Status:

NOT_YET_RECRUITING

Injectable Buprenorphine in Prison: a Preference Trial

Lead Sponsor:

Lifespan

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Opioid Use Disorder

Incarceration

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 pri...

Detailed Description

This study is a pilot hybrid effectiveness-implementation trial using a partially randomized preference trial (PRPT) design to evaluate two formulations of extended-release buprenorphine (XR-B)-Subloc...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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
  • 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.

Key Trial Info

Start Date :

June 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06880718

Start Date

June 1 2025

End Date

June 1 2027

Last Update

March 20 2025

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