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

Overview

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.

Full Title of Study: “Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 4, 2020

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • # 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
  • # of Participants Retained on Their Randomly Assigned Treatment at Week 8
    • Time Frame: 8 weeks
    • Retained on assigned treatment at Week 8
  • Mean # of Weeks (0-8) on Any Buprenorphine Treatment
    • Time Frame: 8 weeks
    • Weeks (0-8) on buprenorphine treatment, mean (SD)
  • Urine Samples Opioid-negative
    • Time Frame: 8 weeks
    • number of opioid-negative urine samples
  • the # of Participants Re-incarcerated
    • Time Frame: 8 weeks
    • Re-incarceration
  • 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

Secondary Measures

  • The # of Participants That Received Their Randomly Assigned Study Medication
    • Time Frame: 8 Weeks
    • Received assigned study medication
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • NYC Health + Hospitals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joshua D Lee, MD, MSc, Principal Investigator, NYU School of Medicine

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