Injectable Buprenorphine in Prison: a Preference Trial

NCT06880718 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: IRB 2210402K23DA055695
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community. The main question it aims to answer are: How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment? Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial. Participants will:

• Choose which medication they prefer or be randomly assigned if they don't have a preference.
• Receive monthly injections of either Sublocade or Brixadi before and after release from prison.
• Complete surveys and clinical assessments on treatment experience and acceptability.
• Be monitored for treatment retention, opioid use, and adverse events for six months post-release. Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.

Conditions

Opioid Use Disorder; Incarceration; Medications for Opioid Use Disorder; Buprenorphine

Keywords

opioid use disorder; incarceration; prison; long-acting injectable; buprenorphine; XR-B

Outcome Measures

Primary Outcomes (5)

• Preliminary Effectiveness

  Preliminary Effectiveness will be measured through rates of community treatment continuation post-release. Outpatient treatment engagement over the first three months post-release will be assessed using study records of CPC Recovery Clinic follow-up appointments. For patients that do not follow at the CPC Recovery Clinic, statewide administrative data from the Rhode Island Prescription Drug Monitoring Program (PDMP) database covering community pharmacy fills of buprenorphine products will be used to supplement treatment retention outcomes. PDMP data will also be used to track community treatment continuation for all participants from three to six months post-release. Participants will be logged as continuing buprenorphine treatment at each month if: (1) CPC Recovery Clinic records show that they were present at their scheduled follow-up visit, or (2) the PDMP indicates that they continued treatment elsewhere and have not had a gap of more than 30 days in dispensed medication.

  3 months post-release

• Implementation Outcomes: Acceptability

  Acceptability will be measured through initial patient preference, in-facility treatment retention, and the validated Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) assesses the extent to which an intervention is perceived as satisfactory or agreeable by stakeholders. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater acceptability of the intervention.

  Baseline, Immediately after the intervention

• Implementation Outcomes: Feasibility

  Feasibility will be measured by the validated Feasibility of Intervention Measure (FIM) and enrollment rates. The Feasibility of Intervention Measure (FIM) evaluates the degree to which an intervention can be successfully used or implemented within a given setting. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater feasibility of implementing the intervention.

  Baseline, Immediately after the intervention

• Implementation Outcomes: Appropriateness

  Appropriateness will be measured by the validated Intervention Appropriateness Measure (IAM). The Appropriateness of Intervention Measure (IAM) measures how well an intervention fits with the setting, needs, or problem it is intended to address. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater perceived appropriateness of the intervention.

  Baseline, Immediately after the intervention

• Implementation Outcomes: Fidelity

  Fidelity will be measured by the proportion of doses administered within the 26-35 day range of appropriate dosing cadence.

  Baseline, Immediately after the intervention

Secondary Outcomes (5)

• Client Outcomes: Satisfaction

  During the intervention

• Client Outcomes: Function - Healthcare Utilization

  During the intervention

• Client Outcomes: Function - Recidivism

  During the intervention, 3 months after the intervention

• Client Outcomes: Treatment Satisfaction

  During the intervention

• Client Outcomes: Function - Return to Use

  During the intervention

Study Arms (2)

Sublocade

ACTIVE COMPARATOR

Participants receive Sublocade-branded injectable buprenorphine.

Drug: Sublocade

Brixadi

ACTIVE COMPARATOR

Participants receive Brixadi-branded injectable buprenorphine.

Drug: Brixadi (Injectable Buprenorphine)

Interventions

Brixadi (Injectable Buprenorphine) DRUG

Brixadi comes in several doses and can be administered on a weekly or monthly basis. For clinical reasons (i.e., each patient will already be on a stable dose of MOUD in a setting without significant illicit opioid use), the monthly injection will be used. The approximately equivalent to the 300mg Sublocade dose is 96mg of Brixadi. The maximum dose is 128mg. Brixadi can be administered in the abdomen, buttocks, or triceps. Participants in the Brixadi treatment arm will be given one or more Brixadi injections each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Brixadi is covered by most Medicaid health insurances in the state of Rhode Island.

Also known as: CAM2308, Buvidal

Brixadi

Sublocade DRUG

Sublocade is a 100mg or 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. Participants in the Sublocade treatment arm will be given monthly Sublocade injections, as clinically indicated, each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Sublocade is covered by most Medicaid health insurances in the state of Rhode Island. The standard dosing schedule is two months of 300mg followed by monthly 100mg injections. To maximize real-world generalizability, the medication dosing will be determined by clinical indication of the provider who will have the flexibility to provide medication dosing based on their clinical acumen and/or shared decision-making.

Sublocade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be at least 18 years of age and incarcerated in the RIDOC facility,
• be currently diagnosed with OUD and enrolled in the RIDOC MOUD program,
• have an expected release date within 120 days of study enrollment,
• have an interest in XR-B and
• be English speaking

You may not qualify if:

• individuals who are pregnant or planning conception,
• diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
• have a release date within 21 days of initiation, or

Sponsors & Collaborators

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

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Justin Berk, MD MPH MBA

CONTACT

(401) 680-1074; justin_berk@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL