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

Last updated: December 13, 2021
Sponsor: NYU Langone Health
Overall Status: Completed

Phase

4

Condition

Opioid Use Disorder

Treatment

N/A

Clinical Study ID

NCT03604159
18-00823
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 opioidtreatment program.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 52
Study Start date:
June 24, 2019
Estimated Completion Date:
May 04, 2020

Connect with a study center

  • Bellevue Hospital Center

    New York, New York 10016
    United States

    Site Not Available

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