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

NCT06655883 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 4305-098MK-4305-098
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Total Sleep Time at Week 8

  Total sleep time will be measured in a sleep laboratory by polysomnography at the participant's habitual bedtime. Change from baseline in total sleep time at Week 8 will be reported.

  Baseline and Week 8

• Number of Participants Who Experience One or More Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 10 weeks

• Number of Participants Who Experience One or More Serious Adverse Events (SAEs)

  An SAE is any untoward medical occurrence that at any dose results in death, is life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is another important medical event deemed such by medical or scientific judgement.

  Up to approximately 10 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 8 weeks

Secondary Outcomes (7)

• Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8

  Baseline and Week 8

• Number of Participants Who are Positive for Substance Abuse at Day 1

  Day 1

• Number of Participants Who are Positive for Substance Abuse at Day 4

  Day 4

• Number of Participants Who are Positive for Substance Abuse at Week 2

  Week 2

• Number of Participants Who are Positive for Substance Abuse at Week 4

  Week 4

Study Arms (2)

Suvorexant

EXPERIMENTAL

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.

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

Participants receive suvorexant-matching placebo for up to approximately 8 weeks.

Drug: Placebo

Interventions

Placebo DRUG

Oral Tablet

Placebo

Suvorexant DRUG

Oral Tablet

Also known as: MK-4305

Suvorexant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (10)

Yale University School of Medicine ( Site 1003)

New Haven, Connecticut, 06520, United States

RECRUITING

CenExel iResearch, LLC ( Site 2010)

Savannah, Georgia, 31405, United States

RECRUITING

Johns Hopkins University ( Site 1001)

Baltimore, Maryland, 21224, United States

RECRUITING

Hassman Research Institute Marlton Site ( Site 2005)

Marlton, New Jersey, 08053, United States

RECRUITING

The Rivus Wellness & Research Institute ( Site 2014)

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Butler Hospital ( Site 1002)

Providence, Rhode Island, 02906, United States

RECRUITING

Medical University of South Carolina ( Site 1005)

Charleston, South Carolina, 29403, United States

RECRUITING

Adams Clinical Dallas ( Site 2007)

DeSoto, Texas, 75115, United States

RECRUITING

Memorial Hermann Village ( Site 2001)

Houston, Texas, 77043, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: October 9, 2025
• Primary Completion (Estimated): June 24, 2027
• Study Completion (Estimated): June 24, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (10)