Suvorexant for Opioid Use Disorder

Phase 2

Waitlist Available

Led By Mark K Greenwald, PhD

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

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

Must have

Males and non-pregnant females who agree to medically accepted birth control for the duration of the study

Age 18-70 years old

Must not have

Medications including anxiolytics, hypnotics (both prescription and OTC), sedating antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H4 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented

Chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sleep efficiency is measured on the evening of the first medication dose

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial will study the effects of suvorexant on sleep efficiency and opioid abstinence in 180 participants with opioid use disorder.

Who is the study for?

This trial is for adults aged 18-70 with opioid use disorder who have completed detox. They must not be pregnant and agree to birth control. Excluded are those with chronic illnesses, unstable conditions, certain psychiatric diseases, or using disallowed medications.

What is being tested?

The study tests if suvorexant improves sleep efficiency and helps patients abstain from opioids in outpatient settings. It also examines if better sleep contributes to staying off opioids. Participants will either receive suvorexant or a placebo.

What are the potential side effects?

While the side effects of suvorexant aren't detailed here, common ones may include drowsiness, headache, dizziness, dry mouth and potential next-day impairment.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use birth control during the study.

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I am not taking any medications that cause drowsiness or stimulate my system.

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I do not have chronic kidney failure, liver disease, seizures, or dementia.

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I have sleep issues like sleep apnea or restless legs that disturb my sleep.

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I do not have psychosis, bipolar disorder, or PTSD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sleep efficiency is measured on the evening of the first medication dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sleep efficiency is measured on the evening of the first medication dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and sleep efficiency is measured on the evening of the first medication dose for reporting.