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EXHIT ENTRE Comparative Effectiveness Trial

NCT04345718 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2025-12-09

No results posted yet for this study

Summary

This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.

Conditions

  • Substance Use Disorder
  • Opioid Use Disorder, Moderate
  • Opioid Use Disorder, Severe

Interventions

DRUG

Extended Release Buprenorphine

XR-BUP administration prior to hospital discharge will increase engagement in OUD care on the 34th day following hospital discharge more than is currently afforded by ACS TAU approaches (e.g., methadone, SL-BUP, and naltrexone).

DRUG

Treatment as Usual

Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.

Sponsors & Collaborators

  • Hennepin Healthcare Research Institute

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Gavin Bart

    lead OTHER

Principal Investigators

  • Gavin Bart, MD,PhD · Hennepin Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2025-08-27
Completion
2025-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345718 on ClinicalTrials.gov