A Randomised Double Blind Placebo Controlled Clinical Trial Of Naltrexone Implants For The Treatment Of Heroin Addiction
Funder
National Health and Medical Research Council
Funding Amount
$558,675.00
Summary
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 Australi ....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 healingRead moreRead less
Effect Of Naltrexone Treatment On Mental Health And Other Health Outcomes : A Record Linkage Study.
Funder
National Health and Medical Research Council
Funding Amount
$111,625.00
Summary
Research has shown that heroin use is an increasing habit of Australia's youth with morbidity and mortality rates for regular heroin users significantly greater than that for the general population. Despite the introduction of a number of treatment options to combat the problem, the management of dependent heroin use has proved problematic. This application addresses an issue of considerable importance and controversy in recent years, namely, the impact of naltrexone and methadone treatment on m ....Research has shown that heroin use is an increasing habit of Australia's youth with morbidity and mortality rates for regular heroin users significantly greater than that for the general population. Despite the introduction of a number of treatment options to combat the problem, the management of dependent heroin use has proved problematic. This application addresses an issue of considerable importance and controversy in recent years, namely, the impact of naltrexone and methadone treatment on morbidity and mortality among persons who are heroin dependent. The study will be carried out using a unique system of linked hospital records from the Western Australian Health Services Research Linkage Unit at the Department of Health Western Australia (DHWA). Through this system hospital, mental health and death records derived from different sources, but related to the same individual are electronically linked. Hence, record linkage provides an independent method for obtaining information on treatment outcomes which is free from subjective bias. In the current study records from heroin users who entered naltrexone maintenance and a smaller group who entered methadone maintenance will be linked to the DHWA database. Collectively these data will be used to quantify morbidity, hospital episodes, mental health issues and mortality in heroin users following commencement of naltrexone maintenance treatment. Data will also be used to compare positive and negative outcomes for individuals on naltrexone with those on methadone. The results will be used to advocate on behalf of this vulnerable population in a country that prides itself on universal access to high quality health services. It is anticipated that this study will have a substantial beneficial impact on the management of illicit drug use policy and as well as contributing new research methods, findings and international knowledge.Read moreRead less
The Role Of Pharmacotherapy In Prevention Of Relapse In Alcohol Dependence
Funder
National Health and Medical Research Council
Funding Amount
$422,310.00
Summary
The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000-6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Young men are particularly affected, with 10% of all men aged 18-35 dependent on alcohol. Better treatment for alcohol dependence is urgently needed. Less ....The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000-6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Young men are particularly affected, with 10% of all men aged 18-35 dependent on alcohol. Better treatment for alcohol dependence is urgently needed. Less severe forms of alcohol abuse frequently respond to brief screening and intervention programs. Treatment of alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1-3, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large carefully performed study. The study will help determine which subjects are likely to benefit from one or other of these agents. Compliance is a major problem with many medications, but is a particular problem with medications for substance abuse. The second aim of this study is to test a novel intervention to increase compliance with medications for alcohol dependent subjects. This intervention comprises 'compliance therapy', which resembles a short training course, a medication alarm, and an assertive reminder program for scheduled medical appointments. The present study will be the first to apply this type of therapy to subjects with alcohol dependence.Read moreRead less
A Trial Of Therapeutic Drug Monitoring In Methadone Maintenance Treatment
Funder
National Health and Medical Research Council
Funding Amount
$542,025.00
Summary
Heroin addiction is an established and increasing problem in developed countries and in many developing nations. Although there have been several new treatments for heroin addiction, methadone maintenance remains the most effective way to minimize the harms associated with heroin addiction. The current research proposal seeks to test a new approach to setting of methadone dose, using monitoring of methadone blood levels, effects and side-effects in determining when to increase doses, and when to ....Heroin addiction is an established and increasing problem in developed countries and in many developing nations. Although there have been several new treatments for heroin addiction, methadone maintenance remains the most effective way to minimize the harms associated with heroin addiction. The current research proposal seeks to test a new approach to setting of methadone dose, using monitoring of methadone blood levels, effects and side-effects in determining when to increase doses, and when to switch to alternative therapies. This provides an objective method of planning treatment that focuses on suppressing heroin use. The potential subjects of the study are the 50% of patients who continue to use heroin regularly during treatment. All will undergo assessment involving measurement of blood levels of methadone, testing of effects and side-effects of methadone, and monitoring of safety. Half will be randomly allocated to usual care, and half to therapeutic drug monitoring, with dose adjustments according to the results of testing. At 3 and 6 months all subjects will undergo repeat test sessions. It is hypothesized that those in the experimental group will be using less heroin (confirmed by hair testing). It is expected that the study will also identify a small group of subjects with genetically different opioid receptors, who will require very high doses of methadone to be stabilized. The study will allow a detailed analysis of how best to monitor dose adequacy; the relationship between withdrawal symptoms, methadone blood levels, and heroin use, and will provide the first clear investigation of the relationship between changes in methadone blood concentration and certain potentially dangerous changes in the electrical activity of the heart. The intended outcome of this research project is a model for a higher standard methadone program that is more effective in reducing the problems of heroin use in our community.Read moreRead less