Phase 2
N=13
Suvorexant for Opioid/Stimulant Co-use
Opioid Use Disorder · Stimulant Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05546515 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Opioid Use: Proportion of Positive Urine Drug Screens (UDS) — 0.83; 0.67 Proportion of urine drug screens
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Suvorexant (dual orexin receptor antagonist) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Use: Proportion of Positive Urine Drug Screens (UDS) |
0.83; 0.67 | — |
| PRIMARY Cocaine Use: Proportion of Positive UDS Screens |
0.83; 0.97 | — |
| SECONDARY Insomnia Severity Regression Slope |
-0.55; -0.16 | — |
| SECONDARY Total Sleep Time (TST) Regression Slope |
11.68; 9.37 | — |
| SECONDARY Opioid Craving Visual Analog Scale (VAS) Regression Slope |
-1.76; -1.46 | — |
| SECONDARY Cocaine Craving Visual Analog Scale (VAS) Regression Slope |
-0.60; -0.71 | — |
| SECONDARY Perceived Stress Scale Regression Slope |
-0.19; 0.19 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05546515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.