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Can a sleep pill boost success in opioid treatment?

NCT ID NCT05145764

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study tests whether adding the sleep medication suvorexant to standard buprenorphine treatment can improve sleep and medication adherence in people with opioid use disorder who have recently used fentanyl. Participants first stay in a residential setting for five days to start buprenorphine, then continue treatment as outpatients for three weeks. The trial compares suvorexant against a placebo, measuring sleep quality and how consistently participants take their buprenorphine.

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, adding suvorexant to standard buprenorphine treatment could improve sleep and help people stick with their recovery medication, potentially reducing relapse.
What could go wrong
This is a small, early-stage trial, so results may not hold up in larger studies. Suvorexant can cause side effects like drowsiness or unusual sleep behaviors, and its benefit for opioid use disorder is unproven.

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

76 people

The number who actually took part.

Started

Mar 2022

Finished

Aug 2026

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: * Aged 18-65 * Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids * Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues * Interest in being maintained on buprenorphine for OUD * Plans to reside in current area for study period * Achieving a study maintenance dose of \>=8mg sublingual buprenorphine/naloxone * Willing to comply with study protocol * Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation Exclusion Criteria: * Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels) * Pregnant or breast feeding * Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol/benzodiazepine physical dependence * Have a known allergy to the study medications * Past 30-day prescribed use of suvorexant for the indication of insomnia * Current benzodiazepine or other prescribed medication for the indication of insomnia * Urine sample testing positive for benzodiazepine at screening and admission to residential treatment * Current narcolepsy, restless leg syndrome or sleep paralysis * High risk for current sleep apnea * Current (past 30-day) suicidal behaviors * Severe hepatic or renal impairment * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN) * Total bilirubin \>2x ULN * Creatinine \>1.5x ULN * Past year clinically-significant psychiatric condition judged to interfere with study participation * Lack of access to stable housing (necessary for electronic pill dispenser charging) * Have circumstances that would interfere with study participation (e.g., impending jail)

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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

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

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