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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
666 mg po TID
2 tabs po TID
Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, United States
Time to First Drink (Days)
Number of days after randomization until consumption of first alcoholic beverage per self-report.
Time frame: 8 weeks
Percent Days Abstinent
Percentage of days in trial with no alcohol consumption
Time frame: 8 weeks
Percent Heavy Drinking Days
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)
Time frame: 8 weeks
Percent Carbohydrate-deficient Transferrin
Measured level of validated serum alcohol biomarker
Time frame: 8 weeks
Gamma-glutamyltransferase
Measured levels of validated serum alcohol biomarker
Time frame: 8 weeks
Obsessive Compulsive Drinking Scale Score
Higher scores indicate worse outcome; minimum score = 0, maximum score = 40
Time frame: 8 weeks
Montgomery Asberg Depression Rating Scale Score
MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Time frame: 8 weeks
Young Mania Rating Scale Score
YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Time frame: 8 weeks
Clinical Global Impression Scale Score
Higher values indicate worse outcomes; minimum value = 1, maximum value = 7
Time frame: 8 weeks
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