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

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Insomnia

Treatments: Drug: Placebo; Drug: Suvorexant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06655883

4305-098

MK-4305-098 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Has a diagnosis of OUD and is currently in treatment for OUD.
• Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment.
• Has sleep complaints that meet Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for the diagnosis of insomnia.
• 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.

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Has current uncontrolled major co-morbid psychiatric illness including 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 non-melanoma 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 trans-meridian travel within 2 weeks prior to start of study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

Suvorexant

Experimental group

Description:

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.

Treatment:

Drug: Suvorexant

Placebo

Placebo Comparator group

Description:

Participants receive suvorexant-matching placebo for up to approximately 8 weeks.

Treatment:

Drug: Placebo