Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews

April 4, 2024 updated by: Justin Berk, Lifespan
This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Recruiting
        • Rhode Island Department of Corrections
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Incarcerated individuals include participants in the RIDOC MOUD program.

Organizational stakeholders inlcude clinicians, Wardens, leadership and/or other staff involved in the MOUD program.

Description

Incarcerated individuals, inclusion criteria:

  • English speaking
  • Over the age of 18
  • Diagnosed with opioid use disorder

Incarcerated individuals, Exclusion Criteria:

- Diagnosed with "Severe, Persistent, Mental Illness (SPMI)" Rationale for Exclusion: These individuals suffer from severe mental health disease and therefore warrant greater protection, have greater risk for coercion, and offer insights to severe co-diagnosis treatment that, while important, remain outside the scope of general MAT implementation.

Organizational Stakeholders, Inclusion Criteria:

- Employed or contracted by Rhode Island Department of Corrections (for organizational staff interviews) and involved with the Medication for Addiction Treatment (MAT) program

Organizational Stakeholders, Exclusion Criteria:

- If not permitted by their organizational union to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Incarcerated Individuals
Incarcerated individuals will be recruited across the Rhode Island Department of Corrections (RIDOC)facility during the required group sessions for treatment; this is consistent with previous NIH-funded studies at RIDOC. The interviews will be described and participants will be able to sign up confidentially. Participants who are eligible for Medications for Opioid Use Disorder (MOUD) but decide not to pursue treatment will still be interviewed to provide better understanding of the key factors that drive program participation. These individuals can be recruited through routine clinical care by addiction medicine providers. Every precaution will be taken to ensure confidentiality and protection of all participants.
Stakeholders
Organizational stakeholders (clinicians, Wardens, leadership and/or other staff) will be recruited through snowball sampling. I will individually approach leaders of each facility to recruit correctional individuals interested in participating and will also allow participants to confidentially sign up at administrative meetings related to Medication for Addiction Treatment (MAT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Transcripts
Time Frame: 1 year
A directed content analysis will identify key themes in structured interviews
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifespan

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Justin Berk, MD, Lifespan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB1967355
  • K23DA055695 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Given the sensitivity of data, some individual data may be censored but will be available to other researchers in aggregate.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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