Alcohol and Alcoholism Advance Access first published online on October 27, 2007
This version published online on November 16, 2007
Alcohol and Alcoholism, doi:10.1093/alcalc/agm136
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A randomized, multicentre, open-label, comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence
1 University of Turku and Turku Health Centre
2 National Public Health Institute, Department of Mental Health and Alcohol Research, Helsinki
3 Research Unit of Substance Abuse Medicine, Helsinki University
4 Department of Sociology and Social Psychology, University of Tampere, Finland
5 Medikalla Oy, Medfiles, Turku, Finland
* Author to whom correspondence should be addressed at: National Public Health Institute, Department of Mental Health and Alcohol Research, 00251 Helsinki, Finland. Tel: +358-9-47448123; Fax: +358-9-47448133; E-mail: hannu.alho{at}ktl.fi
Received 5 April 2007; first review notified 21 May 2007; in revised form 15 August 2007; accepted 23 August 2007
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Abstract |
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Aim: To compare the effects in alcohol-dependent patients of three pharmacotherapies, disulfiram (DIS), naltrexone (NTX), and acamprosate (ACA), when used with a brief manual-based cognitive-behavioural intervention. Method: We conducted a randomized, open label, multicentre naturalistic study in two phases; first, a 12-week continuously supervised medication, followed by targeted medication (TM) up to 52 weeks in addition to a 67-week follow-up period; altogether 119 weeks (2.5 years), in 243 voluntary treatment-seeking alcohol-dependent adult outpatients. Subjects were randomized 1:1:1 to receive supervised NTX, ACA or DIS, 50, 1998, or 200 mg, respectively, per day, plus a brief manual-based cognitive-behavioural intervention. The patients were met in the second and sixth weeks, and then after 3, 6, and 12 months. The primary outcome measures were the time (days) to first heavy drinking day (HDD), and time during the first 3 months to the first drinking day after medication started. Secondary variables were abstinent days/week (0 drinks/day), average weekly alcohol intake, Alcohol Use Disorder Identification Test (AUDIT), Severity of Alcohol Dependence Data (SADD), and quality of life (QL) measures. Results: All three study groups showed marked reduction in drinking, from baseline to the end of the study. During the continuous medication phase, treatment with DIS was more effective in reducing HDDs and average weekly alcohol consumption, and increasing time to the first drink, as well as the number of abstinent days. During the TM period, there were no significant differences between the groups in time to first HDD and days to first drinking, but the abstinence days were significantly more frequent in the DIS group than ACA and NTX. There were no differences between the NTX and ACA groups in either phase of the study of drinking outcomes. However, SADD scores improved more in the NTX group than the ACA group. Conclusions: Patients allocated to ACA, NTX and DIS combined with brief manual-based cognitive behavioural intervention significantly reduce their alcohol consumption and report improved QL. Supervised DIS appeared superior, especially during the continuous medication period, to NTX and ACA.
The article title was printed with a typographical error. This has been corrected now.