A randomized, multicentre, open-label, comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence
19.11.2007
Aim: To compare the effects in alcohol-dependent patients ofthree pharmacotherapies, disulfiram (DIS), naltrexone (NTX),and acamprosate (ACA), when used with a brief manual-based cognitive-behaviouralintervention. Method: We conducted a randomized, open label,multicentre naturalistic study in two phases; first, a 12-weekcontinuously 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-seekingalcohol-dependent adult outpatients. Subjects were randomized1:1:1 to receive supervised NTX, ACA or DIS, 50, 1998, or 200mg, respectively, per day, plus a brief manual-based cognitive-behaviouralintervention. The patients were met in the second and sixthweeks, and then after 3, 6, and 12 months. The primary outcomemeasures were the time (days) to first heavy drinking day (HDD),and time during the first 3 months to the first drinking dayafter medication started. Secondary variables were abstinentdays/week (0 drinks/day), average weekly alcohol intake, AlcoholUse Disorder Identification Test (AUDIT), Severity of AlcoholDependence 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 continuousmedication phase, treatment with DIS was more effective in reducingHDDs and average weekly alcohol consumption, and increasingtime to the first drink, as well as the number of abstinentdays. During the TM period, there were no significant differencesbetween the groups in time to first HDD and days to first drinking,but the abstinence days were significantly more frequent inthe DIS group than ACA and NTX. There were no differences betweenthe NTX and ACA groups in either phase of the study of drinkingoutcomes. However, SADD scores improved more in the NTX groupthan the ACA group. Conclusions: Patients allocated to ACA,NTX and DIS combined with brief manual-based cognitive behaviouralintervention significantly reduce their alcohol consumptionand report improved QL. Supervised DIS appeared superior, especiallyduring the continuous medication period, to NTX and ACA.
The article title was printed with a typographical error. Thishas been corrected now.
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