Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Suvorexant

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, benzodiazepine, or stimulant 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)