Suvorexant to treat insomnia in people with opioid use disorder.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cenexel CNS ( Site 2012)
  Garden Grove, California, United States Recruiting
• Yale University School of Medicine ( Site 1003)
  New Haven, Connecticut, United States Recruiting
• Bradenton Research Center ( Site 2021)
  Bradenton, Florida, 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

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.