Acamprosate vs. Placebo 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. Identifier: NCT00466661
Recruitment Status : Unknown
Verified March 2010 by Medical University of South Carolina.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2007
Last Update Posted : March 26, 2010
Forest Laboratories
Information provided by:
Medical University of South Carolina

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Bipolar Disorder Drug: Acamprosate Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
Study Start Date : April 2007
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Acamprosate
666 mg p.o. TID
Drug: Acamprosate
666 mg po TID
Other Name: Campral

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
2 tabs po TID

Primary Outcome Measures :
  1. Percent of days abstinent [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale score [ Time Frame: 8 weeks ]
  2. Young Mania Rating Scale score [ Time Frame: 8 weeks ]
  3. Obsessive Compulsive Drinking Scale score [ Time Frame: 8 weeks ]
  4. Clinical Global Impression scale score [ Time Frame: 8 weeks ]
  5. Days until first drink [ Time Frame: 8 weeks ]
  6. Drinks per drinking day [ Time Frame: 8 weeks ]
  7. Percent heavy drinking days [ Time Frame: 8 weeks ]
  8. Percent carbohydrate-deficient transferrin [ Time Frame: 8 weeks ]
  9. Gamma-glutamyltransferase [ Time Frame: 8 weeks ]
  10. Drinks per week [ Time Frame: 8 weeks ]

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

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

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 identifier (NCT number): NCT00466661

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
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

Responsible Party: Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina Identifier: NCT00466661     History of Changes
Other Study ID Numbers: HR#16928
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: March 2010

Keywords provided by Medical University of South Carolina:
Bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Deterrents