Heavy drinking and illicit drug use common in London methadone patients - were doses adequate? Research summary by Dr Richard Hallinan.
Excessive alcohol consumption and drinking expectations among clients in methadone maintenance. Hillebrand J, Marsden J, Finch E, Strang J. Journal of Substance Abuse Treatment 2001 21;3:155-60
Dear Colleagues
This study investigated the prevalence and psychological determinants of alcohol consumption in 66 MMT clients in South London in 1999, using the framework of the Theory of Reasoned Behaviour (Ajzen and Fishbein, 1980). By a sensitive criterion of 3 or more of 8 DSM-IV markers of alcohol dependence, 54% of surveyed clients were alcohol dependent in the previous 12 months. In some cases this period could have preceded the time in MMT, which together with the sensitive criterion of alcohol dependence may have given a liberal estimate of this problem in MMT clients, however the results are consistent with many previous studies showing a high prevalence of alcohol dependency in MMT clients in the US and UK.
The study participants had been in treatment at least a month (mean 28.4 months), and were dosed at community pharmacies with a mean dose of 49mg (SD 27mg). There were also high levels of recent use of heroin (62%), stimulants (47%) and benzodiazepines (32%).
The researchers examined the clients' perceived functions for alcohol use, and found 84% used it to relax, 68% to relieve boredom, 66% to improve low mood, 64% to forget problems, 54% to help them sleep and 30% to increase the effect of methadone; 28% to get going in the morning; 24% to stop feeling sick in the morning. 24% used it to calm down after using other drugs.
The strongest predictor of clients' expectation of change in their own drinking was 'subjective norms', suggesting their susceptibility to the views of 'important others' around them, potentially including MMT staff. The use of alcohol to perform particular functions was also a strong predictor of low expectation of change, suggesting that if these specific functions could be served in other ways, clients may be more susceptible of change in their drinking behaviour. The dose of methadone was significantly and negatively related to expectation of change in drinking.
The mechanism for determination of methadone doses in this client group is not specified in the report; in particular it is not apparent whether there were actual or perceived ceilings to methadone dosing.
The MMT clients reported in this study apparently received a considerable range of doses but the mean dose was lower than the minimum 60mg daily recommended by the US National Institutes of Health consensus panel guidelines (1997). Only 35.5% of MMT clients in the US were receiving doses less than 60mg daily in 2000, down from 79.5% in 1988 (D'Aunno and Pollack 2000). Ball and Ross (1991) found that prevalence of heroin use fell to under 10% only with MMT doses higher than 50mg daily. In a study of 211 MMT patients Eap et al (2000) found a trough R,S- methadone level of 400 ng/ml was a significant therapeutic threshold with an 81% specificity for absence of heroin use, a level achievable with a mean dose of circa 80mg daily (Wolff et al 1991).
Hillebrand et al's study should thus be examined through the prism of possible underdosing, which is strongly suggested by the high prevalence of continuing heroin use. Most of the specific perceived functions of alcohol use which they identified (viz to relax, relieve low mood, get to sleep, get going or stop feeling sick in the morning, to augment the effect of methadone) could be interpreted as self medication of symptoms of abstinence. Borg et al 1995 found methadone levels under 150 ng/ml in 9 of 10 patients with such symptoms, and reported "Early opioid withdrawal, requiring a higher dose of methadone, is often difficult to diagnose because many of the symptoms are also symptoms of other syndromes common in the methadone maintenance population."
The authors identified a negative correlation of dose of methadone with expectation of change in drinking behaviour, which they speculate may reflect a greater 'attachment' to their drinking behaviour in higher dose clients. This finding needs scrutiny considering the limited information given about dosing practices. On the figures given, at least 95% of the clients had doses less than 103 mg daily (ie mean+2xSD). In a situation where there is considerable dosing flexibility within actual or perceived limits, higher dose clients are more likely to include those limited by a 'ceiling'. Thus, paradoxically, higher doses could be associated with a greater likelihood of underdosing, explaining the greater 'attachment' of some higher dose clients to their drinking. The fact that the association of high dose with lower expectation of change was independent of perceived functions of alcohol, need only imply that the function of alcohol in alleviating symptoms of abstinence is not always perceived as such.
The strongest positive predictor of expectations was found to be subjective norms, evidence of the importance of the MMT environment in addressing problematic alcohol consumption. The power of subjective norms also suggests a mechanism by which clients might limit their own doses to 'acceptable' limits and fail to perceive the extent to which alcohol is used to alleviate symptoms.
Clients who felt they were using alcohol for specific functions were less likely to expect change in their drinking. The simplest alternative to alcohol for many of the functions identified by the researchers might be methadone dose titration.
In contrast to the good evidence that adequate doses of methadone can reduce cocaine use, there is only a modest literature of observational studies suggesting the same for alcohol and benzodiazepines Byrne 1998 Maxwell and Shinderman 1999, Tennant 1987, Stimmel et al 1982, Gelkopf et al 1999. Recently Lubrano et al 2002 et al have described high levels of craving for alcohol in MMT patients receiving low doses. Hillebrand et al's simple and elegant study highlights the need for further research to evaluate the issue of adequacy of methadone dose in dealing with the important problem of alcohol use in MMT.
Comments by Dr Richard Hallinan, 75 Redfern St, Redfern, 2016
Refs:
Ajzen, I., and Fishbein, M. (1980) Understanding attitudes and predicting social behaviour. London: Prentice-Hall International.
Ball, J.C., and Ross, A. The effectiveness of Methadone Maintenance Treatment. New York: Springer-Verlag, 1991.
Borg L, Ho A, Peters JE, Kreek MJ. Availability of reliable serum methadone
determination for management of symptomatic patients. J Addict Dis 1995;14(3):83-96
Byrne, A. Use of serum levels for optimising doses in methadone maintenance treatment. J Main Addict 1998; 1: 13-4.
D'Aunno T, Pollack HA. Changes in methadone treatment practices: results from a national panel study, 1988-2000. JAMA. 2002 Aug 21;288(7):850-6.
Eap CB, Bourquin M, Martin J, Spagnoli J, Livoti S, Powell K, Baumann P, Deglon J. Plasma concentrations of the enantiomers of methadone and therapeutic response in methadone maintenance treatment. Drug Alcohol Depend. 2000 Dec 22;61(1):47-54.
Gelkopf M, Bleich A, Hayward R, Bodner G, Adelson M. Characteristics of benzodiazepine abuse in methadone maintenance treatment patients: a 1 year prospective study in an Israeli clinic. Drug Alcohol Depend. 1999 Jun 1;55(1-2):63-
Maxwell S, Shinderman M. Optimizing response to methadone maintenance treatment: use of higher-dose methadone. J Psychoactive Drugs. 1999 Apr-Jun;31(2):95-102.
Stimmel B, Hanbury R, Sturiano V, Korts D, Jackson G, Cohen M. Alcoholism as a risk factor in methadone maintenance. A randomized controlled trial. Am J Med 1982 Nov;73(5):631-6
Tennant FS Jr. Inadequate plasma concentrations in some high-dose methadone maintenance patients. Am J Psychiatry. 1987 Oct;144(10):1349-50.
Hillebrand J, Marsden J, Finch E, Strang J. Excessive alcohol consumption and drinking expectations among clients in methadone maintenance. J Subst Abuse Treat. (2001) 21(3):155-60
National Addiction Centre Institute of Psychiatry, Maudsley Hospital 4, Windsor Walk, London SE5 8AF, UK.
1 October 2003
Pharmacokinetics of high-dose buprenorphine
Drug Alc Depend (2003) 72; 1:75-83
Pharmacokinetics of high-dose buprenorphine following single administration of sublingual tablet formulations in opioid naïve healthy male volunteers under a naltrexone block. McAleer SD, Mills RJ, Polack T, Hussain T, Rolan PE, Gibbs AD, Mullins FGP, Hussein Z.
Dear Colleagues,
At last we have some real data on buprenorphine half lives, absorption and effects from healthy volunteer studies. These researchers, who were working for the manufacturers, have taken 35 healthy males and given substantial doses of buprenorphine after 50-150mg naltrexone 'block'. They then measured clinical and blood parameters at regular intervals for up to 3 days in an in-patient setting. Techniques for measuring blood levels of buprenorphine are still being developed and are not generally available in clinical practice. This makes patient history and clinical observation even more important than otherwise. A liquid chromatographic tandem mass spectrometric (LC-MS/MS) assay was developed by these researchers and it was validated for the measurement of buprenorphine and nor-buprenorphine, its metabolite, in blood.
Mean half life was found to be 26 hours with a wide range from 9 to 69. Interestingly, these authors have confirmed some observations in clinical practice including highly variable half lives and the 'bi-exponential' decay sometimes reported by patients. Some had a 'secondary peak' at about 10 hours from dosing. The authors report that some had higher levels following meals and propose 'entero-hepatic recirculation' in some cases. Maximum or 'peak' levels occurred between 30 minutes and 3 hours.
The addition of naloxone in the sublingual preparation made no difference to blood levels. The time taken for the tablets to dissolve were similar for all dose levels from 2 to 16mg (range 6-12 min) and were no different for the combination product. It is worrying that the American FDA has approved the marketing of the combination product even before research of this nature had been established. One wonders if they have different standards for drugs used in the treatment of addiction.
The authors confusingly claim to have shown that the two formulations of buprenorphine - naloxone were 'bioequivalent'. This should not be read as their being bioequivalent to the pure product which for some reason they did not test or else did not report if they did. Also, and importantly, these patients had already been given a large dose of naltrexone, a close chemical cousin of naloxone. Unsurprisingly, they found approximately half the blood levels when half the buprenorphine dose was administered. To demonstrate bioequivelence between the old pure sublingual product and a new formulation will take specific research which is yet to be done to my knowledge. The manufacturers have sponsored numerous experts who have stated that for practical clinical purposes the pure product is bio-equivalent yet this is not based on any research to my knowledge and is also very unlikely based on the small amount of research there is out there.
Thus a major weakness of the present study is that it did not examine levels in on-going treatment, but just individual single doses. Thus is it more relevant to the initiation period, which is still a major problem for some patients and is thus a helpful contribution to the scientific literature. There were no opioid effects using the naltrexone block at between 50 and 150mg doses 4 hours prior to opioid administration. This is also helpful information for those using blocking therapies, despite their limited place in normal clinical practice.
comments by Andrew Byrne ..
23 September 2003
Smoking cessation in dependency patients / Therapeutic thresholds in methadone maintenance
Tues 23 Sept 03
Presenters:
Professor Robyn Richmond. "Smoking cessation in dependency patients. What is best practice?"
Dr Richard Hallinan "Therapeutic thresholds in methadone maintenance: resolving the debate over blood levels".
Chair - Dr Bob Elliott.
Dear Colleagues,
We had another informative session at the September Concord dependency seminar when Professor Robyn Richmond from UNSW gave us a preview of the new general practice smoking cessation guidelines and their genesis. She reminded us of the prevalence of smoking in Australians at around 20% of the population, one of the lowest rates in the world. Despite very high smoking rates in the 1950s to 1960s, Australia succeeded in reductions with a combination of advertising bans, education, price policy and treatment availability. Yet smoking is still the biggest cause of preventable pathology and premature deaths in our population.
Around a third of smokers do not want to address their dependency and are 'pre-contemplators' regarding abstinence programs. But this still leaves a substantial proportion of smokers who are amenable to intervention. We now know from careful research that 'brief interventions' actually succeed in terms of yielding more non-smokers in 6 to 12 months, especially when there is active follow-up (see this week's MJA on the subject). General practice is one of the few places where 'opportunistic' interventions such as this can be done when smokers attend for a variety of other reasons, usually unrelated to tobacco addiction.
Professor Richmond told us that good statistics are now available for tobacco use as well as responses to the various evidence based interventions which are being promulgated in the new National Guidelines. On average, about 40% of 'successful' quitters will have taken up the habit again by one year. This emphasises the importance of follow up and preventive measures. We were told that although they may help some people, non-evidence based treatments such as acupuncture or hypnotherapy will not be included in the current guidelines.
As doctors, pharmacists and other health care workers, we were encouraged to inform all our smokers that help was available when they were ready to quit using nicotine replacement therapy (gums and patches) and buproprion tablets (Zyban). Professor Richmond said that there are some new 'commercial in confidence' drugs on the way and we should have even more modalities in the coming years. Nicotine patches can become a longer-term habit in about 10% of cases but this was thought to be overshadowed by the great benefits of the others who often manage to become abstinent for long periods, or even permanently.
We were advised to address smoking from the individual's perspective and ask what people actually found positive and pleasurable about smoking and what they found negative such a cost, health consequences, halitosis, etc. This allowed the patient to focus and reflect on their own habit and its consequences. Some anatomical photographs of lung cancer cases, blocked arteries, etc made good theatrical props and will be included in the package to GPs which are now being trialled.
In the second half Dr Richard Hallinan spoke of taking a history, examination and, occasionally, blood testing for detecting fast metabolizers in methadone maintenance therapy. He spoke of Professor Chin Eap's masterly review of the subject and his finding of a 'threshold' for blood levels which was consistent at around 0.4mg/l. Above this level regular heroin use is exceptional, making dose increases a serious option for those with lower levels, given that there is no clinical toxicity.
Dr Hallinan brought us face to face with a large group of published research relating to the absorption, portal availability, protein binding, hepatic and other metabolism and excretion of methadone. He pointed out the differences between methadone and many other drugs we use in medical practice as well as some of the similarities. He is presently working on a study of left and right stereoisomers of methadone (to use outdated terminology) and will bring us up to speed on that subject, including the new terms at the next seminar.
Summary by Andrew Byrne ..
3 September 2003
Supervised injecting room called for in Redfern
Dear Colleagues,
On Sunday a public meeting was held in Redfern to discuss the need for an injecting room in the area. It was chaired by South Sydney Mayor Tony Pooley and had speakers Dr Ingrid van Beek, Rev Ray Richmond, Rev Bill Crewes and Councillor Shayne Mallard. There were 45 people in attendance including representatives of the communities, Aboriginal Medical Service, local pharmacy, housing and local residents from Waterloo, Redfern and 'the block'.
There appeared to be no opposition to the concept of an injecting room but some lively debate occurred on where it might be located and how the police might react to it all. Police Service support for the Kings Cross injecting facility has been instrumental in its success.
Dr van Beek and other speakers were at pains to state that the lessons from Kings Cross did not necessarily translate directly to other areas where needs may be different. They had proved that such a service could operate successfully without disrupting the local community or business. Support had actually risen significantly during the 2 years of the trial according to independent polling (from 68 to 78% among residents and 58 to 63% for businesses). Apparently, only 1% of over 200 businesses polled reported adverse effects due to the injecting centre.
A resident from Eveleigh Street spoke passionately of the 'village' atmosphere which is potentially poisoned by the constant visible drug dealing and using. A man from Wilson Street also supported the injecting room concept to 'disconnect' the 'normal' use of needles seen by local children all around them. It was stated that there had been over 100 deaths in the Eveleigh-Abercrombie-Cleveland Street triangle in the past 3 years. It was debated just how many of the users were locals and what proportion were from Aboriginal backgrounds. Then it was generally agreed that they were all using drugs in our area and thus a local facility stood to help both the users and the local community, regardless of the backgrounds or origins of the users involved.
Most informed discussion since the release of the independent report into the Kings Cross "MSIC" has been very positive and it has been granted almost permanent status with another 4 year licence extension this week. Some debate has occurred on just how many deaths were prevented and at what cost. Such debate should focus on how to save more lives and how to be more cost effective in service delivery, yet some commentators have taken the consistent stand that it should be closed forthwith! Gross differences between the 'average' Australian drug user and the folk who use the trial injecting facility would seem to invalidate simple statistical comparisons.
I visit the Kings Cross injecting centre each week and have been struck by the 'ordinary' nature of its operation. Despite the rather brutal and potentially dangerous injecting behaviour which goes on in private in the 'middle' room, the entry assessment and waiting areas are always pleasant and businesslike with an almost complete lack of tension, high spirits or confrontation. The staff are invariably patient and yet firm with the assessment process which takes between two and ten minutes. After declaring what drugs they intend to use and when their last injection was, patients/clients may inject under supervision of nursing staff. The staff may give advice on injecting practices, vein care or other health matters, but they may NOT assist with actual injecting. Drug 'sharing' in the facility it not permitted.
The results speak for themselves and it is to be hoped that a consensus will be found for an injecting facility for the many people at risk as well as the community of Redfern and adjacent suburbs in the very near future. There seemed to be a general agreement at the public meeting on 31 August that such a medically supervised service should be within easy walking distance of 'the block' but probably not on 'the block' itself. This leaves the streets close to busy Redfern Station (10 tracks plus subway) as the most likely contenders. It would be no coincidence that a successful injecting facility would again be close to a hub of transport where it seems to disrupt other business less than the drug dealing and public using which is already going on, almost unchecked. I live one short block from the Kings Cross facility and it has improved matters for local residents here without doubt.
It is no longer possible to argue against the concept of injecting facilities without undervaluing the lives of drug users. They have been used for up to 15 years in several countries and they constitute one useful strategy to stem the toll from drug use in our society. Some of the victims of drug overdose are occasional or relatively recent users who may not be amenable to any other intervention and some may not even be addicted. Overdose death is the most recognisable complication of drug use but for every overdose death, we know that there is a proportionate number of non-fatal yet serious complications as well as viral infections from unclean injecting practices and the crime, poverty and ill health which accompanies street drug use.
On Sunday a public meeting was held in Redfern to discuss the need for an injecting room in the area. It was chaired by South Sydney Mayor Tony Pooley and had speakers Dr Ingrid van Beek, Rev Ray Richmond, Rev Bill Crewes and Councillor Shayne Mallard. There were 45 people in attendance including representatives of the communities, Aboriginal Medical Service, local pharmacy, housing and local residents from Waterloo, Redfern and 'the block'.
There appeared to be no opposition to the concept of an injecting room but some lively debate occurred on where it might be located and how the police might react to it all. Police Service support for the Kings Cross injecting facility has been instrumental in its success.
Dr van Beek and other speakers were at pains to state that the lessons from Kings Cross did not necessarily translate directly to other areas where needs may be different. They had proved that such a service could operate successfully without disrupting the local community or business. Support had actually risen significantly during the 2 years of the trial according to independent polling (from 68 to 78% among residents and 58 to 63% for businesses). Apparently, only 1% of over 200 businesses polled reported adverse effects due to the injecting centre.
A resident from Eveleigh Street spoke passionately of the 'village' atmosphere which is potentially poisoned by the constant visible drug dealing and using. A man from Wilson Street also supported the injecting room concept to 'disconnect' the 'normal' use of needles seen by local children all around them. It was stated that there had been over 100 deaths in the Eveleigh-Abercrombie-Cleveland Street triangle in the past 3 years. It was debated just how many of the users were locals and what proportion were from Aboriginal backgrounds. Then it was generally agreed that they were all using drugs in our area and thus a local facility stood to help both the users and the local community, regardless of the backgrounds or origins of the users involved.
Most informed discussion since the release of the independent report into the Kings Cross "MSIC" has been very positive and it has been granted almost permanent status with another 4 year licence extension this week. Some debate has occurred on just how many deaths were prevented and at what cost. Such debate should focus on how to save more lives and how to be more cost effective in service delivery, yet some commentators have taken the consistent stand that it should be closed forthwith! Gross differences between the 'average' Australian drug user and the folk who use the trial injecting facility would seem to invalidate simple statistical comparisons.
I visit the Kings Cross injecting centre each week and have been struck by the 'ordinary' nature of its operation. Despite the rather brutal and potentially dangerous injecting behaviour which goes on in private in the 'middle' room, the entry assessment and waiting areas are always pleasant and businesslike with an almost complete lack of tension, high spirits or confrontation. The staff are invariably patient and yet firm with the assessment process which takes between two and ten minutes. After declaring what drugs they intend to use and when their last injection was, patients/clients may inject under supervision of nursing staff. The staff may give advice on injecting practices, vein care or other health matters, but they may NOT assist with actual injecting. Drug 'sharing' in the facility it not permitted.
The results speak for themselves and it is to be hoped that a consensus will be found for an injecting facility for the many people at risk as well as the community of Redfern and adjacent suburbs in the very near future. There seemed to be a general agreement at the public meeting on 31 August that such a medically supervised service should be within easy walking distance of 'the block' but probably not on 'the block' itself. This leaves the streets close to busy Redfern Station (10 tracks plus subway) as the most likely contenders. It would be no coincidence that a successful injecting facility would again be close to a hub of transport where it seems to disrupt other business less than the drug dealing and public using which is already going on, almost unchecked. I live one short block from the Kings Cross facility and it has improved matters for local residents here without doubt.
It is no longer possible to argue against the concept of injecting facilities without undervaluing the lives of drug users. They have been used for up to 15 years in several countries and they constitute one useful strategy to stem the toll from drug use in our society. Some of the victims of drug overdose are occasional or relatively recent users who may not be amenable to any other intervention and some may not even be addicted. Overdose death is the most recognisable complication of drug use but for every overdose death, we know that there is a proportionate number of non-fatal yet serious complications as well as viral infections from unclean injecting practices and the crime, poverty and ill health which accompanies street drug use.
Comments by Andrew Byrne ..
8 August 2003
Smoking cessation randomised controlled trial using gums, clonidine or naltrexone
Ahmadi J, Ashkani H, Ahmadi M, Ahmadi N. Twenty-four week maintenance treatment of cigarette smoking with nicotine gum, clonidine and naltrexone. J Subst Abuse Treat (2003) 24;3:251-255
Dear Colleagues,
This paper describes a simple three-way pharmacotherapeutic intervention for smoking cessation using nicotine gums, clonidine or naltrexone. In three randomised groups each of 60 would-be quitters, these researchers gave double blind treatments to see how many folk dropped out and how many managed to abstain from smoked nicotine over a six month period.
The results are of great interest and relevance to clinical practice, confirming some things we believed and showing some other novel findings. After 24 weeks of the study, abstinence rates were 37% for the nicotine gum group, 19% for the clonidine group and 5% for those given naltrexone, each finding being significantly different from the others.
The authors state that this supports the use of NRT (nicotine replacement therapy) and at the same time questions the utility of naltrexone for smoking cessation, which had mixed reports from previous literature reports.
The rate of significant side effects was 42% in those on NRT, 32% for clonidine and 84% for those taking naltrexone tablets (50mg daily). These were largely headache, GI upset, and sleep disturbances. Some of the 'side effects' may have been nicotine withdrawals.
It would seem that naltrexone has been tried for many conditions including anorexia and bulimia. I have prescribed it with consent for severe cannabis dependence patients with mixed results. Despite its consistently good results with alcoholism, other substance or behavioural disturbances seem less amenable to its antagonist effects.
comments by Andrew Byrne ..
Dear Colleagues,
This paper describes a simple three-way pharmacotherapeutic intervention for smoking cessation using nicotine gums, clonidine or naltrexone. In three randomised groups each of 60 would-be quitters, these researchers gave double blind treatments to see how many folk dropped out and how many managed to abstain from smoked nicotine over a six month period.
The results are of great interest and relevance to clinical practice, confirming some things we believed and showing some other novel findings. After 24 weeks of the study, abstinence rates were 37% for the nicotine gum group, 19% for the clonidine group and 5% for those given naltrexone, each finding being significantly different from the others.
The authors state that this supports the use of NRT (nicotine replacement therapy) and at the same time questions the utility of naltrexone for smoking cessation, which had mixed reports from previous literature reports.
The rate of significant side effects was 42% in those on NRT, 32% for clonidine and 84% for those taking naltrexone tablets (50mg daily). These were largely headache, GI upset, and sleep disturbances. Some of the 'side effects' may have been nicotine withdrawals.
It would seem that naltrexone has been tried for many conditions including anorexia and bulimia. I have prescribed it with consent for severe cannabis dependence patients with mixed results. Despite its consistently good results with alcoholism, other substance or behavioural disturbances seem less amenable to its antagonist effects.
comments by Andrew Byrne ..
Heroin trials - old and new.
HEROIN TRIALS - AN ABRIDGED HISTORY - AND A DUTCH ADDITION.
van den Brink W, Hendriks VM, Blanken P, Koeter MWJ, van Zwieten BJ, van Ree JM. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials. BMJ 2003;327 310-0
Dear Colleagues,
It is fascinating to track the history of heroin prescription over the past 25 years. We first find an English report in an American journal. Next, almost 20 years later came another English description in an Australian journal. After that the major Swiss trials were reported in Anglo-American journals while this latest Dutch trial is in the BritishMedical Journal. It is indeed a global problem.
Most of these trials took treatment resistant heroin addicts and permitted pharmaceutical heroin to be injected with supervision under trial conditions. Some used comparisons with methadone but one used a six month delay as a 'chronological control' group. Patients were permitted realistically high doses of heroin, consistent with their pre-treatment street use, up to one gram daily. There were small trials of 30 to 50 patients such as Perneger and Hartnoll, while the main Swiss trial enrolled 1146 subjects.
There was a practice of prescribing morphine and heroin to addicted patients in the US, England and probably Australia prior to the 1940s but records have been lost and details are mired in history and even mythology. The Swedish prescribing of stimulants in the 1960s was similar in some ways. There appeared to be no prominence of adverse reports from coroners or others at the time but little else can be gleaned from a scientific stand point. There were reports of rapid opiate detoxification (bromides) under sedation from Hong Kong in the British Medical Journal of 1899 and at least one death was reported from that era.
The report by van der Brink and colleagues in the British Medical Journal describes 550 methadone patients who were still using illicit heroin in 6 Dutch cities. They were randomised either to remain in methadone treatment or to receive heroin (injectable if they usually injected, inhaled powder if they normally inhaled - making two separate trials). Despite being allowed up to a gram per day in three divided doses, patients chose to take only half that in an average of 2 daily supervised doses. The mean methadone dose was around 70mg daily, with a maximum permitted of 150mg. Although higher than average doses in some areas, this was probably still inadequate, just as occurs with methadone patients in every country.
Follow-up rates were as high as 95%. Outcomes of numerous aspects of social, mental and physical integration were examined by independent researchers using a modified Addiction Severity Index (ASI). Improvements were marked in both groups but almost twice as much in the groups permitted heroin as well as methadone (~45% vs. ~25% 'response' rate = 40% improvement in ASI). The differences were significant. The rather unfortunate end to the trial was a compulsory 2 months without prescribed heroin, during which the good progress was reversed.
Those decrying a heroin trial in Australia are just delaying the inevitable while the consequences of unchecked drug use cause untold damage to the security and prosperity of our community. There has been no report of increased drug addiction or other adverse sequelae of drug use in regions where heroin has been prescribed. Also, in the largest and longest controlled trial in Switzerland, only a small expansion has occurred, disproving any 'floodgates' effect. Politicians should note that a referendum on such policies was resoundingly successful, especially in the older age groups.
Comments by Andrew Byrne ..
Hartnoll RL, Mitchelson MC, Battersby A, Brown G, Ellis M, Fleming P, HedleyN. Evaluation of Heroin Maintenance in Controlled Trial. Arch Gen Psychiatry1980 37:877-84.
Metrebian N, Shanahan W, Wells B, Stimson GV. Feasibility of prescribinginjectable heroin and methadone to opiate-dependent drug users: associatedhealth gains and harm reductions. 1998 Med J Aust 168:596-600
Perneger TV, Giner F, del Rio M, Mino A. Randomised trial of heroinmaintenance programme for addicts who fail in conventional drugtreatments. BMJ 1998;317:13-18
Ali R, Auriacombe M, Casas M, Cottler L, Farrel M, Kleiber D, et al.Report of the external panel on the evaluation of the swiss scientificstudies of medically prescribed narcotics to drug addicts. Sucht1999;45: 160-70
Rehm J, Gschwend P, Steffen T, Gutzwiller F, Dobler-Mikola A,Uchtenhagen A. Feasibility, safety, and efficacy of injectable heroinprescription for refractory opioid addicts: a follow-up study. Lancet2001;358: 1417-20
Haemmig RB, Tschacher W. Effects of high-dose heroin versus morphine inintravenous drug users: a randomised double-blind crossover study. JPsychoactive Drugs 2001 Apr-Jun;33(2):105-10
van den Brink W, Hendriks VM, Blanken P, Koeter MWJ, van Zwieten BJ, van Ree JM. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials. BMJ 2003;327 310-0
Dear Colleagues,
It is fascinating to track the history of heroin prescription over the past 25 years. We first find an English report in an American journal. Next, almost 20 years later came another English description in an Australian journal. After that the major Swiss trials were reported in Anglo-American journals while this latest Dutch trial is in the BritishMedical Journal. It is indeed a global problem.
Most of these trials took treatment resistant heroin addicts and permitted pharmaceutical heroin to be injected with supervision under trial conditions. Some used comparisons with methadone but one used a six month delay as a 'chronological control' group. Patients were permitted realistically high doses of heroin, consistent with their pre-treatment street use, up to one gram daily. There were small trials of 30 to 50 patients such as Perneger and Hartnoll, while the main Swiss trial enrolled 1146 subjects.
There was a practice of prescribing morphine and heroin to addicted patients in the US, England and probably Australia prior to the 1940s but records have been lost and details are mired in history and even mythology. The Swedish prescribing of stimulants in the 1960s was similar in some ways. There appeared to be no prominence of adverse reports from coroners or others at the time but little else can be gleaned from a scientific stand point. There were reports of rapid opiate detoxification (bromides) under sedation from Hong Kong in the British Medical Journal of 1899 and at least one death was reported from that era.
The report by van der Brink and colleagues in the British Medical Journal describes 550 methadone patients who were still using illicit heroin in 6 Dutch cities. They were randomised either to remain in methadone treatment or to receive heroin (injectable if they usually injected, inhaled powder if they normally inhaled - making two separate trials). Despite being allowed up to a gram per day in three divided doses, patients chose to take only half that in an average of 2 daily supervised doses. The mean methadone dose was around 70mg daily, with a maximum permitted of 150mg. Although higher than average doses in some areas, this was probably still inadequate, just as occurs with methadone patients in every country.
Follow-up rates were as high as 95%. Outcomes of numerous aspects of social, mental and physical integration were examined by independent researchers using a modified Addiction Severity Index (ASI). Improvements were marked in both groups but almost twice as much in the groups permitted heroin as well as methadone (~45% vs. ~25% 'response' rate = 40% improvement in ASI). The differences were significant. The rather unfortunate end to the trial was a compulsory 2 months without prescribed heroin, during which the good progress was reversed.
Those decrying a heroin trial in Australia are just delaying the inevitable while the consequences of unchecked drug use cause untold damage to the security and prosperity of our community. There has been no report of increased drug addiction or other adverse sequelae of drug use in regions where heroin has been prescribed. Also, in the largest and longest controlled trial in Switzerland, only a small expansion has occurred, disproving any 'floodgates' effect. Politicians should note that a referendum on such policies was resoundingly successful, especially in the older age groups.
Comments by Andrew Byrne ..
Hartnoll RL, Mitchelson MC, Battersby A, Brown G, Ellis M, Fleming P, HedleyN. Evaluation of Heroin Maintenance in Controlled Trial. Arch Gen Psychiatry1980 37:877-84.
Metrebian N, Shanahan W, Wells B, Stimson GV. Feasibility of prescribinginjectable heroin and methadone to opiate-dependent drug users: associatedhealth gains and harm reductions. 1998 Med J Aust 168:596-600
Perneger TV, Giner F, del Rio M, Mino A. Randomised trial of heroinmaintenance programme for addicts who fail in conventional drugtreatments. BMJ 1998;317:13-18
Ali R, Auriacombe M, Casas M, Cottler L, Farrel M, Kleiber D, et al.Report of the external panel on the evaluation of the swiss scientificstudies of medically prescribed narcotics to drug addicts. Sucht1999;45: 160-70
Rehm J, Gschwend P, Steffen T, Gutzwiller F, Dobler-Mikola A,Uchtenhagen A. Feasibility, safety, and efficacy of injectable heroinprescription for refractory opioid addicts: a follow-up study. Lancet2001;358: 1417-20
Haemmig RB, Tschacher W. Effects of high-dose heroin versus morphine inintravenous drug users: a randomised double-blind crossover study. JPsychoactive Drugs 2001 Apr-Jun;33(2):105-10
Spanish group's experience with naltrexone implants.
Spanish group's experience with naltrexone implants. 'AddictionBiology' report.
Maintenance treatment with depot opioid antagonists in subcutaneousimplants: an alternative in the treatment of opioid dependence. Carren JE,Alvarez CE, San Narciso GI, Bascaran MT, Diaz M, Bobes J. Addiction Biology(2003) 8, 429-438
Dear Colleagues,
In this paper a group of Spanish naltrexone enthusiasts report on 156patients, nearly all male, who were treated with a rapid opioiddetoxification process followed by a naltrexone implant. It is due to the‘open’ policies of the editors of Addiction Biology that they are preparedto publish such papers. Research of this nature would be unlikely tosurvive the strict new ‘Farmington’ editorial rigours of the NAC ‘sister’journal, Addiction, edited by Griffith Edwards.
These researchers’ main finding is a two year follow-up with 4 six-monthlyretention rates of 80%, 65%, 55% and 21% “all of them remaining abstinent toopioids.” “It is concluded that the programme is safe for the patients andshows a better retention index than programmes using oral antagonists, withan improved compliance (negative urine analysis) compared to the latter.”Thus, although 80% of patients are lost to follow-up the authors seemconfident to report comparative results.
The authors also allow us to compare these naltrexone treated patients withthose prescribed methadone. Their reported statistics show only very minordifferences in social, drug use and other demographics over the 24 monthsfrom starting the treatment. This is in stark contrast to methadone andbuprenorphine patients who generally report dramatic and sustainedimprovements in employment, housing, drug use and criminal statistics afterjoining treatment. Indeed, despite finding a worrying increase in alcoholconsumption (mean 50%) over the period, the Spanish authors do not address this.It is also unfortunate that the authors of this naltrexone study do not givetheir specific clinical indications for the use of an experimental treatmentin preference to methadone or buprenorphine treatments which are the normal ‘gold standards’ for unstable opiate addiction in most western countries. At one point they give the feeble and almost embarrassing information thatnaltrexone is beneficial over methadone because it has no drug interactions,apart from the obvious one (the effects of opioids are negated in patients on naltrexone).
In our practice we have prescribed naltrexone to many patients over the years with a small number doing well for limited periods taking the oral formulation. Our indication for the use of naltrexone is for stronglymotivated patients seeking abstinence and who have faired poorly on agonist treatments. There is also a proportion of addicts who refuse to takemethadone and buprenorphine but their success rates on naltrexone do not seem to be any better than the others, the majority relapsing after stopping the medication, whether oral or implanted.
There may be sub-groups who do well with naltrexone but as long as research is done by ‘enthusiasts’ for the treatment in an undiscriminating manner, we will never learn what those subgroups are. Only randomised controlled research can resolve this question and the few such trials that there are to date using naltrexone are not encouraging for its use in non-selected opioid dependent patients.
Comments by Andrew Byrne ..
Maintenance treatment with depot opioid antagonists in subcutaneousimplants: an alternative in the treatment of opioid dependence. Carren JE,Alvarez CE, San Narciso GI, Bascaran MT, Diaz M, Bobes J. Addiction Biology(2003) 8, 429-438
Dear Colleagues,
In this paper a group of Spanish naltrexone enthusiasts report on 156patients, nearly all male, who were treated with a rapid opioiddetoxification process followed by a naltrexone implant. It is due to the‘open’ policies of the editors of Addiction Biology that they are preparedto publish such papers. Research of this nature would be unlikely tosurvive the strict new ‘Farmington’ editorial rigours of the NAC ‘sister’journal, Addiction, edited by Griffith Edwards.
These researchers’ main finding is a two year follow-up with 4 six-monthlyretention rates of 80%, 65%, 55% and 21% “all of them remaining abstinent toopioids.” “It is concluded that the programme is safe for the patients andshows a better retention index than programmes using oral antagonists, withan improved compliance (negative urine analysis) compared to the latter.”Thus, although 80% of patients are lost to follow-up the authors seemconfident to report comparative results.
The authors also allow us to compare these naltrexone treated patients withthose prescribed methadone. Their reported statistics show only very minordifferences in social, drug use and other demographics over the 24 monthsfrom starting the treatment. This is in stark contrast to methadone andbuprenorphine patients who generally report dramatic and sustainedimprovements in employment, housing, drug use and criminal statistics afterjoining treatment. Indeed, despite finding a worrying increase in alcoholconsumption (mean 50%) over the period, the Spanish authors do not address this.It is also unfortunate that the authors of this naltrexone study do not givetheir specific clinical indications for the use of an experimental treatmentin preference to methadone or buprenorphine treatments which are the normal ‘gold standards’ for unstable opiate addiction in most western countries. At one point they give the feeble and almost embarrassing information thatnaltrexone is beneficial over methadone because it has no drug interactions,apart from the obvious one (the effects of opioids are negated in patients on naltrexone).
In our practice we have prescribed naltrexone to many patients over the years with a small number doing well for limited periods taking the oral formulation. Our indication for the use of naltrexone is for stronglymotivated patients seeking abstinence and who have faired poorly on agonist treatments. There is also a proportion of addicts who refuse to takemethadone and buprenorphine but their success rates on naltrexone do not seem to be any better than the others, the majority relapsing after stopping the medication, whether oral or implanted.
There may be sub-groups who do well with naltrexone but as long as research is done by ‘enthusiasts’ for the treatment in an undiscriminating manner, we will never learn what those subgroups are. Only randomised controlled research can resolve this question and the few such trials that there are to date using naltrexone are not encouraging for its use in non-selected opioid dependent patients.
Comments by Andrew Byrne ..
BMJ report on less methadone ampoules/tablets but more oral liquid prescribed over 12 years
Strang J, Sheridan J. Effect of national guidelines on prescription of methadone: analysis of NHS prescription data, England 1990-2001 BMJ (2003) 327: 321 - 322
Dear Colleagues,
This intriguing item claims to examine the results of published English clinical guidelines yet it only examines 2 minor outcomes, and then not how these were achieved. On examining NHS prescriptions the authors found that the use of methadone tablets and ampoules had dropped by around 50% in a decade. Without examining clinical details, they assume that both of these outcomes were favourable, and that further, the changes were necessarily a result of their own published dependency guidelines which were circulated to GPs in 1996 and in 1999 (see title of article). The number of prescriptions for methadone overall increased, each year, albeit unevenly, tripling over a 12 year period to 2001. We are not told the duration of such prescriptions, nor what proportion of patients were in continuous maintenance treatment or detoxification regimens.
The same issue of BMJ contains a positive descriptive item on prescribed heroin from Holland, so injectable methadone may equally have a place in legitimate clinical practice. It was reported that less than 10% of all treatment in England utilises injectables. Methadone tablets, likewise, may have a useful if small place in dependency treatment where other measures have failed. Hence a blanket edict against such treatment may not be appropriate, despite neither tablets nor ampoules being standard, evidence-based approaches.
It is disappointing that these veteran researchers, while giving a small glimmer of potentially good news, ignored an examination of the dose levels on these prescriptions as well as the degree of supervision given, or not given. Their own guidelines recommend 60mg as a minimum effective daily dose for most patients, yet it is said that *average* doses in England are below 50mg daily. Very little methadone in England is taken under supervision, although the words ‘supervise’ or ‘supervision’ are used up to 50 times in the ‘Orange Guidelines’, written by a panel chaired by Strang.
Many pharmacists in Scotland now regularly supervise methadone doses as recommended in Strang’s highly regarded guidelines. It is possible that the Scots even go ‘too far’ in daily dose supervision, just as English pharmacists seem to avoid it altogether for obscure reasons. The nature of addiction involves a lack of control over drug use, thus making supervision an important plank of any treatment strategy. It is disappointing that the originators of these impressive dependency guidelines have still not stated in unequivocal terms that their many English colleagues are systematically undermining good clinical work by ignoring evidence and giving poor quality treatment to their patients. In certain cases it may be worse than giving no treatment at all. Improved treatment would simply require endorsing prescriptions with a careful but adequate dosing schedule - and a request for a certain proportion of doses to be ‘supervised’.
Comments by Andrew Byrne ..
Dear Colleagues,
This intriguing item claims to examine the results of published English clinical guidelines yet it only examines 2 minor outcomes, and then not how these were achieved. On examining NHS prescriptions the authors found that the use of methadone tablets and ampoules had dropped by around 50% in a decade. Without examining clinical details, they assume that both of these outcomes were favourable, and that further, the changes were necessarily a result of their own published dependency guidelines which were circulated to GPs in 1996 and in 1999 (see title of article). The number of prescriptions for methadone overall increased, each year, albeit unevenly, tripling over a 12 year period to 2001. We are not told the duration of such prescriptions, nor what proportion of patients were in continuous maintenance treatment or detoxification regimens.
The same issue of BMJ contains a positive descriptive item on prescribed heroin from Holland, so injectable methadone may equally have a place in legitimate clinical practice. It was reported that less than 10% of all treatment in England utilises injectables. Methadone tablets, likewise, may have a useful if small place in dependency treatment where other measures have failed. Hence a blanket edict against such treatment may not be appropriate, despite neither tablets nor ampoules being standard, evidence-based approaches.
It is disappointing that these veteran researchers, while giving a small glimmer of potentially good news, ignored an examination of the dose levels on these prescriptions as well as the degree of supervision given, or not given. Their own guidelines recommend 60mg as a minimum effective daily dose for most patients, yet it is said that *average* doses in England are below 50mg daily. Very little methadone in England is taken under supervision, although the words ‘supervise’ or ‘supervision’ are used up to 50 times in the ‘Orange Guidelines’, written by a panel chaired by Strang.
Many pharmacists in Scotland now regularly supervise methadone doses as recommended in Strang’s highly regarded guidelines. It is possible that the Scots even go ‘too far’ in daily dose supervision, just as English pharmacists seem to avoid it altogether for obscure reasons. The nature of addiction involves a lack of control over drug use, thus making supervision an important plank of any treatment strategy. It is disappointing that the originators of these impressive dependency guidelines have still not stated in unequivocal terms that their many English colleagues are systematically undermining good clinical work by ignoring evidence and giving poor quality treatment to their patients. In certain cases it may be worse than giving no treatment at all. Improved treatment would simply require endorsing prescriptions with a careful but adequate dosing schedule - and a request for a certain proportion of doses to be ‘supervised’.
Comments by Andrew Byrne ..
7 July 2003
Benzodiazepine dependence - randomised reduction study.
In-patient benzodiazepine withdrawal: comparison of fixed and symptom triggered taper methods. McGregor C, Machin A, White JM. Drug and Alcohol Review (2003) 22:175-180
Dear Colleagues,
This group from Adelaide University has come up with yet another instructive study of great clinical relevance. Benzodiazepine dependence has been neglected for too long. Considering the substantial profits made by drug companies it is disappointing (cynics may say predictable) that so little funding has been given to the potential for harm from benzodiazepines in vulnerable populations such as the elderly and recreational drug users.
The authors remind us that although many treatment agencies give supervised tapering doses of diazepam, this procedure has not been systematically evaluated. As with nicotine, opiates and even stimulants, such therapeutic substitutions and subsequent reductions can be a feasible way of addressing dependency management. Longer term drug maintenance is a 'fall back' position, generally using long acting, oral forms with low toxicity, in cases where reductions repeatedly result in relapse.
This study showed no significant differences between those given fixed reductions versus symptom initiated dosing with diazepam. The intervention demonstrated numerous positive outcomes at one month follow-up in such poly-drug users up to a month after treatment. Patients had used a spectacular daily mean 'Valium-equivalent' of 115mg or 23 tablets! Two thirds were using more than one type of sedative on the week of admission. At least half of the 44 subjects were also opioid habitués. The mean hospital stay was 5 days, with subsequent tapering doses offered as outpatient treatment. At the end of one month, sedative use had declined dramatically from previous levels.
We know from the British 'NTORS' research and other opioid studies that even poor quality, non-evidence-based treatments can yield positive outcomes. Hence there still needs to be much more comparative work with benzodiazepine addiction. In the meantime, either of the treatments offered in this study would seem to be appropriate, safe and effective, at least in the short term. The fixed dose regimen started with an estimated equivalent up to 80mg diazepam daily in four divided doses, reducing at 10mg daily down to 40mg and by 5mg daily thereafter. Although supervised consumption is preferable, excessive supervision may cause patients to drop out. Also, hospital admission is neither acceptable nor necessary for the majority in community practice.
In our own practice, we have found that daily attendance with supervised dosing is suitable for patients whose drug use is chaotic. Later, second or third daily attendance can suffice as patients demonstrate features of stability. A small proportion seem to need to continue daily doses of diazepam indefinitely. Some may have pre-existing anxiety or panic disorders and a proportion may have unacceptable withdrawal symptoms. This distinction may become blurred with time, but the required treatment may be the same for either diagnosis.
comments by Andrew Byrne ..
Dear Colleagues,
This group from Adelaide University has come up with yet another instructive study of great clinical relevance. Benzodiazepine dependence has been neglected for too long. Considering the substantial profits made by drug companies it is disappointing (cynics may say predictable) that so little funding has been given to the potential for harm from benzodiazepines in vulnerable populations such as the elderly and recreational drug users.
The authors remind us that although many treatment agencies give supervised tapering doses of diazepam, this procedure has not been systematically evaluated. As with nicotine, opiates and even stimulants, such therapeutic substitutions and subsequent reductions can be a feasible way of addressing dependency management. Longer term drug maintenance is a 'fall back' position, generally using long acting, oral forms with low toxicity, in cases where reductions repeatedly result in relapse.
This study showed no significant differences between those given fixed reductions versus symptom initiated dosing with diazepam. The intervention demonstrated numerous positive outcomes at one month follow-up in such poly-drug users up to a month after treatment. Patients had used a spectacular daily mean 'Valium-equivalent' of 115mg or 23 tablets! Two thirds were using more than one type of sedative on the week of admission. At least half of the 44 subjects were also opioid habitués. The mean hospital stay was 5 days, with subsequent tapering doses offered as outpatient treatment. At the end of one month, sedative use had declined dramatically from previous levels.
We know from the British 'NTORS' research and other opioid studies that even poor quality, non-evidence-based treatments can yield positive outcomes. Hence there still needs to be much more comparative work with benzodiazepine addiction. In the meantime, either of the treatments offered in this study would seem to be appropriate, safe and effective, at least in the short term. The fixed dose regimen started with an estimated equivalent up to 80mg diazepam daily in four divided doses, reducing at 10mg daily down to 40mg and by 5mg daily thereafter. Although supervised consumption is preferable, excessive supervision may cause patients to drop out. Also, hospital admission is neither acceptable nor necessary for the majority in community practice.
In our own practice, we have found that daily attendance with supervised dosing is suitable for patients whose drug use is chaotic. Later, second or third daily attendance can suffice as patients demonstrate features of stability. A small proportion seem to need to continue daily doses of diazepam indefinitely. Some may have pre-existing anxiety or panic disorders and a proportion may have unacceptable withdrawal symptoms. This distinction may become blurred with time, but the required treatment may be the same for either diagnosis.
comments by Andrew Byrne ..
Buprenorphine comparison office-based vs. clinic no differences!
A comparison of buprenorphine treatment in clinic and primary care settings: a randomised trial. Gibson AE, Doran CM, Bell JR, Ryan A, Lintzeris N. MJA 2003 179;1:38-42
Dear Colleagues,
This trial of buprenorphine for heroin addiction has shown for the first time, to my knowledge, that agonist treatment can be given in primary care settings with results equivalent to those obtained in specialist clinics when patients are randomised at enrolment.
These researchers randomised 115 consenting heroin addicts who were seeking detoxification and offered them a 5 day course of buprenorphine in community practice or clinic practice. After two days without medication (days 6 and 7), they were given an option to transfer to maintenance therapy on day 8.
About 75% of patients returned at day 8, and one third of them chose to have no further drug treatment. Of the other two thirds, all but 4 chose buprenorphine maintenance (2 went onto methadone while another 2 chose naltrexone). It is to the credit of these researchers that of the 64/115 (56% of original group) who started maintenance, 40 (35%) remained in treatment at 3 months. This is a derived retention rate of 62% for continuing patients by my calculations.
There were no significant differences in any of the measures between the primary care group and the clinic group. Costs were also similar. The medication was administered in the doctors' offices for the primary care cases and at the clinic dispensary for the clinic patients during the detoxification phase (doctors are permitted to administer S8 drugs 'in the normal course of medical practice' as long as they comply with appropriate local legislative requirements for documentation, etc). For the maintenance phase, prescriptions were filled at community pharmacies where patients paid $25 per week, contrasting with the clinics which were free of charge, making the outcomes for primary care even more impressive. There must be some doubt about some of the authors' derived conclusions regarding comparative costings owing to the necessarily approximate nature of the figures between private and public sectors.
The nature of this trial was rather unusual as it offered subjects the prospect of one thing (opioid detoxification) but ended up by giving most subjects quite the opposite (opioid maintenance). The rationale behind this 'ruse' was not discussed although the consent included the possibility of maintenance if detox was not succeeding. It meant that although, by definition, all maintenance patients had 'failed' at their initial goal, their maintenance treatment was evidence based and very likely life-saving, unlike detoxification. Further, maintenance is, or should be, a flexible treatment which can be given by GPs and community pharmacists.
http://www.mja.com.au/public/issues/179_01_070703/gib10877_fm.html
comments by Andrew Byrne ..
Dear Colleagues,
This trial of buprenorphine for heroin addiction has shown for the first time, to my knowledge, that agonist treatment can be given in primary care settings with results equivalent to those obtained in specialist clinics when patients are randomised at enrolment.
These researchers randomised 115 consenting heroin addicts who were seeking detoxification and offered them a 5 day course of buprenorphine in community practice or clinic practice. After two days without medication (days 6 and 7), they were given an option to transfer to maintenance therapy on day 8.
About 75% of patients returned at day 8, and one third of them chose to have no further drug treatment. Of the other two thirds, all but 4 chose buprenorphine maintenance (2 went onto methadone while another 2 chose naltrexone). It is to the credit of these researchers that of the 64/115 (56% of original group) who started maintenance, 40 (35%) remained in treatment at 3 months. This is a derived retention rate of 62% for continuing patients by my calculations.
There were no significant differences in any of the measures between the primary care group and the clinic group. Costs were also similar. The medication was administered in the doctors' offices for the primary care cases and at the clinic dispensary for the clinic patients during the detoxification phase (doctors are permitted to administer S8 drugs 'in the normal course of medical practice' as long as they comply with appropriate local legislative requirements for documentation, etc). For the maintenance phase, prescriptions were filled at community pharmacies where patients paid $25 per week, contrasting with the clinics which were free of charge, making the outcomes for primary care even more impressive. There must be some doubt about some of the authors' derived conclusions regarding comparative costings owing to the necessarily approximate nature of the figures between private and public sectors.
The nature of this trial was rather unusual as it offered subjects the prospect of one thing (opioid detoxification) but ended up by giving most subjects quite the opposite (opioid maintenance). The rationale behind this 'ruse' was not discussed although the consent included the possibility of maintenance if detox was not succeeding. It meant that although, by definition, all maintenance patients had 'failed' at their initial goal, their maintenance treatment was evidence based and very likely life-saving, unlike detoxification. Further, maintenance is, or should be, a flexible treatment which can be given by GPs and community pharmacists.
http://www.mja.com.au/public/issues/179_01_070703/gib10877_fm.html
comments by Andrew Byrne ..
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