"Bupe by the Book": A Tele-Buprenorphine Clinical Trial in Public Libraries With Unstably Housed Persons With Opioid Use Disorder

Control Group Clinical Trial

— BBB  

Official title:

"Bupe by the Book": Developing and Testing a Tele-Buprenorphine Intervention in Public Libraries With Unstably Housed Persons With Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872386
• Other study ID #: BBB
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Public libraries nationwide are facing an on-premise opioid overdose crisis. Many persons with opioid use disorder (OUD) remained unhoused and profoundly hard to reach. This study innovatively develops and tests a telemedicine intervention delivered through public libraries to increase unstably housed individuals' access to bupe treatment that would prevent overdoses from occurring in the first place. The investigators will conduct a 12-week pilot 2-arm randomized controlled trial (RCT) (n=40). Research staff will recruit library patrons and randomize them to weekly telehealth at the library or in-person clinic control arms across two participating libraries in San Diego.

Description:

Libraries have become places of refuge for unstably housed individuals with OUD. "Two overdoses a day" occurred just outside the library, according to focus group participants in the investigator's 2019 study on Homelessness in Public Spaces: An Assessment at the San Diego Central Library. Libraries have already taken extraordinary measures to help unstably housed patrons with OUD. The San Diego Central Library trained security staff to carry Narcan to save patrons who overdose in their bathrooms. To deal with daily patron mental health crises, libraries now have social workers, nurses, and peer homeless outreach staff on-site. Buprenorphine "bupe" is a highly effective medical treatment for OUD. However, the investigator's preliminary work shows that unstably housed persons with OUD at libraries perceive lack of bupe access due to transportation and medical coverage issues as barriers to treatment.

"Bupe by the Book" (BBB), in collaboration with the investigators' established local partners, San Diego Public Libraries and Father Joe's Village Health Center (FJV), will innovatively adapt FJV's already successful same-day, free tele-bupe treatment to library settings where OUD patrons are already. BBB will be a groundbreaking 12-week intervention that leverages the library's resources to facilitate low-barrier tele-bupe care via local clinic providers without requiring access to a clinic. By testing BBB uptake and retention in libraries, this study will inform how unstably housed persons and others can receive bupe care in innovative ways with minimal clinical/non-clinical requirements (e.g., low-barrier induction), changing the landscape radically for implementing bupe.

Using a mixed methods approach, the study combines qualitative and quantitative methodologies to address three specific aims:

1. Develop "Bupe by the Book" (BBB) within TAM: Through formative research using intervention mapping, the investigators will conduct a series of 8 focus groups across 4 libraries to: a) assess perceptions of key stakeholders such as local residents, businesses, library staff/security, outreach workers, tele-bupe providers, and unstably housed persons with OUD about BBB's potential, b) develop a feasible plan with stakeholder input, and c) identify facilitators and modifiable barriers to implementation.

2. Determine the feasibility of BBB: Estimate the expected level of treatment uptake and adherence. The investigators will conduct a 12-week pilot 2-arm randomized controlled trial (RCT) (n=40). Research staff will recruit library patrons and randomize them to weekly telehealth at the library or in-person clinic control arms across two participating libraries in San Diego. A health provider at FJV will then screen participants in person for eligibility for same-day bupe induction. BBB's effects on bupe induction and adherence to prescribed doses will be based on self-reported measures at 1-,2-,4-,8-, 12- weeks follow-ups with study staff, and weekly drug screenings and prescription pickups. The study hypothesizes that the BBB vs. control group, will have higher uptake and longer adherence to treatment.

3. Evaluate the acceptability of BBB: Identify program components that could be improved to enhance adherence and patient satisfaction. Research staff will conduct structured interviews with BBB patients, health providers, and library staff to gain insight into the patients' experiences after receiving BBB.

In line with NIDA's 2020 Strategic Plan (Objective 3.4. Develop and test strategies for effectively and sustainably implementing evidence-based treatments), the proposed study addresses long-standing barriers to bupe uptake/adherence. By utilizing multiple library sites, the investigators will render tele-bupe reproducible for other libraries nationwide facing opioid overdoses. This work will pave the foundation for a larger RCT in a subsequent R01 to evaluate the efficacy of utilizing public settings to treat substance use disorders and reduce opioid-related deaths.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All participants interested in OUD treatment will be eligible for study screening regardless of OUD and treatment history. However, they cannot already be on bupe with an active medical prescriber unless they can no longer stay with that provider. We will accommodate participants with disabilities. The FJV medical provider will determine if bupe is appropriate for the individual and able to proceed in BBB.

Exclusion Criteria:

• Persons with comorbidities or polysubstance use that needs a different level or type of care from bupe will not be enrolled in either study arm. Participants ineligible for FJV or the libraries will be ineligible for this study.

Related Conditions & MeSH terms

• Control Group
• Opioid-Related Disorders

Intervention

Behavioral:
• Buprenorphine uptake/retention via Telehealth
Bupe by the Book (BBB) randomly assigns unstably housed library patrons with opioid use disorder to a telehealth to receive buprenorphine (aka, Suboxone) treatment from Father Joe's Villages Health Center.
• Control group
unstably housed library patrons with opioid disorder are assigned randomly to a treatment as usual control group (in-person at the clinic)

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	buprenorphine uptake	participants will pick up prescriptions and take them	within first 2 weeks
Primary	buprenorphine adherence	participants will adhere to prescription by taking buprenorphine for at least 8 weeks	8-12 weeks
Secondary	adherence to appointments	adherence to appointments	1-12 weeks
Secondary	telebupe feasibility	adherence to telehealth	12 weeks
Secondary	Opioid use/overdose and other substance use	weekly oral cheek swab drug screenings and fentanyl self-tests and self-report from surveys	1,2,4,8,and 12 weeks