Heroin
Assisted Treatment for Opiate Addicts – The Swiss Experience
Ambros
Uchtenhagen
Zürich
Epidemiology
The
heroin epidemic started in Switzerland in the early seventies. A rapid increase
led to an estimated number of 30‘000-40'000 addicts, ca. 0.5-0.8% of the total
population (Estermann 1996). This elevated prevalence is in line with a high
addiction liability in our population also for alcohol, tobacco and prescription
drugs (Uchtenhagen 1991).
Since
the start of the epidemic, the characteristics of users have changed
considerably. At first, drug use in general was associated with a strong
movement of youth unrest and opposition to established societal norms and
institutions. In the course of a learning process regarding drugs and the risks
of drug use, the majority of young people adapted their behaviour to the
perceived risks. Heroin got the image of a high-risk drug, in contrast to
cannabis. However, the less educated, coming from multi-problem families,
meeting more difficulties in the transition to a successful and satisfactory
life as adults, became more prominent among heroin users (e.g. origin from a
broken home was ten times elevated in comparison to the average). Finally,
during the eighties, the prevalence of psychiatric morbidity among heroin users
(dual diagnosis) increased.
This
development indicated a shift in motivation, from experimental and subcultural
use to what is termed self-medication use (Khantzian 1985). In this perspective,
heroin is used in order to alleviate from unpleasant sensations, fears and
memories.
Treatment
The
therapeutic response to the drug epidemic was at first initiated by NGO’s,
setting up Therapeutic Communities of the Phoenix house and Daytop models (New
York). Later on, state-run clinics and advisory centres were implemented, since
1975 offering methadone maintenance treatment. The introduction of substitution
treatment with oral methadone was a consequence of increasing numbers of addicts
who failed in drug-free treatment and to the finding that only a small fraction
of addicts was willing to accept long-term drug-free treatment in residential
settings.
During
the eighties and nineties, the treatment system became more diversified and
specialised. Outpatient treatment adapted psychotherapy to the needs of specific
addicts, such as borderline patients and other dual diagnosis patients. Systemic
therapy, especially family therapy in the case of adolescent addicts became a
regular option. Specialised programmes for detoxification were set up, using
diverse methods and settings. Residential long-term drug-free treatment
introduced new concepts, in order to meet the needs for social re-integration in
cases of severe social and educational deficits. Programmes for addicted couples
and even families were developed. Also, religious orientation, the value of
meditation techniques and similar approaches became an important issue.
Overall,
the treatment system increased the number of slots considerably : during the
period 1985-1994, residential treatment increased by the twofold,
methadone maintenance by the tenfold.
Harm
reduction measures
Following
the AIDS epidemic (again with high prevalence rates, for many years the highest
in Europe), risk reduction measures were – after controversial debates -
accepted and introduced : syringe exchange schemes, injection rooms, low
threshold day programmes. Also, experimentation with low-threshold methadone
programmes started and resulted in well-established special clinics in major
cities.
Due
to the abundant availability of drugs in the larger cities, addicts concentrated
there and so-called open drug scenes emerged. At first, they were periodically
repressed but re-emerged in different places, until they were tolerated in parks
with comparatively little negative impact for the neighbourhood. Things
deteriorated however, and the famous needle-parks in Zurich and Bern became
intolerable centres of trafficking, associated delinquency and prostitution. A
successful oppression of open drug scenes could only be realised through a
concerted action between national, cantonal (provincial) and municipal
authorities, and a combination of increased policy presence and an adequate
availability of harm reduction measures, support structures and treatment
opportunities outside of the larger cities (decentralised support and treatment.
An essential additional measure was the “repatriation” of addicts coming
from the countryside, from smaller cities and even from neighbouring countries
(they made up for ca. 80% of addicts identified in open drug scenes in Zurich).
Addicts injecting in public or otherwise identified were arrested and brought by
police to a special detention centre, transferred to somatic or psychiatric
treatment if needed, and otherwise shipped home to where they came from and
handed over to the respective authorities. This resulted not only in a reduced
influx of addicts, but also in an increased awareness of authorities that now
had to take care of their addicts. Also, understanding for prevention activities
increased.
Treatment
research
Most
of the therapeutic programmes and approaches for heroin addicts were new and of
uncertain efficacy. Outcome evaluation and guidelines how to run treatment
professionally were asked for. The resources invested into developing the
treatment system called for some evidence on the good use of such resources. The
National Fund for Scientific Research granted a large national study on outcome
in the late seventies. Cohorts from residential treatment, from methadone
clinics and from prisons were prospectively followed-up, and compared with a
representative sample from the same age group in the general population. The
study was able to evidence the positive outcome and a progressive
“normalisation” of life-styles in the treated cohorts in contrast to the
prison cohort (Uchtenhagen & Zimmer Höfler 1985). The results encouraged
not only the development of treatment programmes, but also the referral of
addicts from the Criminal Justice System to regular treatment agencies outside
of the prison walls (the prison sentence being suspended and eventually
reactivated in case of treatment failure). Referrals were at first made mainly
to residential treatment, then in increasing numbers also to outpatient
methadone maintenance programmes.
The
Federal Office of Public Health has since invested largely in treatment research
regarding drug dependence and drug abuse. The Federal Drug Policy of 1991 not
only stated the four pillars of policy (Prevention, treatment, harm reduction
measures and repression), but also the will to evaluate measures in the interest
of an evidence-based policy development. Reviews of treatment research have been
published by the Federal Office of Public Health (Rihs-Middel & Lotti 1997).
Why
heroin assisted treatment ?
In
spite of a good availability of therapeutic options, treatment refractory
addicts were identified in the open drug scenes, responsible for an essential
part of nuisance and drug-related delinquency. It was obvious that for this
group new approaches had to be developed.
The
Amsterdam study on injectable morphine (Derks 1991) and the renewed British
practice with injectable diamorphine (heroin) encouraged Swiss authorities and
experts in this situation to prepare a national study with heroin-assisted
treatment to those not responding to the existing treatment system.
Objectives
and design of the experimental project (1994-1996)
The
main objectives of Heroin-assisted
Treatment (HAT) were :
-
to
recruit addicts into HAT who were not effectively reached by other treatment
approaches
-
to
prevent premature dropping-out of HAT
-
to
reduce illegal / non prescribed substance use by HAT patients
-
to
improve health status and social integration of HAT patients (especially to
reduce delinquency)
-
to
compare the effects of injectable diamorphine (heroin), methadone and morphine
-
to
facilitate transfer of HAT patients to regular treatment programmes.
Design
:
In
order to determine outcome, the main study was set up as a longitudinal
prospective study (cohort study), complemented by randomised and double blind
sub-studies comparing injectable diamorphine, methadone and morphine.
Implementation
of the project
Target
population
According
to the objectives, the new therapeutic approach should be open to heroin addicts
who were chronically dependent (no beginners), who suffered from health and
social problems as a consequence of their addiction (no unproblematic users) and
who had without success engaged in other treatment programmes at least twice
(HAT is not to be administered if nothing else has been tried before). Only
addicts not younger than 18 years of age were targeted; younger adolescents
should whenever possible receive drug-free treatment.
Entry
criteria
The
criteria for participating in the project therefore concerned a minimal age of
20 (later 18), documented dependence duration of minimal 2 years, documented
health and/or social deficits and at least 2 previous treatments that failed.
Also, compliance with the diagnostic, therapeutic and research programme was
conditional. Persons in possession
of a driving licence were not allowed to drive and had to deposit their licence
during the entire treatment period.
Conditions for treatment
provision
HAT
is available exclusively in authorised clinics. Each individual must have a
permit to enter the programme, issued by the Federal Office of Public and by the
responsible medical officer of the Canton where treatment takes place.
Authorisation and permit can be revoked in case of non-compliance with rules.
Administration
of injectables has to be made by the patient under visual supervision of staff
in the clinics. There is no take-home policy regarding injectables. Patients who
are already intoxicated when presenting for an injection have to wait until they
are in a normal state.ealth and by the
cantonal medical officer
Patients
have to participate in the comprehensive assessment procedures and in the
treatment programme. They must be ready for research interviews and urine checks
although refusal is possible. At entry, they receive an information sheet and
have to sign a form on informed consent. They can leave the programme at any
time. They can be excluded temporarily or definitively when misbehaving and
breaking the rules.
Clinics
have to keep case histories of all patients and have to perform the necessary
clinical and laboratory tasks. They provide periodical reports to the Federal
Office of Public Health.
Logistics
and storage of narcotics are strictly regulated and checked.
Research
A
detailed research protocol was set up and accepted by the Federal Government and
by the national Ethics Committee of the Swiss Academy of Medical Sciences.
The
research protocol, the instruments and reports were prepared by an independent
research team at the Addiction Research Institute and the Institute of Social
and Preventive Medicine, both at Zurich University. Other research groups were
charged with specific studies, such as the study on changes in delinquency rates
(Institute of police science and criminology at Lausanne University) and the
economic study on costs and benefits of HAT (Health Econ Institute in Basel).
A
safety assurance group of experts followed closely the side effects and untoward
events occurring during the project and took appropriate steps if needed.
Sources
of information were face-to-face interviews by independent interviewers,
observations by clinic staff, case histories of former treatments, laboratory
findings and police data.
The
research team was guided by a national expert committee which monitored the
research process and products. World Health Organisation set up an additional
international expert committee which reviewed the protocol and instruments,
monitored the process and evaluated the final report (Ali et al.1999).
Main
results of the cohort study
An
extensive summary of the experimental project was published as a book
(Uchtenhagen et al 1999). It contains outcome
data on 1035 patients who entered HAT between 01.01.1994 and 30.06.1996.
The
feasibility of establishing Heroin
Clinics in 14 cities with mixed national/local funding, with adequate staff and
with a high degree of acceptance by authorities and the population could be
assured. Only one clinic could not be realised as it was allowed to prescribe
injectable morphine only, and not enough addicts were willing to enter this
programme.
Also,
the safety of patients and staff could
be evidenced (no fatal overdose from prescribed substances, no successful thefts
or deviation to the illegal market, few cases of violent behaviour). In contrast
to expectations, the daily dosages of diamorphine could not only be stabilised,
but were slightly reduced over time. Many patients preferred to combine
injectable diamorphine with oral methadone, in order to have more freedom to
resume school attendance or employment.
The
systematic monitoring of side effects
identified allergic reactions, sedation and epileptic seizures as the main side
effects occurring after diamorphine injection. Seizures are related to a
temporary insufficient oxygen saturation in the brain; they can be minimised by
activation of patients after injections and by adequate medication in patients
with a history of seizures. Side effects of injectable methadone were mainly
painful sensations at the injection site, while injectable morphine produced
more and more severe allergic reactions than diamorphine.
The
consumption of illegal / non-prescribed
substances while being on the
programme was reduced significantly (especially the daily use of heroin and
cocaine, to a lesser degree the regular use of Benzodiazepines). Cannabis use on
the other hand remained essentially unchanged, but without noticeable effect on
treatment outcome.
Health
status
was significantly improved. Especially a reduction of depressive episodes
and suicidal ideation, of epileptic attacks and of paranoid episodes was
registered. Also, general physical health and nutritional health (body mass
index) improved.
Regarding
social integration, it may be
mentioned that homelessness was significantly reduced, while reintegration into
the regular labour market proved to be more difficult. Most spectacular was the
reduction of criminal activities according to self-report and police data
(Killias & Rabasa 1998). Income from illegal activities was reduced
accordingly, in part replaced by welfare payments.
Retention
in treatment was
superior to what is observed in other forms of treatment (76% over a 12-month
period). 60% of discharged patients could be transferred to a regular treatment
programme within 18 months (about half of those to drug-free programmes).
The
cost-benefit analysis showed
a considerable reduction in costs for medical care and law enforcement; the
benefits per day and patient amount to the double of the daily treatment costs
in HAT (Frey et al 2000).
Main
results of the randomised and double-blind substudies
The
comparison of injectable diamorphine with injectable methadone and morphine came
to the following results (Ladewig et al 1997, Hämmig & Tschacher 2001,
Moldovanyi 2000) :
Recruitability
of
patients into the diamorphine groups was superior. The groups for methadone and
morphine did not reach the expected numbers, as many patients left after
randomisation before starting treatment.
Retention
was superior in the diamorphine groups. This was evidenced in the randomised and
in the double-blind studies. High dropout rates in the methadone and morphine
groups was mainly due to the extent and gravity of side effects.
Compliance
with
the programme, as measured by the extent of using illegal heroin and cocaine,
was superior in the diamorphine groups.
Overall,
diamorphine was found to be more acceptable and effective in terms of retention
and compliance than injectable methadone and morphine. Patients doing well on
methadone and morphine were allowed to continue, but no new patients were
offered this approach.
Follow-up
studies
A
first systematic follow-up study, covering a period of 18 months since entry,
was made in 1997. It included 237 patients who entered HAT from 1.1.94 to
31.3.1995 (Rehm et al 2001).
The
study documented highly significant reductions in somatic and psychiatric
problems (during the first 6 months of treatment already, and being stable over
the entire follow-up period). Improvements in the housing and employment
situation, also significant, took more time to occur. Contacts to the illegal
drug scene and living from illegal income were equally reduced (also during the
first 6 months stabilised since). The reduction not only in daily illegal heroin
use, but also in cocaine use was highly significant already in the first 6
months after entering treatment. 60% of discharged patients entered a regular
drug-free or methadone programme.
Additional
analysis showed that improvements in discharged patients were related to time in
treatment. Those who entered a regular programme at discharge showed better
results than those who did not. Improvements were not reversed with increasing
length of follow-up observation time.
A
special analysis concerned the progress of new blood-borne infections (HIV,
Hepatitis B and Hepatitis C) during treatment. It found that new infections
occurred, but at a low incidence rate much inferior to what is observed in
untreated injecting addicts (Steffen et al. 2001)
In
2000, a second systematic follow-up study was made (Güttinger, Gschwend et al,
submitted). It included a patient sample of n=244 (entries up to 31.3.1995) and
covered a period of 6 years. At that time, 46% of patients still were in
treatment. 48% of discharged patients had entered a regular programme. A
comparison of those still in treatment with those who were discharged showed :
-
a
significant reduction in illegal heroin, cocaine and Benzodiazepine use in both
groups
- no
reduction in cannabis use in both groups
-
a
significant reduction of homelessness in both groups
-
no
reduction in unemployment in both groups
-
a
highly significant reduction in living from illegal income and in new court
cases.
The
rate of patients who proceeded from HAT to drug-free treatment programmes
increased during the first year of treatment and slightly decreased since.
Conclusions
Heroin
addicts for whom other treatment approaches had failed, can be recruited and
retained in HAT to a satisfactory degree. Their health status and social
integration can be significantly improved. Improvements are mainly stable, also
in discharged patients. Side effects of prescribed diamorphine are comparatively
few and manageable. No fatal overdose of prescribed substances occurred up to
now. About half of discharged patients agreed to enter regular treatment
programmes.
These
results are conditioned by restrictive entry criteria, by strict rules for
running the authorised clinics and by a close monitoring of treatments by
research. Those conditions therefore have been kept when establishing HAT as a
regular treatment option by a Federal Decree.
Diamorphine
is registered under the name Diaphine as a medication for maintenance in heroin
addicts since January 2002.A new legal basis for HAT by a revision of Narcotic
Law is in preparation.
When
doing so, it is not the intention to replace other forms of treatment by HAT. On
the contrary, it is considered to a valuable supplement to the already existing
treatment system, with specific indications and specific precautions. A
treatment system with adequate accessibility and quality is therefore an
essential precondition for setting up HAT programmes.
The
WHO report (Ali et al 2000), while confirming the main findings of the Swiss
cohort study, advocated continued research efforts, especially in order to
determine the respective roles of diamorphine prescription and of concomitant
care for positive outcome. Another international comment (Bammer et al 1999)
came to a similar conclusion. The Dutch and German research projects on
heroin-assisted treatment have taken up these comments and will bring further
evidence. The Dutch project started on July 1998, and results will be known in
March 2002. The German project will start in early 2002 and has a duration of 2
years.
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