Suvorexant for Opioid/Stimulant Co-use

Study Overview
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Brief Summary
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This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.

Detailed Description
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This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.

Official Title
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Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)

Conditions
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Opioid Use Disorder, Stimulant Use Disorder

Intervention / Treatment
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* Drug: Suvorexant (dual orexin receptor antagonist)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-65, Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days Willingness to engage with study protocol Use of birth control (as appropriate) Exclusion criteria: Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO Pregnant or breastfeeding Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications Moderate or severe substance use disorder other than opioid or stimulant use disorder SUVO consumption in the last 30 days Use of medications that are contraindicated with the study Past 30-day suicidal behavior Use of continuous positive airway pressure (CPAP) device for sleep apnea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suvorexant<br>20mg Suvorexant | Drug: Suvorexant (dual orexin receptor antagonist)<br>* Participants will be prescribed up to 30 days of SUVO.<br>|
| Placebo Comparator: Placebo<br>Placebo oral capsules | Drug: Placebo<br>* Participants will be prescribed up to 30 days of placebo medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no) | Up to 30 days post-randomization | 
| Cocaine use | Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index total score | Insomnia severity index total scores at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization | 
| Total sleep time | Minutes of total sleep time at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization | 
| Visual Analog Rating (0-100) of Opioid Craving | Opioid craving, as measured via an average score on visual analog scales (VAS), at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization | 
| Visual Analog Rating (0-100) of Cocaine Craving | Cocaine craving, as measured via an average score on visual analog scales (VAS), collected at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization | 
| Perceived Stress Scale Total Score | Perceived stress, measured by the Perceived Stress Scale total score at scheduled study visits up to 30 days post-randomization. | Up to 30 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orexin receptor antagonist, Suvorexant, Cocaine, Opioid, Opiate, Heroin, Fentanyl, Nonmedical opioid use, Methadone, Buprenorphine, Suboxone, Polysubstance use, Co-use, Substance-related disorders, Narcotic-related disorders, Chemically-induced disorders, Sleep, Stress, Opioid-related disorders, Stimulant-related disorders, Cocaine use disorder