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

NCT ID: NCT06354465

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-07-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

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.

• If not permitted by their organizational union to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Lifespan

OTHER

Sponsor Role: lead

Responsible Party

Justin Berk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin Berk, MD

Role: PRINCIPAL_INVESTIGATOR

Lifespan

Locations

Rhode Island Department of Corrections

Cranston, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Justin Berk, MD

Role: CONTACT

justin_berk@brown.edu

8064333960

Facility Contacts

Jessica Migliaccio

Role: primary

doc.planning@doc.ri.gov

401-462-3921

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23DA055695

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB1967355

Identifier Type: -

Identifier Source: org_study_id