Telehealth at the LibraryBBBNCT05872386
"Bupe by the Book": Testing Library Telehealth With Unstably Housed Persons With Opioid Use Disorder
A study testing Library Telehealth with Buprenorphine Provider in people with Telehealth at the Library and Control Group, run by University of California, San Diego at 1 site in United States.
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'… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telehealth at the Library, Control Group
- What is being tested?
- Library Telehealth with Buprenorphine Provider
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to 30 Nov 2024
- Phase
- Interventional
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
Who may be able to join
- All participants interested in opioid use disorder (OUD) treatment will be eligible for study screening regardless of OUD and treatment history. However, they cannot already be on buprenorphine with a different 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 buprenorphine is appropriate for the individual and able to proceed in the Bupe by the Book trial.
Who cannot join
- Persons with comorbidities or polysubstance use that needs a different level or type of care from buprenorphine will not be enrolled in either study arm. Participants ineligible for FJV Health Center or the public libraries will be ineligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: "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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Telehealth at the Library, Control Group
- Being tested
- Library Telehealth with Buprenorphine Provider, Treatment-as-Usual Control group
- Keywords
- Library, telehealth, opioid use, homelessness, randomized controlled trial, pilot study, buprenorphine, substance use treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Library Telehealth with Buprenorphine ProviderBehavioural
Bupe by the Book (BBB) randomly assigns unstably housed library patrons with opioid use disorder to a library telehealth arm to receive buprenorphine (aka, Suboxone) treatment from Father Joe's Villages Health Center.
Treatment-as-Usual Control groupBehavioural
Unstably housed library patrons with opioid disorder are assigned randomly to a treatment-as-usual control group (in-person at the clinic)
| Study group | Role | What they receive |
|---|---|---|
| Library Telehealth | Experimental | Intervention arm Receives: Behavioral: Library Telehealth with Buprenorphine Provider |
| Treatment as Usual | Active comparator | Treatment as usual (in-person at clinic) Receives: Behavioral: Treatment-as-Usual Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Prescribed and Successfully Administered Buprenorphine
Participants picked up prescriptions, as confirmed by a prescription drug monitoring program database. Participants self-administered buprenorphine as measured by urinary assessments at the public library with results checked by the research staff.
Measured: within first 2 weeks
Buprenorphine Adherence
Participants adhered to prescription by taking buprenorphine for > 1 times and ideally for at least 8 weeks
Measured: 8-12 weeks
Secondary outcomes (3)
Adherence to Appointments
Adherence to medical appointments for buprenorphine were recorded in the medical record data at the health center. Adherence is attending 2+ appointments.
Measured: 2-12 weeks
Library Telehealth Feasibility
Number of patrons who tried library telehealth, whether they were assigned to the library telehealth arm or not, were recorded. Some remained attending the medical visits in-person only or had both telehealth and in-person visits.
Measured: 1-12 weeks
Cessation of Opioid Use (Including Fentanyl) and/or Other Substances
weekly biomarkers (urinary or oral drug and fentanyl screenings/self-tests)
Measured: 1-12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start28 Jun 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Telehealth at the LibraryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Lianne Urada, San Diego State University
- Investigators
- Lianne A Urada, PhD, Principal investigator, San Diego State University and University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872386
- Sponsor's protocol ID
- BBB
- Acronym
- BBB
- Status last verified
- May 2026
- First submitted
- 14 May 2023
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40958110Urada 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.
PubMed 39649172