NCT05546515

Suvorexant for Opioid/Stimulant Co-use

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder
• Stimulant Use Disorder

Interventions

Type	Name	Description
DRUG	Suvorexant (dual orexin receptor antagonist)	Participants will be prescribed up to 30 days of SUVO.
DRUG	Placebo	Participants will be prescribed up to 30 days of placebo medication.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2022-09-19
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study