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Abstract Background In Italy, a large cohort study (VEdeTTE1) was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2) was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%). Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78%) but lower for cocaine (42.3%), highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the pilot phase underline the importance of the pilot phase when planning a follow-up study.

Background: Gender differences strongly affect heroin addiction, from risk factors to patterns of consumption, access to treatments, and outcomes. Objectives: To investigate gender differences in the VEdeTTE cohort of heroin addicts. Methods: VEdeTTE is a cohort of 10,454 heroin users enrolled between 1998 and 2001 in 115 public drug treatment centres in Italy. Clinical and personal information were collected at intake through a structured interview. Treatments were recorded using a standardized form. Gender differences were explored with regard to characteristics at intake, treatments, and retention in methadone maintenance and therapeutic community. Cox Proportional models were carried out to identify risk factors for treatment abandon. Results: Compared with men, at their first access to treatment women with drug addiction were younger, more frequently married, legally separated, divorced or widow, unemployed though better educated, HIV+; more frequently they lived with their partner and sons. They reported a higher use of sedatives, but a lower use of alcohol; more frequently they had psychiatric comorbidity, including depression, self-injuries, and suicide attempts. Psychotherapy was more frequently prescribed to women, pharmacological treatments to men. Methadone maintenance was less frequently abandoned by women. Drug abuse severity factors predicted abandon of methadone among women. High methadone doses and the combination with psychotherapy improved treatment retention in both genders. Low education level and severity factors among women and young age among men predicted abandon of therapeutic community. Conclusions: Gender differences in the VEdeTTE cohort suggest the need of a gender sensitive approach to improve treatment outcomes among heroin addicts. [ABSTRACT FROM AUTHOR]

The aim of this study was to provide a methodological overview of the study design of the national evaluation large-scale study VEdeTTE and a description of the VEdeTTE study population and to compare enrollments with refusals and the study population with the overall clients at the National Health System (NHS) treatment centers. VEdeTTE is a longitudinal study of heroin addicts recruited in 115 NHS treatment centers in Italy, 1998–2001; 11,903 people were enrolled, 3876 refused to participate; data were analysed on 10,454. Information from refusals was compared to enrollments. The characteristics of the cohort were compared to those of all patients treated in 1999 in Italy. Refusals had a lower educational level and less regular occupational status than those enrolled. Fourteen percent of enrolled patients were women; heroin users in the VEdeTTE study were older than patients attending all NHS treatment centers in Italy; incident cases were less represented. The majority of participants had more than 8 years of education, 33.5% were regularly employed, and only 2% did not have a fixed address. Injectors were 72.3%; 40.6% had a previous overdose, and 14.3% had been imprisoned for life; 15.7% shared injection equipment during the previous 6 months. The proportion of participants reporting heroin use approximately halved from the beginning of the current treatment to the time of the interview. The VEdeTTE study is the biggest cohort of heroin addicts attending treatment centers in Europe. The Italian heroin-addicted population under treatment seems to have low level of education but good social integration. Compared with men, women show a higher severity. Participants show a beneficial effect of treatment.*Scientific Committee: P Burroni, M Davoli, G Nicoletti., CA Perucci, G Renga National Coordination Group: L Amato, AM Bargagli, C Carobene, F Cipriani, L Cuomo, R Diecidue, S Della Bona, F Faggiano, B Grande, R Lovaste, N Magliocchetti, C Martini, F Mathis, L Montina, PP Pani, RM Pavarin, G Piras, R Sbrana, P Schifano, G Salamina, A Scarmozzino, S Scondotto, P Sgarzini, C Sorio, M Triassi, E Versino, G Villani. [ABSTRACT FROM AUTHOR]