Acamprosate vs. Placebo in Bipolar Alcoholics

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder; Alcohol Dependence

Treatments: Drug: Placebo; Drug: Acamprosate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00466661

HR#16928

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Acamprosate

Experimental group

Description:

666 mg p.o. TID

Treatment:

Drug: Acamprosate

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo