CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 344 enrolled
Drug / intervention
Extended Release Buprenorphine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04345718
NCT04345718Phase 3Completed
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Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Comparative Effectiveness Trial of Extended Release Buprenorphine Versus Treatment as Usual for Hospitalized Patients With Opioid Use Disorder

Gavin Bart·interventional·Posted Apr 14, 2020·Updated Dec 9, 2025

In Brief

A Phase 3 clinical trial evaluating Extended Release Buprenorphine and Treatment as Usual for Substance Use Disorder and 2 related conditions. Completed, enrolled 344 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubstance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
CountriesUnited States
CollaboratorsHennepin Healthcare Research Institute, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 14, 2020
Enrollment StartAug 9, 2021
Primary CompletionAug 27, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.2 years ago

Interventions

Extended Release Buprenorphinedrug

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).

Treatment as Usualdrug

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