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Completed

NCT Number: NCT03604159

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

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.

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bellevue Hospital Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buprenorphine Extended Release

Drug

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

Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)

Drug

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 outcomes

  1. # 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

  2. # of Participants Retained on Their Randomly Assigned Treatment at Week 8

    Time frame: 8 weeks

    Retained on assigned treatment at Week 8

  3. Mean # of Weeks (0-8) on Any Buprenorphine Treatment

    Time frame: 8 weeks

    Weeks (0-8) on buprenorphine treatment, mean (SD)

  4. Urine Samples Opioid-negative

    Time frame: 8 weeks

    number of opioid-negative urine samples

  5. the # of Participants Re-incarcerated

    Time frame: 8 weeks

    Re-incarceration

  6. 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 outcomes

  1. The # of Participants That Received Their Randomly Assigned Study Medication

    Time frame: 8 Weeks

    Received assigned study medication

  2. 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • New York City Health and Hospitals Corporation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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