A RANDOMIZED TRIAL OF ADDING FLUOXETINE TO A NALTREXONE TREATMENT PROGRAM FOR HEROIN-ADDICTS

Aims. The purpose of the study was to assess whether fluoxetine would enhance retention in a naltrexone (NTX) treatment programme. Design. R andomized clinical trial. Setting. The clinical trial was conducted in two Drug Dependence Centres (DCs) of the Basque Country, Spain over a 1-year period. These DCs routinely used naltrexone as part of their t reatment. Participants. A total of 112 heroin addicts included in a na ltrexone treatment programme were randomly allocated to two groups of 56 patients each. Intervention. One group received 20 mg/24 h of fluox etine for the first 6 months, while the remaining 56 patients were use d as controls. No placebo teas used. Measurements. Retention rates and hazard functions were estimated. The risk difference and relative ris k were also calculated at 6 and 12 months. Findings. The survival func tions showed significantly higher retention rates in the fluoxetine gr oup than among the controls. The risk difference at both 6 months (RD6 = 0.23, CI 95% = 0.06-0.42) and 12 months (RD12 = 0.21, CI 95% = 0.09 -0.39) favoured the fluoxetine group, with a greater dropout risk at b oth times among the controls (RR6 = 1.81, CI 95% = 1.11-2.94; RR12 = 1 .46, CI 95% = 1.04 = 2.04). Conclusions. We study showed that the comb ination of fluoxetine and naltrexone produced significantly greater re tention than in patients given only naltrexone. Placebo-controlled tri als are warranted to assess how far this reflects a specific pharmacol ogical effect.