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Heroin-assisted treatment as a response to

the public health problem of opiate dependence

Injection drug use (involving the injection of illicit opiates) poses serious public health problems in many countries.
Research has indicated that injection drug users are at higher risk for morbidity in the form of HIV/AIDS and Hepatitis
B and C, and drug-related mortality, as well as increased criminal activity. Methadone maintenance treatment is the
most prominent form of pharmacotherapy treatment for illicit opiate dependence in several countries, and its
application varies internationally with respect to treatment regulations and delivery modes. In order to effectively
treat those patients who have previously been resistant to methadone maintenance treatment, several countries have
been studying and/or considering heroin-assisted treatment as a complementary form of opiate pharmacotherapy
treatment. This paper provides an overview of the prevalence of injection drug use and the opiate dependence
problem internationally, the current opiate dependence treatment landscape in several countries, and the status of
ongoing or planned heroin-assisted treatment trials in Australia, Canada and certain European countries.

Keywords: clinical trials, heroin-assisted treatment, opiate dependence, opiate pharmacotherapy treatment,
public health

ILLICIT OPIATE USE AS A PUBLIC HEALTH ISSUE 60,000–90,000 in Canada, or around 330 (US) and 290–
Illicit opiate use is a considerable public health problem 430 (Canada) per 100,000 adult population aged 15 to 64
in established market economies (EMEs). Due to the respectively.3,4 Australia has an estimated 67,000–92,000
nature of illicit drug use behaviour, exact prevalence and illicit heroin users (540–750 per 100,000 population aged
incidence estimates are difficult to obtain. However, 15 to 64), which is a higher rate than in the European
based on advanced epidemiological methods and countries (see table 1 for recent illicit opiate user popula-
monitoring techniques, it is suggested that in the majority tion estimates).5,6
of EMEs, 0.1 to 0.5% of the total population are illicit While these user population fractions appear relatively
opiate users.1 More specifically, Farrell et al.2 estimate minor, illicit opiate users have considerably higher risks
that European Union countries feature opiate-dependent for morbidity, mortality and disability than the general
populations in a range of 94 to 400 persons per 100,000 population.7 There is also empirical evidence that 1–2%
adult population aged 15 to 64, and that therefore ‘despite of illicit opiate users die per annum from drug-related
some variation, each [EU] country now has a sizable and mortality.5,8,9 In EU countries, the total number of acute
comparable long-term opiate dependent population’ drug-related deaths was estimated to be 7,419 in 1996,
following the ‘epidemic growth of heroin addiction’ in the having increased from 6,819 in 1992.10 For North
1970s and 1980s. The illicit opiate using population is America, the number of drug-related deaths is estimated
estimated to be around 600,000 in the United States and in the 4,000–5,000 range per annum;3,4 and 737 opiate-
related deaths were estimated in Australia in 1998.11
With few notable exceptions, data from most EME coun-
* B. Fischer1,2, J. Rehm1,2,3, M. Kirst2, M. Casas4, W. Hall5, M. Krausz6,
N. Metrebian7, J. Reggers8, A. Uchtenhagen3, W. van den Brink9, tries suggest that more than two-thirds of illicit opiate
J.M. van Ree9 users use their substance of choice intravenously.10 This
1 Department of Public Health Sciences, University of Toronto, Canada
goes hand in hand with the fact that an increasing pro-
2 Centre for Addiction and Mental Health, Toronto, Canada
3 Addiction Research Institute, Zürich, Switzerland portion of illicit opiate users in North America and
4 Servicio de Psiquiatria, Hospital Universitari Vall d’Hebron, Barcelona, Spain Europe are also (injection) cocaine users, prompting
5 Institute of Molecular Bioscience, University of Queensland, St. Lucia,
numerous injection episodes per day, resulting in extremely
6 Klinik für Psychiatrie und Psychotherapie, Hamburg, Germany high levels of risk for infectious disease transmission as
7 Department of Social Science & Medicine, Imperial College School of well as overdose episodes. In fact, estimates suggest that
Medicine, London, UK
in the European Union, HIV prevalence within injection
8 Department of Psychiatry, Centre Hospitalier Universitaire du Sart Tilman,
Liège, Belgium drug user (IDU) populations in different countries ranges
9 Central Committee Treatment Heroin Addicts, Utrecht, The Netherlands from 0.5–32%.10 Figures for HIV infection prevalence
Correspondence: Benedikt Fischer, PhD, Department of Public Health
among the estimated IDU population in North America
Sciences, University of Toronto, McMurrich Bldg., 109C, Toronto, ON,
M5S 1A8, Canada, tel. +416 946 5792, fax +416 260 4156, range from 10–40%.12 The proportional connection
228 e-mail: between IDU and HIV is less in Australia, where 5% of
Heroin-assisted treatment and public health

Table 1 Overview of environmental characteristics of selected planned and ongoing heroin-assisted treatment studies

Estimated Proportion
heroin of heroin
addict Pop. addicts in Status of methadone Status of Kind of study Study target
popula- in treatment maintenance and other heroin-assisted planned/ group focus/
Country tion 1,000 system treatment treatment ongoing remarks References
Australia 67,000– 18,751 20–50% 25,000 in MMT; MMT Extensive RCT: co- Standard trial Hall,
92,000 widely established feasibility research prescribed outcomes: Lynskey,
through clinics and and preparation for heroin vs. health, crime, Degenhardt
GPs; other opiate controlled heroin methadone social (1999)5;
pharmacotherapies in tx trial since 1991, alone functioning. Bammer
experimental stage but no political Full trial only (1995)6
approval after successful
Belgium under 10,204 approx. About 7,000 in MMT; Heroin trial RCT: heroin- Specific target Reggers
40,000 20% in Insufficient number of protocol exists; assisted on methadone (2001)26;
MMT, MMT spots in north of approved by treatment plus resistant and Farrell et al.
but no country (waiting lists); regional medical methadone vs. untreated (2001)2
coordinated in south wide authorities as standard
registry or availability of necessary methadone
control of methadone including condition for
MMT low threshold heroin
no decision or
timelines on
Canada 60,000– 30,301 25–30% MMT became widely Trial proposal RCT: heroin- Outcomes Fischer
90,000 in MMT available after 1995; submitted for assisted include (2001)27;
(IDU) regional differences; review for March treatment vs. attraction and Fischer and
low threshold partly 2001; proposal optimized retention Rehm
available; places in reviewed and methadone (1997)28;
abstinence treatment recommended for treatment Fischer
not clear funding by (2000)29
institutes of
Health Research;
ethical review not
yet completed in
all study sites;
2003 potential
start date
France 160,000 58,874 approx. About 10,000 in MMT Protocol for heroin RCT (three Comparison Farrell et al.
60% and 90,000 in trial submitted in arms): MMT to methadone (2001)2;
buprenorphine 1999; no decision waiting list vs. which is not Barrau,
substitution treatment; yet nor clear heroin up to 3 the standard Thirion,
regional and urban/rural timelines available times daily with alternative in Micallef et al.
differences in treatment on realization MMT vs. heroin France (2001)30;
availability; waiting lists once a day and Barbier
for MMT; additional MMT (2001)31
buprenorphine available
through GPs,
methadone in treatment
Germany 150,000 82,047 more than 40,000–45,000 MMT Heroin trial RCT: 2∗2∗2; Randomisation Krausz
33% spots; regional approved by two randomized of psychosocial (2001)32;
differences; partly government; factors (heroin treatment Kalke,
low-threshold MMT; trial started vs. MMT and conditions Verthein,
10,000 codeine in 2002 psychosocial tx) (case Raschke
substituted persons; and one factor management & (1998)33;
small number of persons self-selection motivational Farrell et al.
in buprenorphine (not reached by interviewing vs. 20012
substitution treatment; treatment psychosocial
majority of opiate system and counseling)
substitution available failures of
through GPs MMT)
Netherlan 26,000 15,698 70% in 12,500 in MMT; 4,500 Heroin trial Multi-site RCT: First results: van den
ds regular treatment in drug-free treatment; ongoing with randomized recruitment was Brink, van
users; system; low threshold available; separate protocols waiting list successful with Ree (2001)34;
24,000 50% in small scale studies on for inhalable design MMT vs. N=600 subjects van den
addicts MMT i.v. morphine, i.v. and i.v. heroin-assisted and experiences Brink,
methadone, oral administration; treatment positive Hendriks,
dextramoramide final results in including MMT van Ree
2002 (1999)35

Table continued

the reported HIV infections for 1994 were attributed to welfare benefits and illicit activities, in the form of fre-
injection drug use.13 A great number of local and national quent property crime and small-scale drug dealing, as their
epidemiological surveys also indicate that the majority of major income sources.20–24
injection drug users are Hepatitis B and Hepatitis C A recent cost of illness study on the basis of data from an
infected.2,12 In many local populations, Hepatitis B and untreated illicit opiate user cohort in Toronto (N=114),
C prevalence rates reach up to 90%,14–17 although Canada found a total social cost burden of Cdn $45,000
considerable differences exist across systems. Also, per untreated user and year, due to lost productivity,
recently in some local and regional drug use cultures (i.e. health and health care, and crime and criminal justice
Netherlands, Southern Spain), the majority (up to costs.25 Similarly, Hartwig and Pies23 tabulated the direct
80–90%) of illicit opiate users has switched from injecting and indirect social costs from illicit heroin use in
to smoking/inhaling opiates as the dominant route of Germany in 1992 at approximately US $6.5 billion, or
administration, and initial evidence suggests that this has approximately $45,000 per estimated user/year.
had some impact towards reducing related morbidity as
The Global Burden of Disease (GBD) study estimated A wide variety of treatment interventions exist for illicit
that in 1990, illicit drugs in the EMEs accounted for opiate dependence (including detoxification, residential/
28,800 deaths (=0.4% of total deaths); 717,000 years of abstinence treatments, behavioural interventions). Over
life lost (YLL) due to mortality (1.4% of total YLLs); the past few decades, oral opiate pharmacotherapy – pre-
1,598,000 years of life lost due to disability (YLD) (3.3% dominantly in the form of methadone maintenance treat-
of total YLDs); 2,315,000 disability adjusted life years ment (MMT) which is estimated to make up 90% of all
(DALY) (2.3% of total DALY burden in established currently provided opiate pharmacotherapy (except for
market economies).7 France)2 – has become established as the main treatment
Criminological estimates suggest that a considerable for illicit opiate dependence in EMEs. Current local or
share of property crime, especially in urban areas, occurs national treatment regulations and delivery models,
in the form of acquisition crime committed by regular driven by social, political and professional determinants,
illicit drug users.2,18–20 Self-report data from illicit opiate differ considerably.2,38,42 For example, in some juris-
users outside of treatment indicate that their illicit drug dictions, MMT is delivered through general practitioners
purchasing expenses often accumulate to the equivalent (GPs) or community pharmacies, while other countries
of $100–200 per day, depending on cultural and environ- rely primarily on specialized drug treatment clinics (table
mental contexts.21 Research has also indicated that the 1). Differences also exist in terms of treatment require-
majority of illicit opiate users are unemployed, and use ments, i.e. treatment eligibility, psycho-social treatment

Table 1 continued Overview of environmental characteristics of selected planned and ongoing heroin-assisted treatment studies

Estimated Proportion
heroin of heroin
addict Pop. addicts in Status of methadone Status of Kind of study Study target
popula- in treatment maintenance and other heroin-assisted planned/ group focus/
Country tion 1,000 system treatment treatment ongoing remarks References
Spain 150,000– 39,371 40–60% MMT is widely Two heroin trial Andalusia: Objective to Casas
250,000 available mainly protocols exist – injectable ‘normalize’ (2001)36;
(mostly through specialized approved by heroin-assisted treatment of Farrell et al.
IDU) outpatient clinics; plan federal authorities vs. MMT; heroin (2001)2
for pharmacy delivery Catalonia: oral addiction (like
model for MMT for methadone vs ‘diabetes’)
stable patients oral heroin
Switzerlan30,000 7,106 more than Approx. 16,000 in Heroin-assisted Cohort study: Multitude of Rehm,
d 60% MMT; 2,100 in treatment is part of results positive additional Gschwend,
abstinence-based regular opiate with respect to studies Steffen et al.
treatments; 1,100 in treatment system somatic, mental (2001)37;
heroin-assisted by governmental health; Swiss
treatment decision criminality; Methadone
other indicators Report
of social (1996)38;
integration; Dobler-
consumption Mikola et al.
Farrell et al.
United 150,000– 59,055 35,000 Oral MMT; injectable Injectable heroin Trial planned Which doctors Metrebian
Kingdom 270,000 MMT methadone and heroin available for opiate but unlikely; prescribe heroin (2001)40;
slots available for small addiction study examining to how many Metrebian et
number of patients treatment since current heroin drug users; why al. (1998)41;
1920; since 1968 prescription is treatment so Farrell et al.
only by doctors practices limited? (2001)2
with special licence underway
Heroin-assisted treatment and public health

requirements, dosing, length of treatment, and behavi- in other modes of treatment; and ii) effective in producing
oural surveillance.2,38 Research over the last few decades improved health and social outcomes.55,56 Based on the
consistently shows that for those illicit opiate users who above described constellations with regards to illicit
are successfully attracted into and retained in treatment, opiate dependence, and the successes and limitations of
methadone maintenance treatment is generally effective conventional opiate pharmacotherapy treatment, a num-
in improving health status and facilitating socio-eco- ber of Western countries (namely: Australia, Belgium,
nomic stabilization as well as reducing illicit/injection Canada, France, Germany, the Netherlands, Spain,
drug use and criminal activity.3,43,44 Switzerland, United Kingdom) have embarked on im-
However, although a number of countries have made plementing or developing scientific studies to explore the
oral methadone treatment widely available in diverse potential benefits of heroin-assisted treatment within
modalities, there is evidence that a considerable propor- their national boundaries. Although the basic context
tion of illicit opiate users could not be effectively retained and rationale for these studies is similar, the specific
or attracted into methadone treatment. Treatment study approaches, parameters, design, questions and environ-
reviews suggest that 30–70% of subjects leave methadone ments of these studies differ considerably.
treatment within the first 12–24 months,44–46 and many Table 1 provides an overview of countries with a proposal
resist methadone treatment altogether. A rather narrow for a heroin-assisted treatment study officially submitted
empirical basis suggests that these methadone treatment or to be submitted to the responsible scientific/political
‘failures’ are linked to a variety of reasons, including authorities for approval or funding. In the Netherlands,
pharmacological properties and side effects of methadone, a large multi-site clinical heroin-assisted treatment trial
route of administration, dosing and delivery charac- is just completed;35 in Germany a multi-site clinical
teristics, lack of injection and drug-related euphoria.47–51 heroin-assisted treatment trial started in 2002, and the
From a public health perspective, it is predominantly the proposal for a Canadian heroin-assisted treatment
most difficult and problematic opiate users (i.e. in terms trial has recently been reviewed and recommended for
of drug use histories and patterns, somatic and psychiatric funding by the country’s main health research funding
health status, injection risks) who cannot be attracted organization. In Switzerland and the UK, heroin-assisted
into or retained in methadone treatment. These apparent treatment is currently part of the regular treatment
constraints in the desirability and effectiveness of metha- system. The other countries listed in the table are all at
done treatment have set ‘natural limits’ for the role and various stages in the planning phase of a heroin-assisted
effectiveness of this form of treatment on a population treatment study.
level. Illustrative case studies are countries like the The UK is in a distinct situation compared to other
Netherlands, Germany, Switzerland and Australia where countries, as heroin has been allowed as regular medication
methadone treatment is most widely and diversely avail- in the treatment of opiate dependence since the 1920s,
able yet ‘only’ 50–60% of illicit opiate user populations although it is limited to a select number of specialized,
are currently in treatment.2,13 licensed doctors. A research application for a study ex-
In light of the obvious limitations of conventional metha- ploring the effectiveness of heroin-assisted treatment has
done treatment on the one hand, and the severe public been developed, but funding is unlikely. However, a study
health consequences of untreated illicit opiate use on the to examine the current practice of prescribing heroin in
other hand, much time has been invested in searching for the UK began in 2000.57,58 The policy priorities in the
effective complementary forms of opiate pharmaco- area of opiate dependence treatment in the UK seem to
therapy treatment, especially for treatment-resistant be focused on improving the efficacy of MMT at this
users. The more conventional pharmacotherapy agents point.
which are either being tested or, by now, used as standard Switzerland has completed the original PROVE cohort
medication in various local settings are Buprenorphine study56 examining the impact of heroin-assisted treat-
(France, Austria, Denmark, US, UK and Australia), ment on treatment non-responders. Results showed sub-
LAAM (Portugal, Denmark, Spain, Germany, US), slow- stantial improvements in physical and mental health
release morphine (Austria) and Dihydrocodeine status, social integration (including a reduction of drug-
(Germany, Belgium, Luxembourg).2,10,52,53 related criminal activity), as well as reductions in illicit
drug use.22,37,56 Furthermore, a cost-benefit analysis in-
HEROIN-ASSISTED TREATMENT AS A THERAPEUTIC dicated that the monetary savings due to the listed bene-
OPTION fits from heroin-assisted treatment outweigh the financial
The most controversial modality in complementary costs of this form of treatment.59 Heroin-assisted treat-
opiate pharmacotherapy treatment comes in the form of ment is now available as one, yet quantitatively limited,
heroin-assisted treatment, in which heroin is used as the opiate dependence treatment option in Switzerland,
main pharmaco-therapeutic agent.42,54,55This discussion within a wide range of treatments. Altogether, this treat-
has recently been intensified both on a scientific and ment system has expanded substantially over the past two
political level with the completion of the large-scale Swiss decades, from about 700 MMT spaces in 1979, about
heroin-assisted treatment study, 1994–1997, aiming to 10,000 in 1991, to about 18,000 treatment spaces cur-
answer the fundamental questions of whether heroin- rently. Abstinence-based treatment increased from 1,900
assisted treatment is: i) effective for users who have failed spaces in 1993 to 2,100 in 1996, and heroin-assisted 231

treatment from 250 treatment spaces in 1994 to 1,100 in In France, a protocol was submitted to health authorities
1998.60 in 1999, and is still awaiting a decision. This protocol uses
The Netherlands had a similar pattern of substantial an RCT design with three arms dividing heroin-assisted
opiate treatment expansion as that in Switzerland, treatment into two components distinguished by
although this expansion began some years earlier. The frequency of delivery (one vs up to three times a day).31
Dutch heroin-assisted treatment study was designed as a The discussion on substitution in France centres mostly
randomized controlled clinical trial (RCT) of ‘last resort’ on the role of buprenorphine vs methadone,65 and a
treatment for treatment-resistant subjects, comparing decision in support of the trial is not expected to be
co-prescribed heroin and methadone treatment with finalized soon. Finally, Spain has two protocols for
methadone treatment alone, consisting of separate ex- heroin-assisted treatment trials approved by regional
perimental ‘inhalation’ and ‘injection’ arms. The trial health authorities, and both have recently been approved
began in 1998 with two pilot sites, and then expanded to by federal authorities. One protocol’s design builds on an
six more sites in 2000 with a total of 600 trial subjects. RCT design studying injectable heroin vs MMT (Andalu-
The final results of the study were just released.61 sia), while the other protocol proposes to study oral heroin
Germany’s authorities have approved a multi-site heroin- vs oral methadone (Catalonia). The Catalonian study
assisted treatment study that began in 2002. The final would add significantly to new empirical knowledge, and
revisions of the design have been negotiated between the if successful has obvious public health relevance as the use
regulatory agency (BfArM) and the study group in Ham- of oral opiate substitution treatment would potentially
burg. All study sites have confirmed their participation. reduce the risk of viral infection.
There are two target populations in the trial (methadone
non-responders and opiate addicts currently not in treat- DISCUSSION AND CONCLUSION
ment), and the effectiveness of heroin-assisted treatment Illicit opiate dependence is a major public health problem
will be compared to that of MMT, with an additional in EMEs. Heroin-assisted treatment may help reduce this
experimental variation of psychosocial care (traditional problem by attracting new illicit opiates users into therapy
drug-counselling vs. case management and motivational as well as by offering an alternative treatment for users
therapy). who have failed in conventional treatment modes. The
In the other countries listed in table 1, the time at which Dutch, Swiss, and UK experiences have clearly shown
a systematic heroin-assisted treatment trial will com- that such treatment is feasible. Moreover, the Swiss study
mence is not yet clear. In Australia, a protocol for an RCT has shown overall effectiveness of the combination of
of heroin plus methadone vs methadone alone has been heroin and methadone pharmacotherapy and psycho-
in development since the early 1990s, based on an extens- social care, and the Dutch trial provided data on
ive feasibility research programme.6 The Australian differential effectiveness of heroin vs methadone, avail-
heroin treatment trial was approved by the Ministerial able as of spring 2002. However, basically all newly pro-
Council on Drug Strategy in 1997,13 but was subsequently posed trials attempt to re-demonstrate both feasibility and
blocked by political decision makers.62,63 At this point, effectiveness of heroin-assisted treatment in comparison
the history of the trial and its failure is the subject of to methadone treatment as the ‘gold standard’.
scientific investigation,64 but there are no signs that the Since clinical, injection heroin-assisted treatment trials
project will be revived or implemented soon. However, are very expensive,66 this replication of similar studies in
an upcoming federal election in Australia that could national contexts seems a potential waste of resources.
cause a change in government, may allow a heroin- However, different socio-cultural contexts limit the
assisted treatment trial to proceed. In Belgium, a heroin- generalizability of such trials from one country to another,
assisted treatment trial protocol was submitted to the and the controversy associated with the treatment seems
health authorities in 2000 and is now awaiting approval. to require the national reproduction of these trials for
The Belgian trial proposal is also based on an RCT model. political and symbolic reasons.42 From a public health
Canada submitted a protocol to the national Canadian point of view, it would likely be a more sensible approach
Institutes for Health Research (CIHR) in spring 2001. This to consider heroin like any other pharmaceutical agent
protocol was originally developed in the context of a for the purposes of treatment and try to answer the
multi-centre American study group named the North following questions:
American Opiate Medication Initiative (NAOMI),12 Is heroin-assisted treatment as cost-effective as metha-
and the trial is based on an RCT design with patient done treatment? Are there differences in cost-effect-
attraction and retention as main outcomes. The CIHR iveness for different subgroups of users?
has scientifically reviewed and recommended the trial for What are the differential indications for different forms
funding, and has also recently funded an interdisciplinary of opiate pharmacotherapy?67 Do we really have
opiate-dependence research programme across Canada evidence-based decision criteria which allow one to
including a small-scale heroin-assisted treatment feasibil- match patient characteristics with form of treatment?
ity study. Optimistically, the larger-scale Canadian What are the best overall treatment systems for illicit
heroin-assisted treatment trial could start in three sites opiate dependence or, as more and more patients are
(Vancouver, Toronto and Montreal) in 2003, ethics poly-drug users at treatment entry, for illicit poly-drug
232 review has been obtained for all study sites. dependence? Is heroin-assisted treatment a necessary
Heroin-assisted treatment and public health

12 Kuo I, Fischer B, Vlahov D. Consideration of a North

component in such treatment systems? Does it make American heroin-assisted trial for the treatment of
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and the Canadian Institute of Health Research (CIHR). trials research - Canada. Presented at the International Network
Conference on Heroin-assisted Treatment Satellite Meeting.
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Heroin maintenance and attraction to treatment


P rofessor Fischer and his colleagues1 offer a useful and

thoughtful overview of developments and plans for
illicit heroin and other opiates does not come voluntarily
into treatment either with prevailing forms of opiate
heroin-assisted treatment studies in a total of NINE maintenance or in various ‘drug-free’ treatment regimes,
countries. The practical problem from which all the trials even when the thresholds for entry to these treatment
start is that some part of the population of regular users of modalities are lowered. As Fischer et al. note, in France
the prevailing form of opiate maintenance is with bupre-
norphine; elsewhere, it is with methadone.
* Correspondence: Dr. R. Room, Centre for Social Research on Alcohol and
Drugs - SoRad, Stockholm University, Sveaplan, S 106 91 Stockholm, Sweden, The proposition that heroin users should be in treatment
234 fax +46 8 674 7686, e-mail: rests on a variety of concerns and assumptions: a socio-