METODO, A Prospective Observational Study to Assess the Efficacy and Tolerability of Methadone in Heroin-Addicted Patients Undergoing a Methadone Maintenance Treatment: Preliminary Results at Baseline Evaluation

Abstract

METODO (methadone efficacy therapy optimization dosage on-going) is a prospective observational study to assess the efficacy and tolerability of methadone in 500 heroin-addicted patients taking a methadone maintenance treatment, enrolled through 2010 to 2011 in five Italian sites, observed over 2 years. The Opiate Dosage Adequacy Scale has been used for the evaluation of the “adequacy” of the methadone dosage and to stratify patients in adequate and not adequate groups. The treatment efficacy has been evaluated in correlation to the dosage adequacy during the visits. Moreover, patients have been evaluated according to the retention rate and duration of retention in treatment and a series of questionnaires.

RÉSUMÉ

METODO, une étude observationnelle prospective pour évaluer l'efficacité et la tolérabilité de la méthadone chez les patients héroïnomanes dépendants soumis à un traitement d'entretien à la méthadone: résultats préliminaires de l’évaluation initiale

METODO est une étude observationnelle prospective pour évaluer l'efficacité et la tolérabilité de la méthadone dans 500 patients dépendants d'héroïne prenant un traitement d'entretien à la méthadone, inscrits en 2010 et 2011 dans 5 sites - ambulatoires - italiens, observées sur 2 ans. L’échelle de l'adéquation du dosage aux opiacés a été utilisé pour l’évaluation de la «pertinence» de la posologie de la méthadone et de stratifier les patients en groupes que nous avons défini comme adéquats ou non. L'efficacité du traitement a été évaluée en corrélation avec le caractère adéquat dose pendant les visites. D'autre coté, les patients ont été évalués selon le taux de rétention et la durée de la rétention au traitement et avec une série de questionnaires.

RESUMEN

METODO, un estudio clìnico observacional para evaluar eficacia y tolerabilidad de la metadona entre los pacientes adictos a la heroìna sometidos a tratamiento de mantenimiento con metadona: resultados preliminares sobre una evaluacion inicial.

METODO es un estudio observacional prospectico que quiere evaluar eficacia y tolerabilidad de la Metadona entre 500 pacientes adictos a la heroina y sometidos a tratamiento de mantenimiento con Metadona. Los pacientes fueron alistados entre 2010 y 2011 en cinco centros italianos y han sido observados para dos años. Para una evaluacion de la idoneidad de dosificacion de la metadona y para dividir los pacientes en dos grupos (idoneos y non idoneos), fue utilizada la escala de dosificacion de los opiatos. La eficacia del tratamiento ha sido evaluada, durante las visitas, conectida con la idoneidad de dosificacion. Ademas, los pacientes han sido evaluados segùn la tasa de retencion, la duracion de la retencion durante el tratamiento y con algunos cuestionarios.

Keywords :

• heroin addiction
• methadone dosage adequacy
• methadone maintenance treatment
• Opiate Dosage Adequacy Scale (ODAS)
• QT interval

THE AUTHORS

Pietro Fausto D'Egidio received M.D. and Ph.D. in Internal Medicine, General Hematology, Allergology, and Clinical Immunology. He is the Director of the Addictions Treatment Service in Pescara (Italy) and National Executive Secretary of Federation of Drug Addiction Centres and Departments (FeDerSerD). He is currently concerned with research and implementation of instruments and methods of organization and evaluation of services for the treatment of addictions.

Emanuele Bignamini received M.D. and Ph.D. in Psychiatry. He is the Regional President (Piemonte and Valle d'Aosta) of FeDerSerd and a member of the National Executive Board. He is the Director of the Addiction Department at ASL TO2.

Enrico De Vivo received M.D. and Ph.D. in Infectious Diseases, Biochemistry and Cellular Biotechnology. He is currently a first level Medical Manager of the Addictions Department at ASL TO2, Pharmacology and Clinical Toxicology Area, where he is responsible for research and infective diseases.

Claudio Leonardi received M.D. and Ph.D. in Clinical Toxicology. He is currently the Department Director of the District Unit for the Prevention and Treatment of the Drug Addiction and Alcoholism—ASL Rome C. Leonardi is the member of the National Advisory Council of the National Department of Antidrug Policies at Presidency of the Council of Ministers Under-Secretary of State for Family, Drugs and Civil Service from 2005 to date; member of the Expert Group on Treatment and Rehabilitation, United Nations Office on Drugs and Crime (ONU); and author of more than 200 articles on national and international scientific journals. Leonardi is the President of the Italian FeDerSerD Lazio Regional Federation and Member of the Directive Council of FeDerSerD.

Maria Chiara Pieri received M.D. and Ph.D. in Anesthesia and Intensive Care, Hygiene and Preventive Medicine. She is currently responsible for medical management training at Sert Bologna, Regional President (Emilia Romagna) of FeDerSerd, and a member of the National Executive Board. She is Principal Investigator in five clinical trials actively participating with presentations and posters in national and international congresses on addiction-related topics. She has published several scientific articles on national and international journals such as Mission and Addiction.

Francisco González-Saiz received M.D. and Ph.D. in Psychiatry and a master's degree in Drug Addiction. He has been sharing research with clinical work with substance users and patients with severe mental disorders. His main research focus is the use of measurement instruments for the clinical assessment of patients with substance use disorders. He is currently the Head of the Community Mental Health Unit of Sierra de Cádiz (Jerez Hospital) at Andalusian Health Service, Spain.

Alfio Lucchini received M.D. and Ph.D. in Psychiatry. He is a psychiatrist, medical psychologist, and psychotherapist. He currently runs the Addictions Department and the Territorial Addictions Service at ASL Milano 2. Author of 22 printed books and about 200 scientific publications, he is the President of FeDerSerD, professor at the Università Milano Bicocca, and one of the major Italian experts in the field of pathological addictions.