Overview

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)