RecruitingPhase 3NCT06655883

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder


Sponsor

Merck Sharp & Dohme LLC

Enrollment

300 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Suvorexant for people with insomnia. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSuvorexant

Oral Tablet

DRUGPlacebo

Oral Tablet


Locations(11)

Yale University School of Medicine ( Site 1003)

New Haven, Connecticut, United States

CenExel iResearch, LLC ( Site 2010)

Savannah, Georgia, United States

Johns Hopkins University ( Site 1001)

Baltimore, Maryland, United States

Hassman Research Institute Marlton Site ( Site 2005)

Marlton, New Jersey, 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

VCU Institute for Drug and Alcohol Studies ( Site 1004)

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06655883


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