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FINAL REPORT OF THE RESEARCH REPRESENTATIVES
Ambros Uchtenhagen, Felix Gutzwiller and Anja Dobler-Mikola (Eds.)
SUMMARY OF THE SYNTHESIS REPORT
Summary of the synthesis report
The Medical Prescription of Narcotics Programme (PROVE) was designed according to scientific tenets and criteria. A detailed research protocol was drawn up to govern the three year collection of data for analysis. It also describes the methods and times of the data collection as well as the rules governing data transfer and data protection. Data collection began on 1 January 1994 and ended on 31 December 1996.
The objectives of the study concern the effects of the prescribed narcotics: the effects on the health, social integration and dependent behaviour of the research participants; the suitability of this treatment for heroin dependents whose previous therapy had been unsuccessful; and the effectiveness of this treatment compared with that of other therapies currently available.
The general conditions for the conduct of the programme are described in the programme's research plan of 1 November 1993, based on the Swiss government decree of 21 October 1992. They set out the admission criteria for patients, the modalities of treatment and safety regulations. The admission criteria stipulated a minimum age of 20 years, a history of heroin dependency of at least 2 years, and participation in other treatments had to have failed on several occasions. An indication of the adverse affects of drug use on health and/or social relations also had to be present. The injections of prescribed narcotics had to be given under supervision and injectable narcotics could not be taken home. The treatment had to involve the provision of psychosocial care as well as the prescription of narcotics.
In accordance with the government decree, the narcotics to be tested in the programme were morphine, methadone and heroin for intravenous and oral use. In addition, use of the cigarette form of heroin was examined, and a pilot study was conducted based on the use of cocaine cigarettes.
The research issues which were to be analysed, therefore, span a wide range of topics relating to the pharmacology and toxicology of the prescribed substances; the participants' state of health lifestyle and dependent behaviour; the practicability of the study and its economic viability.
Research plan and organisation
A research plan governing the distribution of the different narcotics amongst the patients was drawn up to deal with these issues. Two double blind studies (the prescribed substance is not known to either the patient or the therapist), three randomised studies (treatment is allocated by randomisation) and eleven studies with individual indications (treatment is allocated after discussion with the patient) were set up. The feasibility of each was tested on three occasions in a methadone outpatient clinic and once in a penal institution. One treatment centre was allocated the prescription of intravenous and oral methadone only. On the basis of initial treatment findings, the original plan for the distribution of treatment places was modified; this, however, did not necessitate any amendments to the research protocol itself. A second series of additional treatment centres was approved in order to increase the scope of the research issues.
A total of 18 treatment centres were approved; one was in a penal institution, the others were all outpatient clinics. They were located in Basel, Berne, Biel, Fribourg, Geneva, Horgen, Lucerne, Olten, St Gallen, Solothurn, Thun, Wetzikon, Winterthur, Zug and Zurich. One application was withdrawn, one refused, and one approved treatment centre was not, in the event, set up.
In view of the large number of treatment centres involved and the range of research issues to be addressed, a clear organisation of the research, including uniform rules about powers and responsibilities as well as the flow of data, was needed. A particularly rigorous audit of the programme's research procedures was also required. An independent research team were mandated the tasks of devising the research protocol, data collection procedure and analysis, and the write-up of reports. Even before the start of the study, the programme's research protocol and research plan had been submitted to the supraregional Ethics Committee of the Swiss Academy of Medical Sciences for approval. Similarly each individual treatment centre had obtained the prior approval for its project from a regional or local ethics committee. The Federal Data Protection Officer checked that the relevant provisions were observed. In addition, a national specialist group was established to oversee and
assess the activities of the research team. An additional specialist group (the Safety Assurance Group) was responsible for checking and analysing in detail any side-effects of the prescribed substances.
At the request of the INCB (International Narcotics Control Board), an international specialist group was appointed by the World Health Organisation to appraise the overall research programme and results.
Overview of research studies and data sources
This summary report incorporates the results of a series of studies mentioned below.
The main study was primarily focused on the participants and their characteristics on admission, during and on leaving treatment or on switching to another treatment programme. The information was derived from periodic interviews with the patients, conducted by specially trained interviewers. It also includes the daily treatment data on all prescribed narcotics (recorded electronically at the treatment centres). In addition, the main study examines the organisation of the treatment centres, narcotics dispensation, the professional background of the staff and the problems which arose during treatment. This information was obtained from periodic interviews with project managers.
Special medical studies examined trials carried out according to specific methodological designs (double-blind and randomised studies); side effects of the prescribed substances; pregnancies which occurred during treatment; deaths, the pharmacological properties of the heroin injected and the trial of non-injectable heroin products. The data were collected and analysed according to the terms outlined in the relevant research protocols.
Special social science studies considered the changes in criminal behaviour, the incidence of offences and of convictions. For this, information from police records and the central criminal register were extracted and compared with information obtained from the patient. Another special study examined the prison-based heroin-by-prescription project.
Special economic studies were commissioned to determine, firstly, the costs arising from treatment and, secondly, the economic benefit of treatment. Additional data were collected for these studies.
Comparison of treatment results are based on systematically recorded reference data from abstinence-based in-patient treatment institutions in Switzerland and from methadone substitution treatments in the canton of Zurich. This has enabled a comparative analysis of the findings after at least one year's treatment. The randomised study in Geneva provides the additional data needed to compare the participants' treatment results with those from other treatment programmes. In addition, a comparative study is being carried out for patients who have recently entered selected methadone maintenance clinics.
The analysis of the overall programme is based on the data of the 1,146 patients admitted to the programme who effectively started treatment. For such cases where all admission data were recorded (n=1,035), 2 cohorts were formed (A admitted before the extension and 8 admitted after the extension of the study) in order to determine any differences between the two. By the end of 1996, 350 patients had dropped out of the study. Electronically recorded data on 403,402 treatment days were included in the analysis. The in-treatment study was based on the changes observed during 6, 12 and 18 months of treatment. The permanence of such changes, however, can only be ascertained after a longer period of time.
For the special studies, the analysis was based on data drawn from various samples, the size of which varied according to the characteristics of the study (e.g. according to the observation period and the prescribed substance). The smallest-sized samples were the pharmacological pilot studies (in accordance with their governing guidelines).
The summary of results below refers to the substance-related, patient related and projectrelated research issues.
Recruitment of patients, retention rate (the duration of continuing participation) and compliance (adherence to the treatment instructions) were better with the prescription of injectable heroin than with that of injectable morphine and methadone.
Heroin cigarettes are relatively ineffective (up to 90% of the heroin is destroyed) and may be replaced by other non-injectable forms (for example, slow-release tablets).
This summarises the extent to which the designated target group of heroin dependents could effectively be reached, what changes occurred in their state of health during treatment, how illicit drug use and social integration among patients in the programme developed, and what changes were observed in criminal behaviour.
Development of the state of health
In some cases, the improvement in the participants' health and social situation referred to above occurred soon after the beginning of treatment, but in others, not until after several months of treatment. The extent to which early discontinuation of treatment can be avoided therefore plays a major role. The retention rate in the study, 89% over a period of 6 months and 69% over a period of 18 months, proved to be above average compared with other treatment programmes for heroin dependents.
An analysis of the drop outs shows:
As far as the organisation and operation of the treatment centres is concerned, the following remarks may be made:
Initially, the main problems lay in recruiting patients in some cases as well as in financing and in organisational problems in many.
Heroin prescription in methadone outpatient clinics
In the eventuality of the possible continuation of heroin-assisted treatment, we examined to what extent this form of treatment Could be given in the same institution providing methadone substitution treatment,. The findings from three treatment centres showed that the accompanying problems could be overcome and that prescription-based heroin treatment is completely feasible in the context of polyvalent outpatient clinics.
Heroin prescription in prison
The pilot study of heroin prescription in a prison environment showed that this procedure required changes (in its operation and in the attitude of staff), but that the positive findings increasingly took precedence. Furthermore, it was noted that good collaboration with outpatient treatment centres could be readily established for the follow-up treatment of discharged inmates.
Costs and benefits
A detailed examination of the costs arising in the outpatient treatment centres showed average total costs per patient day of Fr. 51.---, compared with revenue of on average Fr. 35.--- per patient day (revenue includes contributions to costs by patients, and contributions from health insurance funds and the public purse).
On the basis of these results, the report comes to the following conclusions and recommendations:
The continuation of heroin-assisted treatment can be recommended for the indications described in this research and as long as the general organisational and operational conditions set out in the research protocol are established
If the programme is continued. the unresolved questions and problems mentioned in the report should be further examined and elucidated through scientific research. The treatment itself should be appropriately monitored. documented and evaluated.
It is apparent from these conclusions that a continuation of heroin assisted treatment can be recommended for the group targeted by this programme. provided that it is administered in suitably equipped and supervised outpatient clinics which meet the general conditions and criteria as described above.