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

• Status: Completed
• Trial end date: 2020-05-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: NYC Health + Hospitals
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

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.