Suvorexant to treat insomnia in people with opioid use disorder.

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

This trial tests whether suvorexant helps people with opioid use disorder fall asleep faster and stay asleep longer compared with placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Merck Sharp & Dohme LLC (Industry-sponsored)
• Locations: 10 sites (New Haven, Connecticut and 9 other locations)
• Trial ID: NCT06655883 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled trial enrolls adults with DSM-5 opioid use disorder who are on a stable dose of medications for opioid use disorder and meet criteria for insomnia disorder. Participants will be randomized to receive suvorexant or matching placebo and will keep a regular bedtime between 8 PM and 1 AM for the study duration. The study measures safety and tolerability of suvorexant and compares sleep duration and continuity outcomes versus placebo. Treatment requires participants to have been off illicit opioids for at least four weeks prior to entry and excludes those with uncontrolled major psychiatric illness.

Who should consider this trial

Good fit: Adults with DSM-5 opioid use disorder confirmed by structured interview, on a verified stable dose of MOUD, meeting insomnia disorder criteria, keeping a regular bedtime (8 PM–1 AM), and off opioids for at least four weeks are ideal candidates.

Not a fit: People with uncontrolled major psychiatric illnesses, recent opioid use (under four weeks), unstable MOUD dosing, or contraindications to suvorexant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, suvorexant could improve sleep duration and continuity for people with opioid use disorder, which may help daytime functioning and potentially reduce sleep-related relapse risk.

How similar studies have performed: Suvorexant has shown efficacy for primary insomnia in prior trials, but its use specifically in people with opioid use disorder is relatively novel and less studied.

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.

Where this trial is running

New Haven, Connecticut and 9 other locations

• Yale University School of Medicine ( Site 1003) — New Haven, Connecticut, United States (Recruiting)
• CenExel iResearch, LLC ( Site 2010) — Savannah, Georgia, United States (Recruiting)
• Johns Hopkins University ( Site 1001) — Baltimore, Maryland, United States (Recruiting)
• Hassman Research Institute Marlton Site ( Site 2005) — Marlton, New Jersey, United States (Recruiting)
• The Rivus Wellness & Research Institute ( Site 2014) — Oklahoma City, Oklahoma, United States (Recruiting)
• Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006) — Philadelphia, Pennsylvania, United States (Recruiting)
• Butler Hospital ( Site 1002) — Providence, Rhode Island, United States (Recruiting)
• Medical University of South Carolina ( Site 1005) — Charleston, South Carolina, United States (Recruiting)
• Adams Clinical Dallas ( Site 2007) — DeSoto, Texas, United States (Recruiting)
• Memorial Hermann Village ( Site 2001) — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Toll Free Number

Conditions Insomnia