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Open Label Trial of Acamprosate in Bipolar Alcoholics

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00330486
First received: May 25, 2006
Last updated: September 18, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Bipolar Disorder
 Drug: Acamprosate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Alcohol use as determined by the time-line follow-back instrument

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

Enrollment: 9
Study Start Date: April 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330486

Locations
United States, South Carolina
Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Bryan K. Tolliver, M.D., Ph.D. Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Study Director: Kathleen T. Brady, M.D., Ph.D. Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00330486     History of Changes
Other Study ID Numbers: HR15882, 5 K24DA000435-08
Study First Received: May 25, 2006
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Acamprosate
Addiction
Alcoholism
Alcohol dependence
Bipolar disorder
 Depression
Impulsivity
Mania
Substance abuse

Additional relevant MeSH terms:
Alcoholism
Bipolar Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Affective Disorders, Psychotic
 Mood Disorders
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013