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Suvorexant for Opioid Use Disorder

Phase 2

Recruiting

Led By Andrew S Huhn, Ph.D.

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Achieving a study maintenance dose of >=8mg sublingual buprenorphine/naloxone

Aged 18-65

Must not have

Current narcolepsy, restless leg syndrome or sleep paralysis

Current benzodiazepine or other prescribed medication for the indication of insomnia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 nights during the initial residential phase and 1 night at the end of outpatient treatment

Summary

This trial will test if suvorexant, a medication that helps with sleep, is better than placebo in people with opioid use disorder who have recently been exposed to fentanyl.

Who is the study for?

This trial is for adults aged 18-65 with opioid use disorder, specifically those who have used fentanyl recently. Participants must be interested in buprenorphine treatment for their condition and able to follow the study's rules. They should not have significant medical conditions that could interfere with the trial, nor plans to move away during the study period.

What is being tested?

The trial tests if suvorexant helps people with opioid use disorder when added to buprenorphine therapy compared to a placebo. It starts with a 5-day stay where participants stabilize on buprenorphine/naloxone, followed by a 3-week outpatient phase including extended-release buprenorphine.

What are the potential side effects?

Suvorexant may cause drowsiness, headaches, dizziness, dry mouth or abnormal dreams. Since it's being tested alongside buprenorphine (which can also cause side effects like nausea and constipation), monitoring will be important.

Eligibility Criteria

Inclusion Criteria

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

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I am taking a maintenance dose of 8mg or more of sublingual buprenorphine/naloxone.

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have narcolepsy, restless leg syndrome, or sleep paralysis.

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I am currently taking medication for insomnia.

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I cannot take certain medications due to medical reasons.

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My liver and kidney functions are within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 nights during the initial residential phase and 1 night at the end of outpatient treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 nights during the initial residential phase and 1 night at the end of outpatient treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 nights during the initial residential phase and 1 night at the end of outpatient treatment for reporting.