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NCT06354465 Clinical Trial

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

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06354465
Other study ID # IRB1967355
Secondary ID K23DA055695
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2024

Study information
Verified date April 2024
Source Lifespan
Contact Justin Berk, MD
Phone 8064333960
Email justin_berk@brown.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Rhode Island Department of Corrections Cranston Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Lifespan National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative Transcripts A directed content analysis will identify key themes in structured interviews 1 year
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