Recruiting

Sublocade vs. Brixadi

Sponsor:

Lifespan

Code:

NCT06880718

Conditions

Opioid Use Disorder

Incarceration

Medications for Opioid Use Disorder

Buprenorphine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brixadi (Injectable Buprenorphine)

Sublocade

Study Details

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

Study ID

NCT06880718

Start date

Feb 18, 2026

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. individuals who are pregnant or planning conception,
2. diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
3. have a release date within 21 days of initiation, or
4. have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sublocade

Participants receive Sublocade-branded injectable buprenorphine.

active comparator: Brixadi

Participants receive Brixadi-branded injectable buprenorphine.

Interventions

Brixadi (Injectable Buprenorphine)

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.

Sublocade

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.

Primary outcome measure

  • Preliminary Effectiveness [ Time Frame: 3 months post-release ]
  • Implementation Outcomes: Acceptability [ Time Frame: Baseline, Immediately after the intervention ]
  • Implementation Outcomes: Feasibility [ Time Frame: Baseline, Immediately after the intervention ]
  • Implementation Outcomes: Appropriateness [ Time Frame: Baseline, Immediately after the intervention ]
  • Implementation Outcomes: Fidelity [ Time Frame: Baseline, Immediately after the intervention ]

Central Contacts and Locations

Central contacts

Justin Berk, MD MPH MBA

(401) 680-1074justin_berk@brown.edu

Locations

Rhode Island Department of Corrections

Recruiting

Cranston, Rhode Island, United States, 02920

Contacts

Jessica Miggliacio

401-462-6721Jessica.Migliaccio@doc.ri.gov

More Information

Sponsor

Lifespan

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

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

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 2026-05-15.