Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl
Johns Hopkins University
120 participants
Mar 30, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria17
- 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
- High risk for current sleep apnea
- Current (past 30-day) suicidal behaviors
- Severe hepatic or renal impairment
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
- Total bilirubin \>2x ULN
- Creatinine \>1.5x ULN
- Past year clinically-significant psychiatric condition judged to interfere with study participation
- Lack of access to stable housing (necessary for electronic pill dispenser charging)
- Have circumstances that would interfere with study participation (e.g., impending jail)
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Interventions
Encapsulated suvorexant (matched for color, weight, and size)
Encapsulated placebo (matched for color, weight, and size)
Locations(1)
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NCT05145764