The primary objective of the study was to evaluate the beneficial and harmful effects of 12 months of maintenance treatment with oral methadone and co-prescribed heroin, compared with standard maintenance treatment with oral methadone alone. The study population consisted of chronic, treatment-resistant heroin addicts who were currently enrolled in methadone maintenance programs. The main effect of the medical co-prescription of heroin was evaluated in terms of (1) improvements in the physical and mental status of the patients, (2) improvements in their social integration and social functioning, and (3) changes in the patient's illicit drug use. The primary study question was investigated separately for the prescription of injectable and inhalable heroin.
The secondary study objectives included (a) a comparison of the effects of co-prescribed heroin given for six months and 12 months duration, (b) an evaluation of the effects of the discontinuation of co-prescribed heroin after six and 12 months of treatment with co-prescribed heroin, (c) an evaluation of the effect of co-prescribed heroin on patient satisfaction, and (d) an investigation of prognostic factors for positive treatment outcome, in order to generate hypotheses for future patient-treatment matching strategies.
In this report, the findings are presented with regard to the primary study objective, and first two secondary objectives. In subsequent reports, the last two secondary study objectives will be investigated.