Full Text View
Tabular View
No Study Results Posted
Related Studies
Acamprosate vs. Placebo in Bipolar Alcoholics
This study is currently recruiting participants.
Study NCT00466661   Information provided by Medical University of South Carolina
First Received: April 25, 2007   Last Updated: November 17, 2009   History of Changes

April 25, 2007
November 17, 2009
April 2007
February 2010   (final data collection date for primary outcome measure)
Percent of days abstinent [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent of days abstinent
  • Days until relapse
  • Drinks per drinking day
  • Percent of heavy drinking days
  • Carbohydrate-deficient transferrin
  • Gamma-glutamyltransferase
  • Total alcohol consumption
Complete list of historical versions of study NCT00466661 on ClinicalTrials.gov Archive Site
  • Montgomery Asberg Depression Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Obsessive Compulsive Drinking Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Days until first drink [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Drinks per drinking day [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent heavy drinking days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent carbohydrate-deficient transferrin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Gamma-glutamyltransferase [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Drinks per week [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Montgomery Asberg Depression Rating Scale score
  • Young Mania Rating Scale score
  • Obsessive Compulsive Drinking Scale score
  • Clinical Global Impression scale score
 
Acamprosate vs. Placebo in Bipolar Alcoholics
A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.

The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Alcohol Dependence
  • Bipolar Disorder
  • Drug: Acamprosate
  • Drug: Placebo
  • Experimental: 666 mg p.o. TID
  • Placebo Comparator: Matching placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
March 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adults ages 18-65
  2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence
  3. Meet DSM-IV criteria for bipolar I or bipolar II disorder
  4. Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
  5. Must be able to remain free from alcohol for at least 3 days prior to medication initiation
  6. 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
  7. Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments

Exclusion Criteria:

  1. Individuals with a primary psychiatric disorder other than bipolar disorder
  2. Individuals with an uncontrolled neurologic condition that could confound the results of the study
  3. Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
  4. Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
  5. Concomitant use of other psychotropic medications not allowed per the protocol
  6. Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
  7. Current suicidal or homicidal risk
  8. Baseline scores of > 35 on the Montgomery Asberg Depression Rating Scale and/or > 25 on the Young Mania Rating Scale
Both
18 Years to 65 Years
No
Contact: Bryan K Tolliver, M.D., Ph.D (843) 792-5205 tollive@musc.edu
Contact: Delisa G Brown, BA (843) 792-0572
United States
 
NCT00466661
Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina
HR#16928
Medical University of South Carolina
Forest Laboratories
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
Medical University of South Carolina
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP