Acamprosate vs. Placebo in Bipolar Alcoholics

Bipolar Disorder Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466661
• Other study ID #: HR#16928
• Status: Completed
• Phase: Phase 4
• Start date: April 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Bipolar Disorder

Intervention

Drug:
• Acamprosate
666 mg po TID
• Placebo
2 tabs po TID

Locations

Country	Name	City	State
United States	Institute of Psychiatry, Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Drink (Days)	Number of days after randomization until consumption of first alcoholic beverage per self-report.	8 weeks
Secondary	Percent Days Abstinent	Percentage of days in trial with no alcohol consumption	8 weeks
Secondary	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)	8 weeks
Secondary	Percent Carbohydrate-deficient Transferrin	Measured level of validated serum alcohol biomarker	8 weeks
Secondary	Gamma-glutamyltransferase	Measured levels of validated serum alcohol biomarker	8 weeks
Secondary	Obsessive Compulsive Drinking Scale Score	Higher scores indicate worse outcome; minimum score = 0, maximum score = 40	8 weeks
Secondary	Montgomery Asberg Depression Rating Scale Score	MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.	8 weeks
Secondary	Young Mania Rating Scale Score	YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.	8 weeks
Secondary	Clinical Global Impression Scale Score	Higher values indicate worse outcomes; minimum value = 1, maximum value = 7	8 weeks