Open Label Trial of Acamprosate in Bipolar Alcoholics

Condition(s) targeted: Alcohol Dependence; Bipolar Disorder

Intervention: Acamprosate (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Affiliation: Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Kathleen T. Brady, M.D., Ph.D., Study Director, Affiliation: Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina

Overall contact:
Bryan K. Tolliver, M.D., Ph.D., Phone: (843) 792-5205, Email: tollive@musc.edu

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.

Official title: The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Alcohol use as determined by the time-line follow-back instrument

Secondary outcome: Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Bryan K. Tolliver, M.D., Ph.D., Phone: (843) 792-5205, Email: tollive@musc.edu

Institute of Psychiatry, Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Bryan K. Tolliver, M.D., Ph.D., Principal Investigator
Kathleen T. Brady, M.D., Ph.D., Principal Investigator

Starting date: April 2006
Last updated: April 25, 2007