Suvorexant for Opioid/Stimulant Co-use

Phase 2

Completed

• Conditions: Opioid Use Disorder; Stimulant Use Disorder
• Interventions: Drug: Suvorexant (dual orexin receptor antagonist); Drug: Placebo

• Registration Number: NCT05546515
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Study Start: 2022-12-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Ages 18-65,
2. Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
3. Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
4. Willingness to engage with study protocol
5. Use of birth control (as appropriate)

Exclusion criteria:

1. Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
2. Pregnant or breastfeeding
3. Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
4. Moderate or severe substance use disorder other than opioid or stimulant use disorder
5. SUVO consumption in the last 30 days
6. Use of medications that are contraindicated with the study
7. Past 30-day suicidal behavior
8. Use of continuous positive airway pressure (CPAP) device for sleep apnea

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suvorexant	Suvorexant (dual orexin receptor antagonist)	20mg Suvorexant
Placebo	Placebo	Placebo oral capsules

Primary Outcome Measures

Name	Time	Method
Opioid use	Up to 30 days post-randomization	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)
Cocaine use	Up to 30 days post-randomization	Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States