Acamprosate vs. Placebo in Bipolar Alcoholics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Medical University of South Carolina.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00466661
First received: April 25, 2007
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Alcohol Dependence
Bipolar Disorder
Drug: Acamprosate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent of days abstinent [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466661

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
Forest Laboratories
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

Responsible Party: Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00466661     History of Changes
Other Study ID Numbers: HR#16928
Study First Received: April 25, 2007
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Acamprosate
Alcoholism
Bipolar disorder
Comorbidity
Craving
Depression
GABA
Glutamate
Mania
Pharmacotherapy
Withdrawal

Additional relevant MeSH terms:
Alcoholism
Bipolar Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced 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 August 28, 2014