Acamprosate vs. Placebo in Bipolar Alcoholics
Condition: Alcohol Dependence; Bipolar Disorder
MeSH terms: Alcoholism; Bipolar Disorder
Intervention: Acamprosate; Placebo
Intervention description: 666 mg po TID; 2 tabs po TID
Intervention MeSH terms: Acamprosate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acamprosate; Alcoholism; Bipolar disorder; Comorbidity; Craving; Depression; GABA; Glutamate; Mania; Pharmacotherapy; Withdrawal

Summary:

      To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of
      acamprosate in individuals with alcohol dependence and bipolar disorder who are also
      receiving mood stabilizing medication. The study will assess the safety and efficacy of
      acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use
      and mood symptoms relative to placebo.

      The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and
      alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement
      in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary
      hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with
      acamprosate will have greater mood stability as compared to those treated with mood
      stabilizers alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults ages 18-65

          2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence

          3. Meet DSM-IV criteria for bipolar I or bipolar II disorder

          4. Currently on a mood stabilizing medication regimen, including the use of lithium,
             valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent FDA approved to
             treat bipolar disorder without any dosage adjustments in the past 30 days

          5. Must be able to remain free from alcohol for at least 3 days prior to medication
             initiation

          6. 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

          7. Subjects must consent to random assignment and be willing to commit to medication
             treatment and follow-up assessments

        Exclusion Criteria:

          1. Individuals with a primary psychiatric disorder other than bipolar disorder

          2. Individuals with an uncontrolled neurologic condition that could confound the results
             of the study

          3. Individuals with an uncontrolled medical condition that may adversely affect the
             conduct of this trial or jeopardize the subject's safety

          4. Participants with creatinine clearance less than or equal to half of normal value as
             indicated by chem. 7 results conducted at screening visit.

          5. Concomitant use of other psychotropic medications not allowed per the protocol

          6. Women of childbearing potential who are pregnant, lactating or refuse to use adequate
             forms of birth control

          7. Current suicidal or homicidal risk

          8. Baseline scores of > 35 on the Montgomery Asberg Depression Rating Scale and/or > 25
             on the Young Mania Rating Scale