Acamprosate vs. Placebo in Bipolar Alcoholics
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/16/2018 |
| Start Date: | April 2007 |
| End Date: | February 2010 |
A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
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.
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.
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
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