A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Insomnia

In brief

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

Key facts

Study ID

NCT06655883

Run by

Merck Sharp & Dohme LLC

People needed

300

Starts

2025-10-09

Expected to finish

2027-06-24

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale University School of Medicine ( Site 1003) — New Haven, Connecticut, United States (enrolling)
• CenExel iResearch, LLC ( Site 2010) — Savannah, Georgia, United States (enrolling)
• Johns Hopkins University ( Site 1001) — Baltimore, Maryland, United States (enrolling)
• Hassman Research Institute Marlton Site ( Site 2005) — Marlton, New Jersey, United States (enrolling)
• The Rivus Wellness & Research Institute ( Site 2014) — Oklahoma City, Oklahoma, United States (enrolling)
• Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006) — Philadelphia, Pennsylvania, United States (enrolling)
• Butler Hospital ( Site 1002) — Providence, Rhode Island, United States (enrolling)
• Medical University of South Carolina ( Site 1005) — Charleston, South Carolina, United States (enrolling)
• Adams Clinical Dallas ( Site 2007) — DeSoto, Texas, United States (enrolling)
• Memorial Hermann Village ( Site 2001) — Houston, Texas, United States (enrolling)
• VCU Institute for Drug and Alcohol Studies ( Site 1004) — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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