CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Buprenorphine Extended Release +1 moredrug
Likely dose
Buprenorphine Extended Release 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03604159
NCT03604159Phase 4Completed
CompareCT.gov

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

NYU Langone Health·interventional·Posted Jul 27, 2018·Updated Jan 11, 2022

In Brief

A Phase 4 clinical trial evaluating Buprenorphine Extended Release and Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) for Opioid Dependence. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence
CountriesUnited States
CollaboratorsNew York City Health and Hospitals Corporation

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartJun 24, 2019
Primary CompletionMay 4, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.9 years ago

Interventions

Buprenorphine Extended Releasedrug

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.

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.