Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
STUDY OBJECTIVES:
The primary objective of this study is to compare the safety and efficacy of acamprosate
versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or
anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or
social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate
treatment on mood and anxiety disorders.
STUDY DESIGN:
This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the
treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety
disorders. The active study phase will be 12 weeks in duration. There will be a two-week
screening period, followed by 12 weeks of study medication and a follow-up assessment at 14
weeks from randomization.
STUDY POPULATION:
A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of
alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social
anxiety will be recruited to participate in this study. Only those individuals whose
psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites
will participate in this trial.
TREATMENTS:
Eligible participants will be randomly assigned to receive either acamprosate or matching
placebo for 12 weeks.
EFFICACY ASSESSEMENTS:
The primary efficacy outcome measure will be cumulative days abstinent as measured by
self-report.