Opioid AbuseBINDeR-TXNCT06087991
Buprenorphine Induction and Naloxone Distribution Program-Combined With Warm Hand-Off Referral to Continued Treatment
An observational study of Opioid Abuse, run by Jerry Cochran at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse
- What is being tested?
- Implementation of the BINDeR-Tx service model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 qualitative interviews of Castleview providers and stakeholders; 337 Castleview patient participants given buprenorphine and naloxone kits
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Opioid Abuse
- Being tested
- Implementation of the BINDeR-Tx service model
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the BINDeR-Tx service modelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Implementation of the BINDeR-Tx service model | |
| 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. Receives: Behavioral: Implementation of the BINDeR-Tx service model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Focused: Number of patients receiving services.
Will be the aggregate number of individuals who received ED-initiated buprenorphine.
Measured: 24 months
Secondary outcomes (10)
Implementation and service quality: Satisfaction with projected service
Qualitative interviews including clinicians, hospital staff, and community members associated with Castleview Hospital will be the investigators using the Consolidated Framework for Implementation Research (CFIR).
Measured: 24 months.
Implementation and service quality: Patient satisfaction
Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Measured: enrollment and 6 months post enrollment
Substance use diagnosis and treatment
Using the Government Performance and Results Act (GPRA) Outcome questions on substance use within the past 30 days, other substance use disorder diagnoses and treatment in the past 30 days, and mental health diagnoses.
Measured: enrollment and 6 months post enrollment
Social Connectedness
Social connectedness will be measured using the GPRA questions on mutual support group attendance in the last 30 days and relationship satisfaction and support.
Measured: enrollment and 6 months post enrollment
Living Conditions
Living conditions will be measured using the GPRA questions on residence within the past 30 days.
Measured: enrollment and 6 months post enrollment
Mental and Physical Health Problems and Treatment/Recovery
Mental and physical health problems and treatment/recovery will be measured using the GPRA questions on mental health symptoms and medical care received in the past 30 days and insurance status.
Measured: enrollment and 6 months post enrollment
Legal Status
Legal status will be measured using the GPRA questions on incarceration in the past 30 days, charges, trial, sentencing, parole, probation, and drug court status.
Measured: enrollment and 6 months post enrollment
Discharge status
Discharge status will be measured using the GRPA questions on substance use diagnosis and treatment in the past 30 days.
Measured: enrollment and 6 months post enrollment
Follow-up Status
Follow-up status will be measured using the GPRA questions on contact and follow-up status.
Measured: enrollment and 6 months post enrollment
Education, Employment, and Income
Education, employment, and income will be measured using the GPRA questions on education level, employment status, living expenses and income status.
Measured: enrollment and 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerry Cochran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jerry Cochran, University of Utah
- Investigators
- Jerry Cochran, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087991
- Sponsor's protocol ID
- 158724
- Acronym
- BINDeR-TX
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39228007
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Induction and Naloxone Distribution Program-Combined With Warm Hand-Off Referral to Continued Treatment
- ClinicalTrials.gov ID
- NCT06087991
- Acronym / sponsor ID
- BINDeR-TX / 158724
- Conditions
- Opioid Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Jerry CochranUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantitative Interviews | – | Behavioral: Implementation of the BINDeR-Tx service modelAny 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. |
| Qualitative Interviews | – | Behavioral: Implementation of the BINDeR-Tx service modelQualitative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 qualitative interviews of Castleview providers and stakeholders; 337 Castleview patient participants given buprenorphine and naloxone kits
Key inclusion criteria (4 listed)
- Must be affiliated with Castleview Hospital as a provider, administrator or stakeholder.
- Must be a Castleview Hospital patient who receives the BINDeR-Tx model.
Key exclusion criteria (6 listed)
- Not familiar with the BINDeR-Tx model
- No interaction with the BINDeR-Tx model
- Unable to speak and read English
- Subject is unable to provide contact information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of the BINDeR-Tx service modelED-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. | Behavioural | Qualitative Interviews, Quantitative Interviews |
Primary outcome
Patient Focused: Number of patients receiving services.
Time frame: 24 months
Will be the aggregate number of individuals who received ED-initiated buprenorphine.
10 secondary outcomes
Implementation and service quality: Satisfaction with projected service
Time frame: 24 months.
Implementation and service quality: Patient satisfaction
Time frame: enrollment and 6 months post enrollment
Substance use diagnosis and treatment
Time frame: enrollment and 6 months post enrollment
Social Connectedness
Time frame: enrollment and 6 months post enrollment
Living Conditions
Time frame: enrollment and 6 months post enrollment
Mental and Physical Health Problems and Treatment/Recovery
Time frame: enrollment and 6 months post enrollment
Legal Status
Time frame: enrollment and 6 months post enrollment
Discharge status
Time frame: enrollment and 6 months post enrollment
Follow-up Status
Time frame: enrollment and 6 months post enrollment
Education, Employment, and Income
Time frame: enrollment and 6 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Derived from this study: PubMed 39228007Seliski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Cochran principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Abuse, run by Jerry Cochran at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Focused: Number of patients receiving services. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.