Noeline C Latt1, Stephen Jurd, Jennie Houseman, Sonia E Wutzke. 1. Faculty of medicine, University of Sydney and Herbert Street Drug and Alcohol Clinic, Royal North Shore Hospital, St Leonards, NSW 2065, Australia. nlatt@mail.usyd.edu.au
Abstract
OBJECTIVES: To determine whether naltrexone is beneficial in the treatment of alcohol dependence in the absence of obligatory psychosocial intervention. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. SETTING: Hospital-based drug and alcohol clinics, 18 March 1998 - 22 October 1999. PATIENTS: 107 patients (mean age, 45 years) fulfilling Diagnostic and statistical manual of mental disorders (4th edition) criteria for alcohol dependence. INTERVENTIONS:Patients with alcohol dependence were randomly allocated to naltrexone (50 mg/day) or placebo for 12 weeks. They were medically assessed, reviewed and advised by one physician, and encouraged to strive for abstinence and attend counselling and/or Alcoholics Anonymous, but this was not obligatory. MAIN OUTCOME MEASURES: Relapse rate; time to first relapse; side effects. RESULTS: On an intention-to-treat basis, the Kaplan-Meier survival curve showed a clear advantage in relapse rates for naltrexone over placebo (log-rank test, chi(2)(1) = 4.15; P = 0.042). This treatment effect was most marked in the first 6 weeks of the trial. The median time to relapse was 90 days for naltrexone, compared with 42 days for placebo. In absolute numbers, 19 of 56 patients (33.9%) taking naltrexone relapsed, compared with 27 of 51 patients (52.9%) taking placebo (P = 0.047). Naltrexone was well tolerated. CONCLUSIONS: Unlike previous studies, we have shown that naltrexone with adjunctive medical advice is effective in the treatment of alcohol dependence irrespective of whether it is accompanied by psychosocial interventions.
RCT Entities:
OBJECTIVES: To determine whether naltrexone is beneficial in the treatment of alcohol dependence in the absence of obligatory psychosocial intervention. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. SETTING: Hospital-based drug and alcohol clinics, 18 March 1998 - 22 October 1999. PATIENTS: 107 patients (mean age, 45 years) fulfilling Diagnostic and statistical manual of mental disorders (4th edition) criteria for alcohol dependence. INTERVENTIONS:Patients with alcohol dependence were randomly allocated to naltrexone (50 mg/day) or placebo for 12 weeks. They were medically assessed, reviewed and advised by one physician, and encouraged to strive for abstinence and attend counselling and/or Alcoholics Anonymous, but this was not obligatory. MAIN OUTCOME MEASURES: Relapse rate; time to first relapse; side effects. RESULTS: On an intention-to-treat basis, the Kaplan-Meier survival curve showed a clear advantage in relapse rates for naltrexone over placebo (log-rank test, chi(2)(1) = 4.15; P = 0.042). This treatment effect was most marked in the first 6 weeks of the trial. The median time to relapse was 90 days for naltrexone, compared with 42 days for placebo. In absolute numbers, 19 of 56 patients (33.9%) taking naltrexone relapsed, compared with 27 of 51 patients (52.9%) taking placebo (P = 0.047). Naltrexone was well tolerated. CONCLUSIONS: Unlike previous studies, we have shown that naltrexone with adjunctive medical advice is effective in the treatment of alcohol dependence irrespective of whether it is accompanied by psychosocial interventions.
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