CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 120 target
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • Aged 18-65 years
  • Meets DSM-5 criteria for opioid use disorder with physical dependence
  • Urine positive for fentanyl and/or fentanyl analogues
  • Interested in buprenorphine maintenance for OUD
Key exclusion· 14
  • Medically contraindicated for buprenorphine, XR-buprenorphine, or suvorexant
  • Pregnant or breast feeding
  • Severe DSM-5 alcohol or benzodiazepine use disorder or evidence of physical dependence
  • Known allergy to study medications

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05145764
NCT05145764Phase 2RecruitingOn TrackUpdated 10mo ago
Long Recruiting

Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl

Johns Hopkins University·interventional·Posted Dec 6, 2021·Updated Aug 11, 2025

In Brief

A Phase 2 clinical trial evaluating Suvorexant and Placebo for Suvorexant and 2 related conditions. Currently recruiting, targeting 120 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Recruiting
20222023202420252026
First PostedDec 6, 2021
Enrollment StartMar 30, 2022
Primary CompletionAug 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 4.6 years agoPrimary completion in 29 days

Interventions

Suvorexantdrug

Encapsulated suvorexant (matched for color, weight, and size)

Placebodrug

Encapsulated placebo (matched for color, weight, and size)