Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Description

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).

Conditions

Suvorexant, Placebo, Opioid Use Disorder

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Condition
Suvorexant
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Andrew S Huhn, Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-08