A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suvorexant, Placebo.
- Who it may be relevant to
- Registry conditions: Insomnia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Suvorexant
Oral Tablet - Drug Placebo
Oral Tablet
Primary outcome measures
- Change from Baseline in Total Sleep Time at Week 8 [Time frame: Baseline and Week 8]
- Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to approximately 10 weeks]
- Number of Participants Who Experience One or More Serious Adverse Events (SAEs) [Time frame: Up to approximately 10 weeks]
- Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 8 weeks]
Secondary outcome measures (7)
- Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8 [Time frame: Baseline and Week 8]
- Number of Participants Who are Positive for Substance Abuse at Day 1 [Time frame: Day 1]
- Number of Participants Who are Positive for Substance Abuse at Day 4 [Time frame: Day 4]
- Number of Participants Who are Positive for Substance Abuse at Week 2 [Time frame: Week 2]
- Number of Participants Who are Positive for Substance Abuse at Week 4 [Time frame: Week 4]
- Number of Participants Who are Positive for Substance Abuse at Week 8 [Time frame: Week 8]
- Number of Participants with Positive Urine Drug Screen [Time frame: Day 1, Day 4, Week 2, Week 4, Week 8]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Yale University School of Medicine ( Site 1003) — New Haven
- CenExel iResearch, LLC ( Site 2010) — Savannah
- Johns Hopkins University ( Site 1001) — Baltimore
- Hassman Research Institute Marlton Site ( Site 2005) — Marlton
- The Rivus Wellness & Research Institute ( Site 2014) — Oklahoma City
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( — Philadelphia
- Butler Hospital ( Site 1002) — Providence
- Medical University of South Carolina ( Site 1005) — Charleston
- … and 3 more centers
Identifiers
NCT: NCT06655883 · 4305-098 · MK-4305-098