A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
NCT ID: NCT06655883
Last Updated: 2026-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-10-09
2027-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Suvorexant
Participants receive 10 mg of suvorexant for the first three nights, increased to 20 mg of suvorexant nightly thereafter at the investigator's discretion, for up to approximately 8 weeks.
Suvorexant
Oral Tablet
Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks.
Placebo
Oral Tablet
Interventions
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Suvorexant
Oral Tablet
Placebo
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Johns Hopkins University ( Site 1001)
Baltimore, Maryland, United States
The Rivus Wellness & Research Institute ( Site 2014)
Oklahoma City, Oklahoma, United States
Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
Philadelphia, Pennsylvania, United States
Butler Hospital ( Site 1002)
Providence, Rhode Island, United States
Medical University of South Carolina ( Site 1005)
Charleston, South Carolina, United States
Adams Clinical Dallas ( Site 2007)
DeSoto, Texas, United States
Memorial Hermann Village ( Site 2001)
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-4305-098
Identifier Type: OTHER
Identifier Source: secondary_id
4305-098
Identifier Type: -
Identifier Source: org_study_id
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