Open Label Trial of Acamprosate in Bipolar Alcoholics

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330486
• Other study ID #: HR15882
• Secondary ID: 5K24DA000435-08
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 25, 2006
• Last updated: September 18, 2008
• Start date: April 2006
• Est. completion date: June 2007

Study information

• Verified date: September 2008
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

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, 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Bipolar Disorder

Intervention

Drug:
• Acamprosate

Locations

Country	Name	City	State
United States	Institute of Psychiatry, Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use as determined by the time-line follow-back instrument
Secondary	Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale