MedTrace Logo

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

NCT03604159 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-01-11

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • New York City Health and Hospitals Corporation

    collaborator OTHER

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Joshua D Lee, MD, MSc · NYU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2020-05-04
Completion
2020-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604159 on ClinicalTrials.gov