NCT05145764

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
3mo left

Started Mar 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Mar 2022Aug 2026

First Submitted

Initial submission to the registry

November 23, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

4.3 years

First QC Date

November 23, 2021

Last Update Submit

August 7, 2025

Conditions

SuvorexantPlaceboOpioid Use Disorder

Keywords

Opioid use disorderInsomniaSuvorexantFentanylBuprenorphine

Outcome Measures

Primary Outcomes (2)

  • Total Sleep Time

    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

    Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment.

    25 days across residential and outpatient treatment

Study Arms (2)

Suvorexant

EXPERIMENTAL

Nightly dosing of suvorexant

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

Nightly dosing of placebo

Drug: Placebo

Interventions

SuvorexantDRUG

Encapsulated suvorexant (matched for color, weight, and size)

Suvorexant
PlaceboDRUG

Encapsulated placebo (matched for color, weight, and size)

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersSleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Andrew S Huhn, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew S Huhn, Ph.D.

CONTACT

410-550-1971ahuhn1@jhu.edu

Kelly E Dunn, Ph.D.

CONTACT

410-550-2254kdunn9@jhmi.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 6, 2021

Study Start

March 30, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)