Buprenorphine Induction and Naloxone Distribution Program-Combined With Warm Hand-Off Referral to Continued Treatment

NCT ID: NCT06087991

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a collaboration between the University of Utah and Castleview Hospital in Price, Utah.

Buprenorphine is a medication approved by the FDA to treat Opioid Use Disorder (OUD). Castleview Hospital currently does not prescribe buprenorphine in the emergency department (ED) instead it refers patients to outside addiction treatment facilities. This is a service focused project which the University of Utah will provide mentoring and education to Castleview in implementing an in ED buprenorphine/naloxone distribution program along with referral to continued services. After the program has been implemented, the investigators will evaluate it using quantitative surveys of program participants and qualitative interviews of hospital staff and stakeholders.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Among health care environments, ED often are the front lines of care for those with OUD or who experience opioid overdose.

The University of Utah Hospital ED has the Bridge Program which provides buprenorphine and naloxone with warm-hand off referral for continued treatment to people presenting with OUD. In order to extend the services offered by the Bridge Program to rural hospitals, the investigators will be providing mentoring and education to Castleview Hospital in establishing a similar program. Castleview Hospital is the only acute care hospital that serves Carbon and Emery counties, which outside of the Salt Lake City metro area have the highest opioid overdose rates in the State of Utah.

This project will utilize both quantitative and qualitative measures to evaluate the impact of this program on patients, hospital staff, and community members.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quantitative Interviews

Any Castleview patient who participates in this model will be emailed both the Patient Satisfaction Questionnaire Short Form (PSQ 18) and the Government Performance and Results Act surveys after hospital discharge, six months, and at discharge for buprenorphine.

Implementation of the BINDeR-Tx service model

Intervention Type BEHAVIORAL

ED-initiated buprenorphine, discharge with naloxone, and warm-hand off referral for continued treatment for individuals with OUD. This is considered standard treatment at the University of Utah ED. In order to extend these services to rural hospitals this study will be assisting Castleview Hospital to establish a similar program.

Qualitative Interviews

Qualitative interviews among providers, stakeholders and community members associated with Castleview Hospital will be conducted after the model has been deployed. The qualitative interviews will come from The Consolidated Framework for Implementation Research (CFIR) which is a validated tool that was developed that was developed to evaluate implementation studies.

Implementation of the BINDeR-Tx service model

Intervention Type BEHAVIORAL

ED-initiated buprenorphine, discharge with naloxone, and warm-hand off referral for continued treatment for individuals with OUD. This is considered standard treatment at the University of Utah ED. In order to extend these services to rural hospitals this study will be assisting Castleview Hospital to establish a similar program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implementation of the BINDeR-Tx service model

ED-initiated buprenorphine, discharge with naloxone, and warm-hand off referral for continued treatment for individuals with OUD. This is considered standard treatment at the University of Utah ED. In order to extend these services to rural hospitals this study will be assisting Castleview Hospital to establish a similar program.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

For qualitative interviews with providers, administrators, stakeholders:

* Must be affiliated with Castleview Hospital as a provider, administrator or stakeholder.

For the quantitative surveys:

* Must be a Castleview Hospital patient who receives the BINDeR-Tx model.

Exclusion Criteria

For qualitative interviews with providers, administrators, stakeholders:

* Not familiar with the BINDeR-Tx model
* No interaction with the BINDeR-Tx model

For the quantitative surveys:

* Unable to speak and read English
* Subject is unable to provide contact information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jerry Cochran

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jerry Cochran

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jerry Cochran

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Seliski N, Madsen T, Eley S, Colosimo J, Engar T, Gordon A, Barnett C, Humiston G, Morsillo T, Stolebarger L, Smid MC, Cochran G. Implementation of a rural emergency department-initiated buprenorphine program in the mountain west: a study protocol. Addict Sci Clin Pract. 2024 Sep 3;19(1):63. doi: 10.1186/s13722-024-00496-0.

Reference Type DERIVED
PMID: 39228007 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

158724

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Bundled Intervention
NCT06593093 RECRUITING PHASE1/PHASE2
Mobile Peer Support for OUD Recovery
NCT05405712 ACTIVE_NOT_RECRUITING NA
Houston Emergency Opioid Engagement System
NCT03396276 ENROLLING_BY_INVITATION PHASE4