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

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine Extended Release
Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring Opioid dependence, Buprenorphine, primary care treatment, extended-release buprenorphine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bellevue Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buprenorphine Extended-Release

Sublingual Buprenorphine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The # of Participants That Received Their Randomly Assigned Study Medication
Received assigned study medication
The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
Received assigned study medication prior to release as scheduled

Full Information

First Posted
July 5, 2018
Last Updated
December 13, 2021
Sponsor
NYU Langone Health
Collaborators
NYC Health + Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03604159
Brief Title
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Official Title
Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
NYC Health + Hospitals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
Opioid dependence, Buprenorphine, primary care treatment, extended-release buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine Extended-Release
Arm Type
Experimental
Arm Description
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.
Arm Title
Sublingual Buprenorphine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Extended Release
Other Intervention Name(s)
SUBLOCADE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Intervention Description
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.
Primary Outcome Measure Information:
Title
# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8
Description
Retained on any form of community buprenorphine treatment at Week 8
Time Frame
8 Weeks
Title
# of Participants Retained on Their Randomly Assigned Treatment at Week 8
Description
Retained on assigned treatment at Week 8
Time Frame
8 weeks
Title
Mean # of Weeks (0-8) on Any Buprenorphine Treatment
Description
Weeks (0-8) on buprenorphine treatment, mean (SD)
Time Frame
8 weeks
Title
Urine Samples Opioid-negative
Description
number of opioid-negative urine samples
Time Frame
8 weeks
Title
the # of Participants Re-incarcerated
Description
Re-incarceration
Time Frame
8 weeks
Title
The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
Description
Jail medical clinic visits per day following study medication induciton, mean
Time Frame
Post-randomization and pre-release, (0-3 months)
Secondary Outcome Measure Information:
Title
The # of Participants That Received Their Randomly Assigned Study Medication
Description
Received assigned study medication
Time Frame
8 Weeks
Title
The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
Description
Received assigned study medication prior to release as scheduled
Time Frame
0-3 months (pre-release)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua D Lee, MD, MSc
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35093164
Citation
Cheng A, Badolato R, Segoshi A, McDonald R, Malone M, Vasudevan K, Badiei B, Sugarman A, Macdonald R, Mangat J, Giftos J, Lee JD, Tofighi B. Perceptions and experiences toward extended-release buprenorphine among persons leaving jail with opioid use disorders before and during COVID-19: an in-depth qualitative study. Addict Sci Clin Pract. 2022 Jan 29;17(1):4. doi: 10.1186/s13722-022-00288-4.
Results Reference
derived
PubMed Identifier
34495340
Citation
Lee JD, Malone M, McDonald R, Cheng A, Vasudevan K, Tofighi B, Garment A, Porter B, Goldfeld KS, Matteo M, Mangat J, Katyal M, Giftos J, MacDonald R. Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail. JAMA Netw Open. 2021 Sep 1;4(9):e2123032. doi: 10.1001/jamanetworkopen.2021.23032.
Results Reference
derived

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

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