XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2020
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedJanuary 11, 2022
December 1, 2021
11 months
July 5, 2018
July 30, 2021
December 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
# 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
8 Weeks
# of Participants Retained on Their Randomly Assigned Treatment at Week 8
Retained on assigned treatment at Week 8
8 weeks
Mean # of Weeks (0-8) on Any Buprenorphine Treatment
Weeks (0-8) on buprenorphine treatment, mean (SD)
8 weeks
Urine Samples Opioid-negative
number of opioid-negative urine samples
8 weeks
the # of Participants Re-incarcerated
Re-incarceration
8 weeks
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
Post-randomization and pre-release, (0-3 months)
Secondary Outcomes (2)
The # of Participants That Received Their Randomly Assigned Study Medication
8 Weeks
The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
0-3 months (pre-release)
Study Arms (2)
Buprenorphine Extended-Release
EXPERIMENTALXRB 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.
Sublingual Buprenorphine
ACTIVE COMPARATORSLB (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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- New York City Health and Hospitals Corporationcollaborator
Study Sites (1)
Bellevue Hospital Center
New York, New York, 10016, United States
Related Publications (2)
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.
PMID: 35093164DERIVEDLee 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.
PMID: 34495340DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joshua Lee
- Organization
- NYU Langone
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua D Lee, MD, MSc
NYU School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2018
First Posted
July 27, 2018
Study Start
June 24, 2019
Primary Completion
May 4, 2020
Study Completion
May 4, 2020
Last Updated
January 11, 2022
Results First Posted
January 11, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- To achieve aims in the approved proposal.
- Access Criteria
- Researchers who provide a methodologically sound proposal.
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).