XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

December 13, 2021 updated by: NYU Langone Health

Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone

This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults >18yo incarcerated in NYC jails with known release dates.
  • DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
  • Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.

Exclusion Criteria:

  • Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.
  • Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant
  • No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Buprenorphine Extended-Release
XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.
Drug: Buprenorphine Extended Release
XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.
Other Names:
  • SUBLOCADE
ACTIVE_COMPARATOR: Sublingual Buprenorphine
SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.
Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8
Time Frame: 8 Weeks
Retained on any form of community buprenorphine treatment at Week 8
8 Weeks
# of Participants Retained on Their Randomly Assigned Treatment at Week 8
Time Frame: 8 weeks
Retained on assigned treatment at Week 8
8 weeks
Mean # of Weeks (0-8) on Any Buprenorphine Treatment
Time Frame: 8 weeks
Weeks (0-8) on buprenorphine treatment, mean (SD)
8 weeks
Urine Samples Opioid-negative
Time Frame: 8 weeks
number of opioid-negative urine samples
8 weeks
the # of Participants Re-incarcerated
Time Frame: 8 weeks
Re-incarceration
8 weeks
The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
Time Frame: Post-randomization and pre-release, (0-3 months)
Jail medical clinic visits per day following study medication induciton, mean
Post-randomization and pre-release, (0-3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The # of Participants That Received Their Randomly Assigned Study Medication
Time Frame: 8 Weeks
Received assigned study medication
8 Weeks
The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
Time Frame: 0-3 months (pre-release)
Received assigned study medication prior to release as scheduled
0-3 months (pre-release)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

NYC Health + Hospitals

Investigators

  • Principal Investigator: Joshua D Lee, MD, MSc, NYU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 24, 2019

Primary Completion (ACTUAL)

May 4, 2020

Study Completion (ACTUAL)

May 4, 2020

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (ACTUAL)

July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-00823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).

IPD Sharing Time Frame

To achieve aims in the approved proposal.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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