Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting.

摘要: Objectives: To determine whether naltrexone is beneficial in the treatment of alcohol dependence absence obligatory pyschosocial intervention. Design: Multicentre, randomised, double-blind, placebo-controlled trial. Setting: Hospital-based drug and clinics, 18 March 1998 - 22 October 1999. Patients: 107 patients (mean age, 45 years) fulfilling Diagnostic statistical manual mental disorders (4th edition) criteria for dependence. Interventions: Patients with were randomly allocated to (50 mg/day) or placebo 12 weeks. They medically assessed, reviewed advised by one physician, encouraged strive abstinence attend counselling and/or Alcoholics Anonymous, but this was not obligatory. Main outcome measures: Relapse rate; time first relapse; side effects. Results: On an intention-to-treat basis, Kaplan-Meier survival curve showed a clear advantage relapse rates over (log-rank test, X 2 1 = 4.15; P 0.042). This effect most marked 6 weeks The median 90 days naltrexone, compared 42 placebo. In absolute numbers, 19 56 (33.9%) taking relapsed, 27 51 (52.9%) (P= 0.047). Naltrexone well tolerated. Conclusions: Unlike previous studies, we have shown that adjunctive medical advice effective irrespective it accompanied psychosocial interventions.