Could a sleep aid curb opioid relapse? new study tests suvorexant
NCT ID NCT04287062
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
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Nov 2020
- Finished
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Aug 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Ashley Addiction Treatment
Bel Air, Maryland, 21014, United States
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Ashley Addiction Treatment
Elkton, Maryland, 21921, United States
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Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Man Alive Inc., Lane Treatment Center
Baltimore, Maryland, 21218, United States
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