drugset / Trial / NCT03809143

Community Studies of Long Acting Buprenorphine (CoLAB)

NCT03809143

Phase 3 Unknown 100 enrolled The University of New South Wales
NaSingle-groupOpen-labelHealth-services research

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.

Timeline

Start
2019-05-22
Primary completion
2020-11-01
Completion
2021-03-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject RBP-6000 Unknown 200 mg/ml Subcutaneous

Indications