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

NCT05872386 | Active Not Recruiting DMC

• 1 other identifier: BBB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Telehealth at the Library; Control Group

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• adherence to appointments

  1-12 weeks

• telebupe feasibility

  1-12 weeks

• Opioid use/overdose and other substance use

  1,2,4,8,and 12 weeks

Study Arms (2)

Telehealth

EXPERIMENTAL

Intervention arm

Behavioral: Buprenorphine uptake/retention via Telehealth

Treatment as Usual

EXPERIMENTAL

Treatment as usual (in-person at clinic)

Behavioral: Control group

Interventions

Buprenorphine uptake/retention via Telehealth BEHAVIORAL

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.

Telehealth

Control group BEHAVIORAL

unstably housed library patrons with opioid disorder are assigned randomly to a treatment as usual control group (in-person at the clinic)

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• San Diego State University: collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (2)

• Urada LA, Marienfeld C, Partch M, Garfein RS, Strathdee SA, Nicholls MJ, Weitensteiner A, Zuniga ML, Davidson P, Pitpitan EV. "Bupe by the book": A study protocol for a pilot randomized controlled trial of library-facilitated telehealth to increase buprenorphine treatment among individuals experiencing homelessness. Addict Sci Clin Pract. 2025 Sep 17;20(1):74. doi: 10.1186/s13722-025-00599-2.

  PMID: 40958110 DERIVED

• Urada LA, Marienfeld C, Partch M, Garfein RS, Strathdee SA, Nicholls MJ, Weitensteiner A, Zuniga ML, Davidson P, Pitpitan E. "Bupe by the Book": A study protocol for a pilot randomized controlled trial of library-facilitated telehealth to increase buprenorphine treatment among unstably housed individuals. Res Sq [Preprint]. 2024 Nov 25:rs.3.rs-5507141. doi: 10.21203/rs.3.rs-5507141/v1.

  PMID: 39649172 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will conduct a 12-week pilot 2-arm randomized controlled trial (RCT) (n=40-60). 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 Record Dates

• First Submitted: May 14, 2023
• First Posted: May 24, 2023
• Study Start: June 28, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: During the study (until June 2024) and after until study closure (approx. 5 years).
• Access Criteria: Researchers or data specialists at FJVHC partnering with the BBB researchers.

Locations

US (1)