NCT03604159

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-24
• Primary completion: 2020-05-04
• Completion: 2020-05-04
• First posted: 2018-07-27
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study