Open Label Trial of Acamprosate in Bipolar Alcoholics

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Bipolar Disorder

Alcohol Dependence

Treatments

Drug: Acamprosate

Study type

Interventional

Funder types

Other

Identifiers

NCT00330486

5K24DA000435-08 (U.S. NIH Grant/Contract)

HR15882

Details and patient eligibility

About

The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.

Enrollment

9 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
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 creatine 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