Acamprosate vs. Placebo in Bipolar Alcoholics

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Adults ages 18-65
Meet DSM-IV criteria for current (past 90 days) alcohol dependence
Meet DSM-IV criteria for bipolar I or bipolar II disorder
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
Must be able to remain free from alcohol for at least 3 days prior to medication initiation
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
Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments

Exclusion Criteria

Individuals with a primary psychiatric disorder other than bipolar disorder
Individuals with an uncontrolled neurologic condition that could confound the results of the study
Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
Concomitant use of other psychotropic medications not allowed per the protocol
Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
Current suicidal or homicidal risk
Baseline scores of > 35 on the Montgomery Asberg Depression Rating Scale and/or > 25 on the Young Mania Rating Scale

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo
Acamprosate	Acamprosate	666 mg p.o. TID

Primary Outcome Measures

Name	Time	Method
Time to First Drink (Days)	8 weeks	Number of days after randomization until consumption of first alcoholic beverage per self-report.

Secondary Outcome Measures

Name	Time	Method
Percent Days Abstinent	8 weeks	Percentage of days in trial with no alcohol consumption
Gamma-glutamyltransferase	8 weeks	Measured levels of validated serum alcohol biomarker
Obsessive Compulsive Drinking Scale Score	8 weeks	Higher scores indicate worse outcome; minimum score = 0, maximum score = 40
Young Mania Rating Scale Score	8 weeks	YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Clinical Global Impression Scale Score	8 weeks	Higher values indicate worse outcomes; minimum value = 1, maximum value = 7
Percent Heavy Drinking Days	8 weeks	Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)
Percent Carbohydrate-deficient Transferrin	8 weeks	Measured level of validated serum alcohol biomarker
Montgomery Asberg Depression Rating Scale Score	8 weeks	MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.