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Orexin Antagonist

Suvorexant for Opioid Use Disorder

Phase 2

Recruiting

Led By Andrew S Huhn, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD

Between the ages of 21-65, inclusive.

Must not have

Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis

Past 30-day prescribed use of suvorexant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)

Summary

This trial is investigating whether the orexin neurotransmitter system is linked to sleep disturbance and stress in opioid use disorder patients who are early in their recovery and on medication assisted treatment.

Who is the study for?

This trial is for adults aged 21-65 with opioid use disorder who are in early recovery and experiencing sleep disturbances. They must be on medication-assisted treatments like methadone, buprenorphine, or XR-NTX, have abstained from illicit opioids for two weeks, and agree to weekly visits and daily monitoring. Exclusions include unstable serious mental illnesses, other severe substance disorders, certain medication allergies or uses, pregnancy/breastfeeding, specific sleep disorders like narcolepsy or severe apnea.

What is being tested?

The study tests whether suvorexant can improve sleep and reduce stress-related relapse behaviors in patients recovering from opioid addiction compared to a placebo. Participants maintained on different medications (methadone/buprenorphine/XR-NTX) will randomly receive either suvorexant or a placebo while their sleep patterns and stress levels are monitored.

What are the potential side effects?

Suvorexant may cause drowsiness during the day, headaches, dizziness when standing up too fast due to low blood pressure (orthostatic hypotension), unusual dreams or nightmares; less commonly it might lead to temporary muscle weakness (cataplexy) or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently in a treatment program for opioid use disorder.

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I am between 21 and 65 years old.

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I have had trouble sleeping in the past month.

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I have had trouble sleeping in the past month.

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I am willing to follow a specific medication plan with methadone or XR-NTX for the study.

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I am willing to follow a specific medication plan for the study.

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I am between 21 and 65 years old.

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I am currently in a treatment program for opioid use disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking steroids or medications that affect my hormone control system.

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I have been prescribed suvorexant in the last 30 days.

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I have been diagnosed with narcolepsy, sleep paralysis, or restless leg syndrome.

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I am currently taking medication for sleep that is classified as schedule IV.

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I am not taking any medications that affect Cytochrome P450 3A.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial) for reporting.