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Open Label Trial of Acamprosate in Bipolar Alcoholics

Primary Purpose

Alcohol Dependence, Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acamprosate
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Acamprosate, Addiction, Alcoholism, Alcohol dependence, Bipolar disorder, Depression, Impulsivity, Mania, Substance abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Psychiatry, Medical University of South Carolina

Outcomes

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

Full Information

First Posted
May 25, 2006
Last Updated
September 18, 2008
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00330486
Brief Title
Open Label Trial of Acamprosate in Bipolar Alcoholics
Official Title
The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Bipolar Disorder
Keywords
Acamprosate, Addiction, Alcoholism, Alcohol dependence, Bipolar disorder, Depression, Impulsivity, Mania, Substance abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Acamprosate
Primary Outcome Measure Information:
Title
Alcohol use as determined by the time-line follow-back instrument
Secondary Outcome Measure Information:
Title
Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan K. Tolliver, M.D., Ph.D.
Organizational Affiliation
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen T. Brady, M.D., Ph.D.
Organizational Affiliation
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Psychiatry, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Open Label Trial of Acamprosate in Bipolar Alcoholics

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