Overview

This trial is active, not recruiting.

Conditions alcohol dependence, bipolar disorder
Treatments acamprosate, placebo
Phase phase 4
Sponsor Medical University of South Carolina
Collaborator Forest Laboratories
Start date April 2007
End date February 2010
Trial size 40 participants
Trial identifier NCT00466661, HR#16928

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
666 mg p.o. TID
acamprosate Campral
666 mg po TID
(Placebo Comparator)
Matching placebo
placebo
2 tabs po TID

Primary Outcomes

Measure
Percent of days abstinent
time frame: 8 weeks

Secondary Outcomes

Measure
Montgomery Asberg Depression Rating Scale score
time frame: 8 weeks
Young Mania Rating Scale score
time frame: 8 weeks
Obsessive Compulsive Drinking Scale score
time frame: 8 weeks
Clinical Global Impression scale score
time frame: 8 weeks
Days until first drink
time frame: 8 weeks
Drinks per drinking day
time frame: 8 weeks
Percent heavy drinking days
time frame: 8 weeks
Percent carbohydrate-deficient transferrin
time frame: 8 weeks
Gamma-glutamyltransferase
time frame: 8 weeks
Drinks per week
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
Principal investigator Bryan K Tolliver, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.