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

NCT06354465 | Recruiting

• 2 other identifiers: IRB1967355K23DA055695
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder; Criminal Justice; Treatment Adherence and Compliance

Keywords

addiction; criminal justice; Medications for opioid use disorder

Outcome Measures

Primary Outcomes (1)

• Qualitative Transcripts

  A directed content analysis will identify key themes in structured interviews

  1 year

Study Arms (2)

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).

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \- Employed or contracted by Rhode Island Department of Corrections (for organizational staff interviews) and involved with the Medication for Addiction Treatment (MAT) program
• \- If not permitted by their organizational union to participate

Sponsors & Collaborators

• Lifespan: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rhode Island Department of Corrections

Cranston, Rhode Island, 02920, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Treatment Adherence and Compliance; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• Justin Berk, MD

  Lifespan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Berk, MD

CONTACT

8064333960; justin_berk@brown.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 9, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

US (1)