Recruiting

XR-B

Sponsor:

Lifespan

Code:

NCT06354465

Conditions

Opioid Use Disorder

Criminal Justice

Treatment Adherence and Compliance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 ID

NCT06354465

Start date

Jul 1, 2023

Status verified date

Apr, 2024

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • Qualitative Transcripts [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Justin Berk, MD

8064333960justin_berk@brown.edu

Locations

Rhode Island Department of Corrections

Recruiting

Cranston, Rhode Island, United States, 02920

Contacts

Jessica Migliaccio

401-462-3921doc.planning@doc.ri.gov

More Information

Sponsor

Lifespan

Last update posted

Apr 9, 2024

Last verified

Apr, 2024

Keywords

  • addiction
  • criminal justice
  • Medications for opioid use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lifespan on 2024-04-09.