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Background: Many medications have been used for stabilizing heroin users: Methadone, Buprenorphine and LAAM. The present review focus on the prescription of heroin to heroin dependents., Objectives: To assess the efficacy and acceptability of heroin maintenance versus methadone or other substitution treatments for opioid dependence, in retaining patients in treatment; reducing the use of illicit substances and improving health and social functioning., Search Strategy: The Cochrane Central Register of Trials (CENTRAL) issue 1, 2005; MEDLINE 1966-2005, EMBASE 1980-2005 and CINAHL till 2005 (on OVID) were searched. There was no language or publication year restrictions. Many researchers were contacted for information., Selection Criteria: Randomised controlled trials of heroin (alone or combined with methadone) maintenance treatment compared with any other pharmacological treatments for heroin dependents., Data Collection and Analysis: The trials were independently assessed for inclusion and methodological quality by the reviewers. Data were extracted independently and double checked. Studies were not pooled together because of heterogeneity., Main Results: 2400 references were obtained and 20 studies were eligible, 4 met the inclusion criteria for a total of 577 patients. The studies could not be analysed cumulatively because of heterogeneity of interventions and outcomes. Retention in treatment: no groups difference was found in two studies; one study (N=96) found RR=2.82 (95% CI 1.70-4.68) favouring heroin; one study (N=235) found RR 0.79 (95%CI 0.68-0.90) favouring methadone. Relapse to illegal heroin use (self- reported): in one study people using heroin in treatment was 64% (heroin group)and 59% (methadone group); in the other study the RR of heroin use was 0.33 (95%CI 0.15-0.72) favouring heroin. Criminal offence: one study showed the potential of heroin prescription in reducing the risk of being charged RR 0.32 (95% CI 0.14-0.78). Social functioning: two studies did not show statistical difference between intervention groups, and two studies considered criminal offence and social functioning as part of a multidomain outcome measure showing improvements among those treated with heroin plus methadone over those on methadone only., Authors' Conclusions: No definitive conclusions about the overall effectiveness of heroin prescription is possible. Results favouring heroin treatment come from studies conducted in countries where easily accessible Methadone Maintenance Treatment at effective dosages is available. In those studies heroin prescription was addressed to patients who had failed previous methadone treatments. The present review contains information about ongoing trials which results will be integrated as soon as available.

Background: Dependent heroin users are characterised by the persistence of use in spite of the difficulties they experience with health, law, social achievements and personal relationships. The present review will consider maintenance treatment in which the patients enter programs of pharmacological administration tailored to achieve patient stabilisation. Many medications have been used for this purpose such as: Methadone, Buprenorphine and LAAM. The present review will focus on maintenance treatment through the prescription of heroin., Objectives: To assess the efficacy and acceptability of heroin maintenance versus methadone or other substitution treatments for opioid dependence, in retaining patients in treatment; reducing the use of illicit substances and improving health and social functioning., Search Strategy: The Cochrane Central Register of Trials (CENTRAL) issue 4, 2002; MEDLINE (on Silver Platter) 1966-2002; EMBASE (on OVID) 1980-2000 and CINAHL till 2000 were searched. There was no language or publication year restrictions. Many researchers were contacted for information., Selection Criteria: Randomised controlled trials of heroin (alone or combined with methadone) maintenance treatment compared with any other pharmacological treatments., Data Collection and Analysis: The trials were independently assessed for inclusion and methodological quality by the reviewers. Data were extracted independently and double checked. Studies were not pooled together because of heterogeneity., Main Results: 2400 references were obtained and 20 studies were eligible, 4 met the inclusion criteria for a total of 577 patients. The studies included could not be analysed cumulatively because of heterogeneity of interventions and outcomes considered. Two studies compared injected heroin to oral methadone for 1 year (270 patients) but considered different outcomes; one study compared injected heroin and methadone to oral methadone for 6 months (51 patients); and one compared inhaled heroin and methadone to oral methadone for 1 year (235 patients). Retention in treatment: in two studies there was no statistical difference between groups; one study (N=90) had a RR=2.49 (95% CI 1.51-4.10) in favour of heroin; one study (N=235) had a RR 0.79 (95%CI 0.68-0.90) in favour of methadone. Relapse to illegal heroin use, based on self report: in one study the proportion of people still using heroin were 64% in the heroin group, 59% methadone group; in the other study the RR was 0.33 (95%CI 0.15-0.72) in favour of heroin. The remaining studies did not provide the data. Criminal offence: one of the two studies which provided details about this showed the potential of heroin prescription in reducing the risk of being charged RR 0.32 (95% CI 0.14-0.78). Social functioning: the two studies reporting this outcome did not show statistical difference between intervention groups. The two most recent studies considered criminal offence and social functioning as part of a multidomain outcome measure and showed higher improvement among those treated with heroin plus methadone over those on methadone only., Reviewer's Conclusions: No definitive conclusions about the overall effectiveness of heroin prescription is possible because of non-comparability of the experimental studies available to be included in this review. Results favouring heroin treatment come from studies conducted in countries where the treatment system is comprehensive and easy accessible Methadone Maintenance Treatment at effective dosages is available. In those studies heroin prescription was addressed to patients who had failed previous methadone treatments.

Cluster randomization is often used in intervention trials, yet when individuals nested within clusters are considered as the units of analysis for outcome evaluation, it cannot be assumed that the observations are statistically independent. Observations that are not statistically independent also result when repeated measures are taken over time for the same individual. Ignoring clustered observations when performing data analysis can lead to the erroneous conclusion that the intervention under study had a statistically significant effect. Moreover, individual responses are often collected on ordinal scales; thus models for continuous or categorical data are usually not appropriate. We applied a random effect ordinal regression model to data sets from two randomized controlled intervention trials that measured graded scale non-independent responses. The first trial compared two school programmes for AIDS prevention in terms of impact (i.e., changes in the frequency of condom use). The second trial used the MOS-HIV questionnaire to measure the quality of life of new AIDS cases four times over a one-year follow-up period (only results of the role-functioning scale are reported). Regarding the first data set, the effect of the intervention was not significant, and the post-intervention frequency of condom use was mainly attributable to the pre-intervention frequency (p<0.01), with no differences among schools. Regarding the second data set, a borderline significant increase in the role-functioning scale scores was observed over the follow-up period; the results differed only slightly by intervention group; a significant (p<0.01) intra-individual correlation of 0.4 was found., (Copyright 2001 John Wiley Sons, Ltd.)

Data gathered through the Latium HIV Surveillance System were used in conjunction with a compartmental mathematical model to describe the transmission dynamics of HIV-1 in Italy. In the Latium region, as in the rest of Italy, fewer than 1 in 5 cumulative cases of AIDS are attributable to male homosexual transmission, while 55-60 per cent of the cases have been observed among intravenous drug users (IVDUs). Moreover, the number of non-drug-using heterosexual cases is increasing (14 per cent of cumulative cases). Anonymous notification of positive HIV-1 tests, mandatory in Latium since 1985, were used to produce a time series of new HIV-1 diagnoses; just over 400 new cases of infection per quarter were diagnosed from mid 1989 to mid 1990, with no evidence of increasing incidence. A minimum of 6009 and a maximum of 10,000 individuals with HIV-1 as of the end of 1989 were estimated, 80 per cent of adult cases occurring among IVDUs. The model included two main subgroups: IVDUs and non-drug-using heterosexuals, both with behavioural heterogeneities. Sharing of needles among IVDUs and heterosexual contact were considered as possible ways of transmitting HIV-1. A mathematical framework was developed to reproduce different mixing patterns within and between subgroups. A scenario analysis of the model showed incident cases of HIV-1 among IVDUs peaking early, then declining dramatically and stabilising at low values, with a stable-state prevalence higher than 0.75. Heterosexual interaction with IVDUs resulted in a significant, but non-self-sustaining, virus spread in the general population, affecting females more than males. The extent of this spread is associated with the assortativeness of the sexual mixing pattern adopted. The qualitative features of the Italian epidemic are well represented by the model, which highlights the role of IVDUs as an infection reservoir. However, the need emerges for more accurate information on the key parameters influencing the transmission dynamics of HIV-1.