RecruitingSuvorexantPlaceboOpioid Use Disorder
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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 prescribed use of suvorexant for the indication of insomnia
- ✕ Current benzodiazepine or other prescribed medication for the indication of insomnia
- ✕ Urine sample testing positive for benzodiazepine at screening and admission to residential treatment
- ✕ Current narcolepsy, restless leg syndrome or sleep paralysis
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT05145764 · last updated 2025-08-11