Efficacy of acamprosate for alcohol dependence in a family medicine setting in
the United States: a randomized, double-blind, placebo-controlled study.
Author(s): Berger L(1), Fisher M, Brondino M, Bohn M, Gwyther R, Longo L, Beier N, Ford A,
Greco J, Garbutt JC.
Affiliation(s): Author information:
(1)Center for Addiction and Behavioral Health Research, University of
Wisconsin-Milwaukee, Milwaukee, WI, USA.
Publication date & source: 2013, Alcohol Clin Exp Res. , 37(4):668-74
BACKGROUND: Acamprosate has been found to enhance rates of complete abstinence
and to increase percent days abstinent (PDA) from alcohol relative to placebo
treatment. As most U.S. clinical trials of acamprosate have been conducted in
alcohol and other drug specialty clinics, there is a need to examine the efficacy
of acamprosate in generalist settings. This study tested the efficacy of
acamprosate versus placebo on the primary study outcome of PDA in the treatment
of alcohol-dependent patients in a family medicine setting. Secondary study
outcomes included percent heavy drinking days (%HDD) and gamma
glutamyltransferase level (normal or high).
METHODS: A randomized, double-blind, placebo-controlled, parallel group design of
acamprosate was conducted in 2 family medicine settings (North Carolina and
Wisconsin). One hundred volunteers were recruited primarily by advertisement, and
participants were assigned to 666 mg (2 pills) oral acamprosate 3 times daily
(1,998 mg/d) or matching placebo over a 12-week period. All participants
concomitantly received 5 sessions of a brief behavioral intervention from a
family/primary care physician.
RESULTS: No significant treatment effect of acamprosate was found on PDA or the
secondary outcomes. Significant treatment goal by time interaction effects was
found on PDA and %HDD. Participants who had an initial goal of abstinence versus
a reduction in alcohol use improved on average over time in PDA and had less %HDD
from baseline to the end of treatment.
CONCLUSIONS: This clinical trial did not find evidence of efficacy for
acamprosate compared to placebo among alcohol-dependent individuals recruited
primarily by advertisement as studied in a primary care setting. Drinking
outcomes significantly improved regardless of medication condition. A goal of
abstinence was significantly associated with improved drinking outcomes,
suggesting that alcohol-dependent patients with such a goal may do particularly
well with counseling in a family medicine setting.
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