Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

August 5, 2026 updated by: Johns Hopkins University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will enroll persons with opioid use disorder (N=120) who have recent fentanyl exposure (as assessed via urinalysis testing). Participants will be randomized to receive suvorexant or placebo for the duration of the study enrollment, which will serve as the between-groups experimental comparison. The study will consist of a brief (5 day) residential phase and 3-week outpatient phase. During the residential phase, all participants will be briefly maintained on a short acting opioid prior to induction onto sublingual (SL) buprenorphine (using either the buprenorphine or buprenorphine/naloxone product). At the end of the 5-day residential period, participants will be discharged to complete the ~3-week outpatient phase. During the outpatient period all participants will be maintained on SL buprenorphine/naloxone and continue to receive suvorexant or placebo, and at the end of the study participants will receive an injection of XR-buprenorphine (Sublocade). All buprenorphine procedures will be open label and will follow standard-of-care practices. Study medication during the outpatient period will be managed using an automated pill dispenser. Data collection will consist of forehead-based EEG monitoring, wrist-worn actigraphy/photoplethysmography, and questionnaires delivered during study visits or via cell-phone based ecological momentary assessments.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suvorexant
Nightly dosing of suvorexant
Drug: Suvorexant
Encapsulated suvorexant (matched for color, weight, and size)
Placebo Comparator: Placebo
Nightly dosing of placebo
Drug: Placebo
Encapsulated placebo (matched for color, weight, and size)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: 3 nights during the initial residential phase and 1 night at the end of outpatient treatment
Duration of nightly total sleep time in minutes, as measured by electroencephalography (EEG) and supplemented by actigraphy/photoplethysmography (e.g., if EEG malfunctions).
3 nights during the initial residential phase and 1 night at the end of outpatient treatment
Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment
Time Frame: 25 days across residential and outpatient treatment
Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment.
25 days across residential and outpatient treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Andrew S Huhn, Ph.D., 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 Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Actual)

August 3, 2026

Study Completion (Actual)

August 3, 2026

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00301337
  • UH3DA048734 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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