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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Control Group; Telehealth at the Library
• Intervention / Treatment: Behavioral: Buprenorphine uptake/retention via Telehealth; Behavioral: Control group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • San Diego State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth; Intervention arm	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.
Experimental: Treatment as Usual; Treatment as usual (in-person at clinic)	Behavioral: Control group; unstably housed library patrons with opioid disorder are assigned randomly to a treatment as usual control group (in-person at the clinic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
buprenorphine uptake	participants will pick up prescriptions and take them	within first 2 weeks
buprenorphine adherence	participants will adhere to prescription by taking buprenorphine for > 1 times and ideally for at least 8 weeks	8-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to appointments	adherence to appointments	1-12 weeks
telebupe feasibility	adherence to telehealth	1-12 weeks
Opioid use/overdose and other substance use	weekly biomarkers (urinary or oral drug and fentanyl screenings/self-tests) and self-report from surveys	1,2,4,8,and 12 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: BBB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan is to share individual-level data with the internal research team, including partners at Father Joe's Villages Health Center (FQHC) to obtain their data.
• IPD Sharing Time Frame: During the study (until June 2024) and after until study closure (approx. 5 years).
• IPD Sharing Access Criteria: Researchers or data specialists at FJVHC partnering with the BBB researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No