Switching From Methadone to Diamorphine—2-Year Results of the German Heroin-Assisted Treatment Trial

Abstract

Background: Several international clinical studies have found diamorphine treatment for opioid-dependent patients to show significantly better effects compared with methadone maintenance treatment. Aims: This analysis of the German trial of heroin-assisted treatment investigates the effects on patients’ health and drug use after switching from 12-month methadone to 12-month diamorphine treatment under similar study conditions. Methods: For a period of 24 months, the state of health was explored using the Opiate Treatment Index (OTI) health scale and the Symptom Checklist-90-R (SCL-90-R), while drug use and social situation by an extended version of the European Addiction Severity Index (EuropASI) every 6 months. Changes in these criteria were tested for significance by repeated measures analyses. Of the 434 patients, who started the 2nd year of study treatment, 90 were methadone–diamorphine switchers, and 344 received diamorphine for 2 years. Results: In the 2nd year, the methadone–diamorphine switchers succeed in catching up with the diamorphine patients. After switching to diamorphine, significant improvements in health and use of street heroin and cocaine were achieved during 1 year of diamorphine treatment. Conclusions: The results of the course of methadone–diamorphine switchers are a methodologically independent contribution toward confirming the positive effects of diamorphine treatment for difficult-to-treat opioid-dependent patients. This study supports the hypothesis that changing from optimized methadone treatment under the conditions of the clinical trial to diamorphine treatment is associated with improvements in health and drug use behavior. The study's limitations are noted.

RÉSUMÉ

Changer de la méthadone a la diamorphine –résultats de la 2ème année de l’étude allemande sur le traitement à la héroïne

Introduction: Il à été démontrer par plusieurs études internationales, que le traitement à la héroïne est plus efficaces que le traitement à la méthadone chez des patients avec des troubles de dépendance aux opiacés. Objectif: Cette analyse de l’étude allemande sur le traitement à la héroïne examine les effets de changer d'un traitement à la méthadone pendant 12 mois à un traitement à l'héroïne pendant 12 autres mois sur la santé et l'usage des drogues. Méthode: L’état de santé était examiné pendant 24 mois par l'OTI health scale et le SCL-90-R, l'usage de drogues et la situation sociale par une version de l'EuropASI. Des changements était examiné par répétitive analyses de variances. 90 de 434 patients qui participait dans le deuxième ans de l’étude changeaient de la méthadone à la diamorphine, et 344 recevait diamorphine pendant 2 ans. Résultats: Dans le deuxième an, les changeurs de la méthadone à la héroïne arrivaient au même niveau que le patients traité à la diamorphine pendant 2 ans. Un an après avoir changé à la diamorphine, des améliorations significantes de la santé, de l'usage de héroïne additionnel et de la cocaine était obtenues. Conclusions: Les résultats des changeurs de la méthadone à la héroïne représentes une contribution indépendante à confirmer les effets positives du traitement à la diamorphine des patients avec des sévères troubles de dépendance aux opiacés. Cet étude soutien l'hypothèse, que changer d'une traitement optimisé à la méthadone à une traitement à la diamorphine sur des conditions d'une étude clinique amen des améliorations de santé e usage des drogues. Trial registration: ClinicalTrials.gov, registration number: NCT00268814.

Keywords: Traitement à la héroïne, traitement à la méthadone, diacetylmorphine, troubles de dépendance aux opiacés

RESUMEN

Cambiando Metadona por Diamorfina –Resultados de 2 años del Ensayo Alemán de Heroína

Antecedentes: Varios estudios clínicos internacionales han encontrado que el tratamiento con diamorfina para pacientes dependientes de opiáceos muestra unos efectos significativamente mejores en comparación al tratamiento de mantenimiento con metadona. Objetivos: Este análisis del Ensayo Alemán de Tratamiento Asistido con Heroína investiga los efectos sobre la salud y el consumo de drogas del cambio de tratamiento con metadona durante 12 meses a diamorfina durante 12 meses bajo condiciones de estudio similares. Métodos: Durante un período de 24 meses el estado de salud se analizó mediante la escala de salud de OTI y el SCL-90-R, el consumo de drogas y la situación social con una versión ampliada del EuropASI cada 6 meses. La significación en los cambios en estos criterios se comprobó a través de análisis de medidas repetidas. De los 434 pacientes que comenzaron el segundo año de tratamiento del estudio, 90 cambiaron entre metadona y diamorfina y 344 recibieron diamorfina durante 2 años. Resultados: En el segundo año, los pacientes que cambiaron de metadona a diamorfina consiguieron alcanzar a los pacientes de diamorfina. Después del cambio a diamorfina, consiguieron mejoras significativas en la salud y uso de heroína callejera y cocaína durante un año de tratamiento con diamorfina. Conclusiones: Los resultados del curso de los pacientes que cambiaron de diamorfina a metadona son un aporte metodológicamente independiente hacia la confirmación de los efectos positivos del tratamiento con diamorfina en pacientes dependientes de opiáceos difíciles de tratar. Este estudio apoya la hipótesis de que cambiar del tratamiento optimizado con metadona en condiciones de ensayo clínico a tratamiento diamorfina, conduce a mejoras en la salud y la conducta de consumo de drogas. Registro del ensayo: ClinicalTrials.gov, número de registro: NCT00268814.

Keywords :

• heroin-assisted treatment
• methadone maintenance treatment
• diacetylmorphine
• opiate dependence
• longitudinal study
• difficult-to-treat

THE AUTHORS

Uwe Verthein, Ph.D., is working at the Centre for Interdisciplinary Addiction Research of Hamburg University as a Senior Researcher since 1991. He is involved in the management and conduction of several addiction research projects and is responsible for data management and methods in empirical studies. Main research interests and activities are clinical trials and treatment evaluation, monitoring and documentation of addiction treatment, substitution treatment, and psychosocial interventions.

Christian Haasen, M.D., is a Senior Psychiatrist at the University Medical Centre Hamburg-Eppendorf, Hamburg, Germany, and the Director of the Centre for Interdisciplinary Addiction Research (ZIS) at the University of Hamburg. His main areas of interest are treatment and health services research for the fields of alcohol and drug dependence. He is the main Editor of the journal European Addiction Research.

Jens Reimer, M.D., has been working with marginalized patients groups (HIV-positive injection drug users) for more than a decade. His expertise is in treatment of somatic and mental comorbidity in integrated settings. Dr. Reimer is a Senior Psychiatrist at the University Medical Centre Hamburg-Eppendorf, Hamburg, Germany, and acts as Managing Director of the Centre for Interdisciplinary Addiction Research at the University of Hamburg. He is Editor-in-Chief of the journals Mental Illness and Suchttherapie, as well as Editorial Assistant of European Addiction Research and Vice President of the German Society of Addiction Medicine.

Notes

1 The reader is referred to Hill's criteria for causation, which were developed in order to help assist researchers and clinicians determine if risk factors were causes of a particular disease or outcomes or merely associated [Hill, A. B. (1965). The environment and disease: associations or causation? Proceedings of the Royal Society of Medicine, 58, 295–300.].

2 This is mainly due to the smaller size of the switchers group. Although symptoms reduction is more marked than in the 2-year diamorphine group, the T-test does not yield a significant result.