RECRUITING

Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-03-30
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05145764

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-65
  2. * Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids
  3. * Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues
  4. * Interest in being maintained on buprenorphine for OUD
  5. * Plans to reside in current area for study period
  6. * Achieving a study maintenance dose of \>=8mg sublingual buprenorphine/naloxone
  7. * Willing to comply with study protocol
  8. * Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation
  1. * Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels)
  2. * Pregnant or breast feeding
  3. * Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol/benzodiazepine physical dependence
  4. * Have a known allergy to the study medications
  5. * Past 30-day prescribed use of suvorexant for the indication of insomnia
  6. * Current benzodiazepine or other prescribed medication for the indication of insomnia
  7. * Urine sample testing positive for benzodiazepine at screening and admission to residential treatment
  8. * Current narcolepsy, restless leg syndrome or sleep paralysis
  9. * High risk for current sleep apnea
  10. * Current (past 30-day) suicidal behaviors
  11. * Severe hepatic or renal impairment
  12. * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
  13. * Total bilirubin \>2x ULN
  14. * Creatinine \>1.5x ULN
  15. * Past year clinically-significant psychiatric condition judged to interfere with study participation
  16. * Lack of access to stable housing (necessary for electronic pill dispenser charging)
  17. * Have circumstances that would interfere with study participation (e.g., impending jail)

Contacts and Locations

Study Contact

Andrew S Huhn, Ph.D.
CONTACT
410-550-1971
ahuhn1@jhu.edu
Kelly E Dunn, Ph.D.
CONTACT
410-550-2254
kdunn9@jhmi.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30
Study Completion Date2025-08

Study Record Updates

Study Start Date2022-03-30
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Opioid use disorder
  • Insomnia
  • Suvorexant
  • Fentanyl
  • Buprenorphine

Additional Relevant MeSH Terms

  • Suvorexant
  • Placebo
  • Opioid Use Disorder