A randomised double blind placebo controlled clinical trial of naltrexone implants for the treatment of heroin addiction [ 2004 - 2006 ]

Research Grant

Researchers: Prof Gary Hulse (Principal investigator) ,  A/Pr Diane Arnold-Reed ,  Prof Max Bulsara

Brief description GoMedical Industries has developed a formulation of sustained release naltrexone, suitable for subcutaneous depot administration (International Patent Application Number: PCT-AU01-01107, GoMedical Industries Pty Ltd, Australia). Currently, implants are inserted by minor surgery under local anaesthetic in high risk patients under the Therapeutic Goods Administration (TGA) Special Access Category A scheme (SAS) through the Australian Medical Procedures Research Foundation (AMPRF), Western Australia. Although there is a preliminary basis for believing that this naltrexone implant treatment may offer significant benefits over oral and other naltrexone depot preparations thus far reported for managing the heroin dependent patient, this needs to be verified through an empirically designed study such a clinical trial. Lack of complete Commonwealth TGA approval to date has been a major impediment to widespread adoption of this naltrexone preparation as an alternative treatment. Hence, the main objective of this study is to provide rigorous clinical data on the efficacy of this naltrexone implant compared to oral naltrexone in the management of heroin dependent persons by primarily monitoring: Maintenance of blood naltrexone and 6-b-naltrexol concentrations above therapeutic levels Retention in treatment assessed by detection of blood naltrexone or 6-b-naltrexol Reduced frequency and quantity of opiate use Prevention of accidental opiate overdose Reduced opiate related morbidity and mortality Reduced craving for heroin and secondarily monitoring: Frequency and quantity of other drug use Other drug related accidental overdose, other morbidity or mortality Level of social functioning . General health Monitoring of implant insertion site healing

Funding Amount $AUD 558,675.00

Funding Scheme NHMRC Project Grants

Notes Standard Project Grant