Conditions: Alcohol Dependence Bipolar Disorder
Keywords: Acamprosate Alcoholism Bipolar disorder Comorbidity Craving Depression GABA Glutamate Mania Pharmacotherapy Withdrawal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 666 mg p.o. TID arm 2: Matching placebo

Interventions: intervention 1: Acamprosate intervention 2: Placebo
Intervention descriptions: intervention 1: 666 mg po TID intervention 2: 2 tabs po TID

Protocol document: