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Community Studies of Long Acting Buprenorphine (CoLAB)

NCT03809143 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-05

No results posted yet for this study

Summary

Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in real-world settings has been limited by shorter retention than for methadone, and the need for daily or near-daily dosing (frequently supervised in Australia). Newly developed sustained-release BPN formulations could provide rapid onset and sustained release of BPN.

Current formulations include six-monthly implants, and once-weekly or once-monthly injections, removing the need for frequent clinic or pharmacy attendance. Improved medication adherence may result in improved patient outcomes and fewer unintended consequences such as diversion, but more data are needed in real-world settings. These innovations have the potential to dramatically change the treatment settings and options for people who are opioid dependent.

The study aims to evaluate the patient outcomes following the implementation of a monthly BPN depot injection for the treatment of opioid dependence in community-based treatment settings with a focus on opioid and other illicit drug use, adherence and retention, and participants' experiences of the implementation.

Conditions

  • Opioid Dependence

Interventions

DRUG

RBP-6000

All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.

Sponsors & Collaborators

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Michael Farrell · National Drug and Alcohol Centre, University of New South Wales

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2020-11-01
Completion
2021-03-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

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 NCT03809143 on ClinicalTrials.gov