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
Intervention: Acamprosate
Intervention description: 2 333mg tablets three times daily
Intervention MeSH terms: Acamprosate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Alcoholism; Mood; Anxiety; Acamprosate

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults ages 18-60

          2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence

          3. Must identify alcohol as the primary substance of abuse

          4. Meet DSM-IV criteria for a current major depressive episode, GAD and/or social anxiety
             disorder

          5. Have a stable psychiatric condition, as evidenced by a baseline CGI change score of 4
             or below between the time of initial screening and the baseline visit, and if
             receiving psychotropic medication, must have a stable dose of medication for at least
             one month prior to baseline.

          6. Must have a negative urine drug screen at the baseline visit; UDS may be repeated no
             more that twice to obtain an negative UDS

          7. May be receiving medication treatment for anxiety/mood disorder as long as the dosage
             has been stable for 4 weeks prior to randomization.

          8. May be engaged in psychosocial treatment for alcohol dependence or for mood/anxiety
             disorders.

          9. Must abstain from alcohol for at least 3 consecutive days but no more than 21 days
             prior to medication initiation

         10. Subjects must be able to adequately provide informed consent and function at an
             intellectual level sufficient to allow the accurate completion of all assessment
             instruments

         11. Subjects must consent to random assignment, be willing to commit to medication
             treatment and follow-up assessments

         12. CIWA-Ar scale is 8 or less at the baseline visit

        Exclusion Criteria:

          1. Individuals with a primary psychotic disorder or bipolar disorder

          2. Individuals who meet DSM-IV criteria for current (past 90 days) dependence on
             substances other than alcohol, caffeine or nicotine

          3. Individuals with an uncontrolled neurologic condition that could confound the results
             of the study

          4. Individuals with an uncontrolled medical condition that may adversely affect the
             conduct of this trial or jeopardize the subject's safety

          5. Regular use of benzodiazepines for the treatment of psychiatric symptoms (as defined
             as more than 12 times in the month prior to the screening visit)

          6. Individuals receiving pharmacotherapy (e.g. disulfiram or naltrexone) for prevention
             of alcohol relapse

          7. Women of childbearing potential who are lactating or refuse to use adequate forms of
             birth control

          8. Current suicidal or homicidal risk