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Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting
Author(s) -
Latt Noeline C,
Jurd Stephen,
Houseman Jennie,
Wutzke Sonia E
Publication year - 2002
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/j.1326-5377.2002.tb04550.x
Subject(s) - naltrexone , placebo , alcohol dependence , medicine , abstinence , narcotic antagonist , psychosocial , psychiatry , randomized controlled trial , clinical trial , psychological intervention , alcohol , antagonist , alternative medicine , biochemistry , receptor , chemistry , pathology
Objectives: To determine whether naltrexone is beneficial in the treatment of alcohol dependence in the absence of obligatory pyschosocial 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, χ 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.