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Could a sleep aid curb opioid relapse? new study tests suvorexant

NCT ID NCT04287062

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study looked at whether a sleep medication called suvorexant can improve sleep and reduce stress in people recovering from opioid addiction. About 138 participants on medications like methadone or buprenorphine were given either suvorexant or a placebo for 8 weeks. The goal was to see if better sleep and lower stress could help prevent relapse.

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 that blocks orexin, a brain chemical involved in wakefulness)
What this could lead to
If it works, this could point toward a way to improve sleep and lower stress in people recovering from opioid addiction, potentially reducing relapse risk.
What could go wrong
This is a Phase 2 trial with a moderate size (138 participants), so results may not apply to everyone. The drug may not improve sleep or stress significantly, and side effects like daytime drowsiness 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

138 people

The number who actually took part.

Started

Nov 2020

Finished

Aug 2025

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 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: * Between the ages of 21-65, inclusive. * Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score \>5. * Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD. * Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study. * At least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care. * Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments. * Use of birth control throughout study. * Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation. Exclusion Criteria: * Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others). * Current moderate to severe substance use disorder other than OUD. * Current illicit stimulant use, including cocaine and methamphetamine. * Pregnant or breast feeding. * Have a known allergy to the study medications. * Past 30-day prescribed use of suvorexant. * Current use of a benzodiazepine or other schedule IV medication for insomnia. * Use of Cytochrome P450 3A inhibitors. * Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history * Apnea-hypopnea index \> 30. * Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis. * Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). * Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).

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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.

Contacts and locations

Locations

  • Addiction Treatment Services at Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Ashley Addiction Treatment

    Bel Air, Maryland, 21014, United States

  • Ashley Addiction Treatment

    Elkton, Maryland, 21921, United States

  • Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Man Alive Inc., Lane Treatment Center

    Baltimore, Maryland, 21218, United States

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