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Open Label Trial of Acamprosate in Bipolar Alcoholics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330486
Recruitment Status : Completed
First Posted : May 26, 2006
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Medical University of South Carolina

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Bipolar Disorder Drug: Acamprosate Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder
Study Start Date : April 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Alcohol use as determined by the time-line follow-back instrument

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330486


Locations
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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
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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
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ClinicalTrials.gov Identifier: NCT00330486    
Other Study ID Numbers: HR15882
5K24DA000435-08 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
Keywords provided by Medical University of South Carolina:
Acamprosate
Addiction
Alcoholism
Alcohol dependence
Bipolar disorder
 Depression
Impulsivity
Mania
Substance abuse
Additional relevant MeSH terms:
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Alcoholism
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Alcohol-Related Disorders
 Substance-Related Disorders
Chemically-Induced Disorders
Acamprosate
Alcohol Deterrents