Disulfiram implant: a double-blind placebo controlled follow-up on treatment outcome.

Seventy-six alcohol-dependent patients participated in a study of the clinical effect of implanted disulfiram (DS). The patients were randomized to a DS group (n = 40), receiving a subcutaneous abdominal implantation of 10 x 100 mg DS tablets and a placebo group (PL group) receiving an implantation of 9 x 100 mg calcium phosphate tablets together with one calcium phosphate tablet containing 1 mg DS. Both groups believed they were receiving DS. At admission there was no significant difference between the DS and PL groups with regard to demographic characteristics, psychosocial adjustment, drinking variables, medical disorders, or laboratory results. After a study period of approximately 300 days, 63 patients (33 DS; 30 PL) were assessed using a battery of tests. There was no significant difference between the groups with regard to reduction in average alcohol consumption, number of days to the first alcohol intake after implantation, or level of psychosocial function. Nevertheless, both groups reduced their ethanol consumption significantly, probably due to the psychological deterrent effect. The DS implant did result in a significantly higher incidence of wound complications. This study does not support the idea that a 1-g DS implant has any significant clinical effect different from the implant containing only 1 mg DS (placebo).

RCT Entities:   Population Interventions Outcomes