Back to resultsAcamprosate vs. Placebo in Bipolar Alcoholics
Primary Purpose
Alcohol Dependence, Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acamprosate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Acamprosate, Alcoholism, Bipolar disorder, Comorbidity, Craving, Depression, GABA, Glutamate, Mania, Pharmacotherapy, Withdrawal
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, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
- 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 creatinine 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acamprosate
Placebo
Arm Description
666 mg p.o. TID
Matching placebo
Outcomes
Primary Outcome Measures
Time to First Drink (Days)
Number of days after randomization until consumption of first alcoholic beverage per self-report.
Secondary Outcome Measures
Percent Days Abstinent
Percentage of days in trial with no alcohol consumption
Percent Heavy Drinking Days
Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)
Percent Carbohydrate-deficient Transferrin
Measured level of validated serum alcohol biomarker
Gamma-glutamyltransferase
Measured levels of validated serum alcohol biomarker
Obsessive Compulsive Drinking Scale Score
Higher scores indicate worse outcome; minimum score = 0, maximum score = 40
Montgomery Asberg Depression Rating Scale Score
MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Young Mania Rating Scale Score
YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Clinical Global Impression Scale Score
Higher values indicate worse outcomes; minimum value = 1, maximum value = 7
Full Information
NCT ID
NCT00466661
First Posted
April 25, 2007
Last Updated
December 12, 2018
Sponsor
Medical University of South Carolina
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00466661
Brief Title
Acamprosate vs. Placebo in Bipolar Alcoholics
Official Title
A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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, Alcoholism, Bipolar disorder, Comorbidity, Craving, Depression, GABA, Glutamate, Mania, Pharmacotherapy, Withdrawal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acamprosate
Arm Type
Experimental
Arm Description
666 mg p.o. TID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Intervention Description
666 mg po TID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 tabs po TID
Primary Outcome Measure Information:
Title
Time to First Drink (Days)
Description
Number of days after randomization until consumption of first alcoholic beverage per self-report.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percent Days Abstinent
Description
Percentage of days in trial with no alcohol consumption
Time Frame
8 weeks
Title
Percent Heavy Drinking Days
Description
Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)
Time Frame
8 weeks
Title
Percent Carbohydrate-deficient Transferrin
Description
Measured level of validated serum alcohol biomarker
Time Frame
8 weeks
Title
Gamma-glutamyltransferase
Description
Measured levels of validated serum alcohol biomarker
Time Frame
8 weeks
Title
Obsessive Compulsive Drinking Scale Score
Description
Higher scores indicate worse outcome; minimum score = 0, maximum score = 40
Time Frame
8 weeks
Title
Montgomery Asberg Depression Rating Scale Score
Description
MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Time Frame
8 weeks
Title
Young Mania Rating Scale Score
Description
YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.
Time Frame
8 weeks
Title
Clinical Global Impression Scale Score
Description
Higher values indicate worse outcomes; minimum value = 1, maximum value = 7
Time Frame
8 weeks
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, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
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 creatinine 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
Learn more about this trial
Acamprosate vs. Placebo in Bipolar Alcoholics
We'll reach out to this number within 24 hrs