Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Condition: Alcohol Dependence; Major Depression; Social Anxiety Disorder; Generalized Anxiety Disorder
MeSH terms: Alcoholism; Depression; Depressive Disorder; Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Participants who meet all inclusion criteria and none of the exclusion criteria will be
      randomized to receive either acamprosate or placebo in a 1:1 ratio. Participants will be
      instructed to take (2) 333 mg tablets three times a day. Participants will be seen weekly for
      12 weeks an again 14 weeks from randomization. At each weekly visit, participants will be
      asked about substance use and possible adverse events. They will also have their vital signs
      and weight measured at each visit. Psychiatric assessments, including the MADRS,HAM-A,
      Liebowitz Social Anxiety Scale, and Hospital Anxiety and Depression Scale will be performed
      at weeks 2, 4, 8, and 12. Alcohol craving will be assessed using the Obsessive Compulsive
      Drinking Scale at baseline and monthly. A urine drug screen will also be performed monthly. A
      clinical global impressions scale will be completed for both psychiatric and alcohol abuse
      symptoms at every visit. A breath alcohol test will be performed at every visit, and a urine
      drug screen will be performed at baseline and monthly during the trial.
    

Intervention name(s): Acamprosate
Intervention type(s): Drug
Intervention description(s): 2 333mg tablets three times daily
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Mood; Anxiety; Acamprosate