PART I

INTRODUCTION

Chapter 1

Background, rationale and objectives of the study

1.1 Introduction

In 1995, the Dutch Minister of Welfare, Health and Cultural Affairs asked the Health Council of the Netherlands for advice about the prescription of heroin to chronic heroin addicts as an additional medical treatment for this population, and about the conditions under which this type of treatment could be regarded as good clinical practice. In the report written in response to this request, the Committee on Medical Interventions in Heroin Addicts of the Health Council concluded that the medical prescription of heroin to heroin dependent patients could have positive effects on their physical and mental condition, as well as on their social functioning and addictive behavior (Health Council of the Netherlands, 1995). According to the Council, medical treatment with heroin would be expedient if sound medical-scientific research would establish a positive balance between the beneficial and harmful effects associated with such treatment. In order to obtain the necessary information, the Health Council recommended to conduct a trial in the Netherlands, involving severely heroin dependent patients who did not respond (sufficiently) to the currently available medical interventions.
The government adopted the Health Council's conclusion, and, in accordance with the Dutch parliament, decided to prepare and conduct the proposed study (Ministry of Health, Welfare and Sports, 1995). In December 1996, the Minister of Health, Welfare and Sports installed the Central Committee on the Treatment of Heroin Addicts (CCBH), assigning this Committee the task to develop and conduct the study, and subsequently to report about the intended and unintended effects of medical treatment with heroin.
Following extensive discussions, the CCBH developed two parallel protocols for the study of the effects of the medical prescription of heroin to severe, treatment-resistant heroin addicts: one protocol for the investigation of the effectiveness of intravenously injected heroin, and one protocol for the trial involving inhaled heroin. In addition, separate study-protocols were written for the development and testing of a stable and efficient inhalable form of heroin administration. All protocols were developed in compliance with the international guidelines for Good Clinical Practice, the Dutch law, and common medical-ethical standards regulating the conduct of medical-scientific research.
The protocols were subsequently submitted to several international experts in the field of addiction research in order to obtain their feedback. In addition, views and experiences were intensively exchanged between the CCBH and several members of the research group involved in the Swiss study investigating medical heroin treatment. Lastly, extensive discussions took place with the Central Committee on Medical Ethics in the Netherlands. The results of these and other contacts were incorporated in the final version of the study-protocols (CCBH, 1997).

In August 1997, the final study-protocols were presented to the Minister of Health, Welfare and Sports. According to these protocols, a total of 750 patients would be included in the study, which would be conducted in eight treatment units situated in six Dutch cities. In September 1997, the parliament of the Netherlands approved the execution of a test period of three months, during which a total of 185 patients, of whom 50 would actually receive heroin, would be studied. Following the three month test, the study would be extended to its intended size if no unacceptable medical or public order problems would have occurred. In January 1998, the International Narcotics Control Board (INCB) of the United Nations confirmed the estimates of the amounts of heroin needed to sustain the study. In July 1998, the first treatment units opened in Amsterdam and Rotterdam, the cities selected for the test. Following a positive evaluation of the test period by the National Safety Committee (LVC) (1998), and the National Committee on Public Order and Controllability (LCB) (1998), the study was extended to its full size in the course of the year 2000, involving a total of eight treatment units in six cities (CCBH, 1999a). Table 1 provides an overview of the most important events and dates in the development of the study.

Table 1. Events and dates in the development of the study