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Naltrexone |
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Buprenorphine |
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LAAM* |
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SROM** |
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Tincture of opium |
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Methadone |
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Drug court |
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Legal injecting rooms |
Rejected by State Govt. Under considera-tion by South Sydney Council |
Under considera-tion by councils |
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* levo-alpha-acetylmethadol
**slow-release oral morphine
New South Wales
Naltrexone
Two clinical trials of rapid opiate detoxification using naltrexone are underway in New South Wales, one at Westmead Hospital (50 patients) and the other at Sydney Hospital (31 patients). Both trials are in two stages. Westmead Hospital is trialing rapid opiate detoxification both with and without anaesthesia and has recruited participants from among heroin users and methadone patients, while participants at Sydney Hospital are trialing the technique under sedation. Participants in the Sydney Hospital trial have also been recruited from among heroin users and methadone patients.
Preliminary data from stage one of the Sydney Hospital trial have been described as 'encouraging' by the New South Wales Minister for Health(9). Data from stage one of both trials will be compared before the NSW Government proceeds with stage two, a full randomised clinical trial at Westmead Hospital.
Participants in a randomised controlled trial are allocated to treatment with either buprenorphine or methadone. A cost-effectiveness study of each drug will be conducted in addition to comparisons on outcomes for participants including health, social functioning, crime, drug use, and HIV and hepatitis risk behaviour.
Buprenorphine is also the subject of a randomised controlled trial which plans to evaluate the efficacy of the drug as a withdrawal treatment at the conclusion of methadone maintenance.
Drug Court
The New South Wales Government announced recently (10 September 1998) that the State would commence a two year trial of a 'drug court' in 1999 at a cost of $5 million. Several hundred drug courts have been established in the United States since the late 1980s and are regarded there as a successful innovation. Details released to date about the New South Wales version indicate that heroin users who plead guilty will be sentenced by the drug court to 12 months rehabilitation instead of prison and will be expected to undergo regular urine tests and supervision to ensure that their heroin use has ceased. Failure to comply with the conditions of rehabilitation will result in sanctions being imposed by the court, including a prison sentence.
Announcing the initiative, the NSW Premier stated that eligible participants would be drug dependent, facing a prison term, be prepared to admit their guilt and willing to participate in the program. Those eligible to appear before the drug court will be facing charges for offences which include non-violent theft, possession, fraud or forgery, stealing from a person, unarmed robbery providing there is no physical harm involved, or dealing in quantities of drugs below the indictable limit. Offences involving violence or offenders involved in sexual offences will be excluded from the drug court process. Legislation to establish the drug court is expected to be introduced during the current sittings of the State Parliament.(10)
Legal Injecting Rooms
Legal heroin injecting rooms, commonly described as 'shooting galleries' have received considerable attention in New South Wales. The Royal Commission into the New South Wales Police Service (Wood Royal Commission) recommended the consideration of legal injecting premises and invited consideration of amendments to the NSW Drug Misuse and Trafficking Act 1985 to enable the establishment of such premises. The Royal Commission identified several reasons in favour of the establishment of legal injecting premises but also warned that close supervision and strict guidelines would be necessary elements of any such initiative.(11)
A NSW Parliamentary Committee was established to consider this proposal of the Wood Royal Commission but voted six members to four against a trial of legal injecting rooms. The NSW Premier had earlier announced that the Government would proceed with a trial only if it received bi-partisan support. Subsequently, the issue has received consideration from local councils, including the South Sydney Council which is investigating whether it has the power to establish such premises under regulations permitting needle exchanges.(12)
Victoria
Five trials of alternative treatments for heroin dependency are underway or planned in Victoria, all of which are overseen by Turning Point, the Victorian drug and alcohol research centre.
Naltrexone
A trial comprising 208 volunteers, previously heroin dependent and who are post-withdrawal, is to examine the effectiveness of naltrexone in reducing relapse rates and improving the outcomes of treatment in such areas as risk taking behaviour, criminality, health status, social functioning and psychosocial adjustment. The sample group will be divided in half with 104 participants receiving naltrexone treatment and 104 as the control group. Participants in the trial are to be recruited from a variety of post-withdrawal services around Melbourne.
Treatment for heroin dependence using levo-alpha-acetylmethadol (LAAM) is to be evaluated in primary care (general practice) and specialist settings. LAAM is suitable as a substitute for methadone in maintenance treatment for heroin dependency but is prescribed on a three times per week basis rather than methadone's daily dosage. The Victorian trial will introduce clinical guidelines and training programs and examine the cost effectiveness of the drug. The trial will also monitor the groups for whom LAAM is most successful as a treatment option.
The trial will involve specialist doctors and GPs with extensive experience in prescribing methadone who will be trained in the management of heroin dependence using LAAM. Pharmacists who are experienced in dispensing methadone will be trained in dispensing and monitoring procedures for LAAM. Guidelines are to be developed to assist the doctors and pharmacists. Volunteer participants will be recruited from heroin users eligible for the methadone program and patients already in a methadone program. Volunteers who are deemed suitable by their doctor will be randomly selected to receive treatment with LAAM or methadone.
Buprenorphine
Buprenorphine is the subject of two trials in Victoria. The first trial will evaluate buprenorphine in the same way as that outlined above for LAAM (i.e. as a means of withdrawing from heroin). The other trial will assess the efficacy of buprenorphine as a means of withdrawal from methadone. This trial is to be conducted in three stages. Stage one is a survey of methadone clients, their pharmacists and methadone providers. Stage two is a pilot dosing study which aims to determine the best way of transferring patients from methadone to buprenorphine, including appropriate dosages. Stage three is a randomised controlled trial designed to test the efficacy of buprenorphine as a methadone withdrawal agent. Participants who are withdrawing from methadone will be randomly assigned to receive reducing doses of buprenorphine or reducing doses of methadone. The dosages established in stage two will be used for the stage three trial.
Slow-Release Oral Morphine
Slow-release oral morphine is a well-established treatment for pain but more research is required to evaluate it as a treatment for heroin dependence. This trial, which is expected to begin by the end of 1998, will evaluate the safety, efficacy and cost effectiveness of slow-release oral morphine. The project will have three components and will comprise 20 heroin dependent participants and 20 methadone-maintained participants. A 24 hour oral morphine is to be used in the trial and outcomes to be measured include treatment compliance, dose adequacy, tolerance, adverse events and morphine-related side effects.
Related studies
Two further studies are planned involving methadone, LAAM and buprenorphine. One study will assess changes in the thinking capacity (cognition) of patients undergoing treatment with these drugs. The other study will investigate the effects on the driving ability of patients undergoing treatment with the drugs.
The Lord Mayor of Melbourne has indicated that a decision on legal injecting premises for heroin users is expected to be made by council in the near future. The City of Greater Dandenong considered establishing legal injecting rooms in 1997 but after receiving advice that this may contravene the provisions of the Victorian Drug Poisons and Controlled Substances Act 1991, has reportedly suspended any firm decision.(13)
The Lord Mayor of Melbourne has called for the establishment of a drug court in Victoria.
South Australia
A three year trial of rapid opiate detoxification using naltrexone has received funding of $466 000 from the South Australian Government. The trial is to be undertaken by the Drug and Alcohol Services Council in collaboration with the Royal Adelaide Hospital and the University of Adelaide. One hundred patients are to be recruited for the trial which will compare two methods of withdrawal from heroin. Participants will be randomly assigned to two groups. Fifty patients will receive rapid opiate detoxification under anaesthesia, followed by twelve months of monitoring, including daily doses of naltrexone. The other group of fifty patients will receive the standard in-patient detoxification procedure (5-7 days) at Warinilla Clinic, followed by twelve months of monitoring including daily doses of naltrexone.
Participants to be recruited for the trial must be: 18 years and older; current heroin users; dependent on heroin; willing and able to participate in a detoxification procedure followed by a twelve month aftercare program; and willing to accept random allocation to treatment. The aftercare component of the trial will involve four face-to-face interviews at one, three, six and nine months after detoxification. During these interviews, blood tests will be taken, current health status and social functioning will be assessed and the effects of naltrexone monitored.
The trial of LAAM in South Australia aims to compare LAAM maintenance with methadone maintenance among participants who have been stabilised on methadone for at least six months. Participants will have three months on each drug and will be offered a free choice between the two drugs at the conclusion of the trial.
A trial of buprenorphine as an alternative maintenance treatment for heroin dependency is underway in South Australia. This trial is similar to a trial in New South Wales. A further trial of buprenorphine is planned which will evaluate the drug's efficacy as a means of withdrawal from methadone.
South Australia is collaborating with clinicians in Thailand to compare the efficacy of tincture of opium with methadone maintenance in a randomised controlled trial. If judged to have value as a maintenance treatment, its use in Australia will be further examined.
Naltrexone
The Queensland Government has recently announced that it is to commit $250 000 for a trial of naltrexone as a treatment for heroin dependency. The trial will be conducted by the director of drug and alcohol services at Royal Brisbane and Prince Charles hospitals, Professor John Saunders. Trial participants will receive either rapid detoxification under general anaesthetic, or accelerated detoxification using sedation or form part of a control group using methadone.
Naltrexone
The Western Australian Government has allocated $180 000 to two trials involving naltrexone. Dr George O'Neil has conducted an independent study of 750 heroin users since June 1997. A review of his first 100 patients has reportedly revealed that more than 75 per cent were positively managing their addiction after six months of treatment with naltrexone. To date, funding of $60 000 has been provided to Dr O'Neil's project by the state government for data gathering and analysis. The commitment of further funding to this project is currently under consideration. Funding of $20 000 has been allocated to the Department of Psychiatry at the University of Western Australia.
Naltrexone
Naltrexone is the subject of two trials in the ACT, which are examining its efficacy in withdrawal from heroin and withdrawal from methadone. ACT Community Care (ACTCC) has been contracted to undertake a trial of accelerated detoxification from methadone using naltrexone. ACTCC has subcontracted the research and investigation services of the National Centre for Epidemiology and Population Health (NCEPH). The trial is a multicentre study involving the ACTCC Alcohol and Drug Program's Detoxification Unit at Canberra Hospital and the Langton Centre in Sydney.
This trial consists of 15 methadone maintained patients (from the ACTCC Methadone Maintenance Program) who will be inducted onto naltrexone using naltrexone accelerated detoxification. The trial will document the severity of withdrawal, acceptability and rate of successful completion. Subjects will be monitored for three months to review their experience of detoxification and success in maintaining naltrexone maintenance and avoiding relapse to heroin use. A report and recommendations on a future trial will be made to the ACT Department of Community Care.
The National Centre for Epidemiology and Population Health has been contracted to conduct another trial which will examine the use of naltrexone and buprenorphine in the management of heroin withdrawal. NCEPH is to subcontract the ACTCC's Alcohol and Drug Program to provide clinical support for the trial, which will comprise 20 dependent heroin users plus five additional subjects. The trial will: identify the range of buprenorphine doses required to alleviate heroin withdrawal symptoms; identify the patient characteristics which impact upon the medication requirements of heroin withdrawal; and examine the acceptability to patients and clinicians of a naltrexone induction protocol.
See details above of NCEPH trial of buprenorphine and naltrexone in the management of heroin withdrawal.
Australia
Although Federal Cabinet's decision of August 1997 led to the abandonment of the proposed trial of prescription heroin in the ACT, calls for a trial have persisted. Dr Alex Wodak, President of the Australian Drug Law Reform Foundation and Director of the Alcohol and Drug Service at Sydney's St Vincent's Hospital, has been an outspoken proponent of such a trial as has the ACT Health Minister Michael Moore. The Lord Mayors of Australia's capital cities, meeting recently in Brisbane, have unanimously supported trials of prescription heroin. The mayors also supported legal injecting premises for heroin users. In addition, the Western Australian branch of the National Party voted at its annual state conference in August 1998 to support a controlled trial of prescription heroin.
Overseas
Trials of legal prescription heroin have been conducted in Switzerland during the past six years. A comprehensive collection of articles and reports on the Swiss trials can be found in the Department of the Parliamentary Library's Public Issues Kit No. 1 1997-98: Alternative approaches to managing heroin use: the ACT heroin trial and the international experience.
Trials of legal prescription heroin have also received attention in other countries. For example, the Netherlands, Denmark and Luxembourg are all considering following the Swiss approach to managing heroin use. Influenced by the results of the Swiss trials, the German Medical Council unanimously resolved earlier this year that heroin should be made available by doctors to a select group of heroin users. The Council has approached the Minister for Justice to address the legal issues involved. The German Minister for Health disagrees with the Council, preferring methadone maintenance to treat heroin dependency.(14)
The Health Commissioner of Baltimore in the United States has supported calls by the John Hopkins University for a research study of prescription heroin for 'hard-core' heroin users who have failed other forms of treatment.(15) The Mayor of Baltimore was quick to make it clear that the city's administration had no intention of supporting such a project.(16)
Canada is reportedly planning to introduce trials of legal prescription heroin in several cities. Canadian scientists and doctors who are members of the North American Heroin Trial Working Group are drafting the framework for a heroin maintenance trial. Health Canada (the Canadian Health Department) agrees that research is needed in this area, while Vancouver's chief of police has also supported the moves for a trial of prescription heroin.(17)