlebotomy within 8 weeks prior to start of study. * Has a history of transmeridian travel within 2 weeks prior to start of study.

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Conditions

The condition(s) this trial relates to.

insomnia opiate dependence

As listed by the trial registrant

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

Insomnia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adams Clinical Dallas ( Site 2007)

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Bradenton Research Center ( Site 2021)

    RECRUITING

    Bradenton, Florida, 34205, United States

  • Butler Hospital ( Site 1002)

    RECRUITING

    Providence, Rhode Island, 02906, United States

  • CenExel iResearch, LLC ( Site 2010)

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Cenexel CNS ( Site 2012)

    RECRUITING

    Garden Grove, California, 92845, United States

  • Hassman Research Institute Marlton Site ( Site 2005)

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Johns Hopkins University ( Site 1001)

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Medical University of South Carolina ( Site 1005)

    RECRUITING

    Charleston, South Carolina, 29403, United States

  • Memorial Hermann Village ( Site 2001)

    RECRUITING

    Houston, Texas, 77043, United States

  • Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Rivus Wellness & Research Institute ( Site 2014)

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • VCU Institute for Drug and Alcohol Studies ( Site 1004)

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Yale University School of Medicine ( Site 1003)

    RECRUITING

    New Haven, Connecticut, 06520, United States

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