NCT05145764 Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
| NCT ID | NCT05145764 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Suvorexant |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-03-30 |
| Primary Completion | 2026-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine/naloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine/naloxone and transitioned to extended-release buprenorphine).
Eligibility Criteria
Inclusion Criteria: * Aged 18-65 * Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids * Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues * Interest in being maintained on buprenorphine for OUD * Plans to reside in current area for study period * Achieving a study maintenance dose of \>=8mg sublingual buprenorphine/naloxone * Willing to comply with study protocol * Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation Exclusion Criteria: * Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels) * Pregnant or breast feeding * Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol/benzodiazepine physical dependence * Have a known allergy to the study medications * Past 30-day prescri