Actively Recruiting
A Study to Evaluate the Safety and Effectiveness of Suvorexant for Insomnia in Adults With Opioid Use Disorder
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-15
300
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study people with opioid use disorder (OUD) who often have difficulty falling asleep or staying asleep. The goal is to evaluate the safety and tolerability of suvorexant, a medication being studied for insomnia in this group. Researchers also want to find out if suvorexant helps people with OUD sleep longer compared to those taking a placebo, which looks like the medicine but contains no active drug. Participants in the study will be randomly assigned to receive either suvorexant or a matching placebo for about 8 weeks. Those taking suvorexant will start with 10 mg for the first three nights, then may increase to 20 mg nightly as decided by the study doctor. The study is designed as a double-blind, meaning neither participants nor researchers know who receives the medicine or placebo during the trial. During the study, participants will have their sleep time and wakefulness measured at the start and after 8 weeks. Researchers will monitor any side effects or serious events throughout the approximately 10-week period. Drug use will be assessed multiple times with urine tests. The study runs from October 2025 to June 2027, with safety and sleep outcomes carefully tracked to learn about suvorexant's effects in people with OUD-related insomnia.
CONDITIONS
Brief Title
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Primary diagnosis of opioid use disorder confirmed by DSM-5 and MINI interview
- On a stable dose of medications for opioid use disorder treatment
- Meets DSM-5 criteria for insomnia disorder
- Has a regular bedtime between 8 PM and 1 AM and willing to maintain it during the study
- Has not used opioids for at least 4 weeks before starting the study
You will not qualify if you...
- Current uncontrolled major psychiatric illness such as major depression, bipolar disorder, schizophrenia, or psychotic features
- Diagnosis or history within 5 years of narcolepsy, sleep paralysis, severe limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm disorder, parasomnia, REM behavior disorder, significant sleep-related breathing disorder, excessive daytime sleepiness, or primary hypersomnia
- Imminent risk of self-harm
- Known history of stroke that may affect insomnia diagnosis
- Clinically significant movement disorders like akinesia
- History of hepatitis or liver disease
- Habitual use of CNS depressants or stimulants causing sleep disturbance
- History of cancer within 3 years except certain skin, prostate, or cervical cancers
- History of hypersensitivity to more than 3 drug classes
- Donated blood or had phlebotomy within 8 weeks before study
- Transmeridian travel within 2 weeks before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 8 weeks
Participants receive either suvorexant or a matching placebo nightly to treat insomnia for up to approximately 8 weeks.
Weekly visits for up to 8 weeks
Duration - Up to approximately 10 weeks
Participants are monitored for safety and adverse events for up to approximately 10 weeks from the start of treatment.
Visits at approximately Week 8 and Week 10
Trial Site Locations
Total: 11 locations
1
Yale University School of Medicine ( Site 1003)
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
CenExel iResearch, LLC ( Site 2010)
Savannah, Georgia, United States, 31405
Actively Recruiting
3
Johns Hopkins University ( Site 1001)
Baltimore, Maryland, United States, 21224
Actively Recruiting
4
Hassman Research Institute Marlton Site ( Site 2005)
Marlton, New Jersey, United States, 08053
Actively Recruiting
5
The Rivus Wellness & Research Institute ( Site 2014)
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
6
Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Butler Hospital ( Site 1002)
Providence, Rhode Island, United States, 02906
Actively Recruiting
8
Medical University of South Carolina ( Site 1005)
Charleston, South Carolina, United States, 29403
Actively Recruiting
9
Adams Clinical Dallas ( Site 2007)
DeSoto, Texas, United States, 75115
Actively Recruiting
10
Memorial Hermann Village ( Site 2001)
Houston, Texas, United States, 77043
Actively Recruiting
11
VCU Institute for Drug and Alcohol Studies ( Site 1004)
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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