A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Purpose
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.
Condition
- Insomnia
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
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.
Exclusion Criteria
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Suvorexant |
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. |
|
|
Placebo Comparator Placebo |
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
|
Recruiting Locations
Houston 4699066, Texas 4736286 77043
Study Coordinator
281-369-5765
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC