Actively Recruiting
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-06
300
Participants Needed
10
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Has a primary diagnosis of opioid use disorder (OUD) according to DSM-5 and confirmed by 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 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 study duration
- Has not used opioids for at least 4 weeks before entering the study
You will not qualify if you...
- Has uncontrolled major psychiatric illness such as major depressive disorder, bipolar disorder, schizophrenia, or any psychotic psychiatric condition
- Has diagnosis or history within 5 years of 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), REM behavior disorder, significant sleep-related breathing disorder, excessive daytime sleepiness, or primary hypersomnia
- Is at imminent risk of self-harm
- Has a known history of stroke that may affect insomnia diagnosis
- Has a clinically significant movement disorder such as akinesia
- Has a history of hepatitis or liver disease
- Habitually uses central nervous system depressants or stimulants affecting sleep
- Has a history of malignancy within 3 years except specified skin, prostate, or cervical cancers
- Has hypersensitivity to more than 3 chemical classes of drugs including prescription and over-the-counter medications
- Has donated blood or had phlebotomy within 8 weeks before study start
- Has traveled across time zones within 2 weeks before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 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
Research Team
T
Toll Free Number
CONTACT
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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