Acamprosate Was Not Effective for Treating Alcohol Dependence in a Family Medicine Setting

Acamprosate can support abstinence in alcohol-dependent patients; however, most prior research was conducted in specialty settings, and its efficacy in primary care remains uncertain. In this 12-week study, researchers randomized 100 recently detoxified alcohol-dependent adults in 2 family medicine settings to 666 mg acamprosate 3 times daily or to placebo. The age range of participants was 21–65 years; 62% were men, and 91% were white. Each arm received brief behavioral interventions for 5 sessions (30 minutes in the first session, 20 minutes in each remaining session) delivered via workbook by the family physician. The outcomes were percent days abstinent and percent heavy drinking days* assessed by validated calendar-based interviews at weeks 0, 2, 6, and 12.

• Medication adherence was high.

• Both study arms reported 21% days abstinent at week 0 and about 55% days abstinent at weeks 2, 6, and 12. Similarly, study arms did not differ in percent heavy drinking days during follow-up.

• Participants with an initial goal of abstinence did better on both outcomes than those with an initial goal of alcohol reduction, but there was no difference in the effect of abstinence by study arm.

• Diarrhea was the main adverse effect of acamprosate.

Comments:

Acamprosate was ineffective in these family medicine settings. The finding of no significant difference is not likely due to inadequate power, because the percent days abstinent in each study arm were nearly identical. Because 90% of participants were recruited through advertising, it was not clear how many had a prior relationship with the clinic or the physician who delivered the behavioral intervention, which may have affected the outcome. Acamprosate trials done in the US have been largely negative, whereas European studies have been positive; this is another negative US trial. Getting acamprosate to have efficacy in any setting in the US may have more to do with how patients undergo detoxification or with other unknown patient selection factors.

Kevin L. Kraemer, MD, MSc

Reference:

Berger L, Fisher M, Brondino M, et al. Efficacy of acamprosate for alcohol dependence in a family medicine setting in the United States: a randomized, double-blind, placebo-controlled study. Alcohol Clin Exp Res. November 7, 2012 [E-pub ahead of print]. doi: 10.1111/acer.12010