Clinical trial NCT00466661: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Bipolar Disorder
Keywords: Acamprosate
Alcoholism
Bipolar disorder
Comorbidity
Craving
Depression
GABA
Glutamate
Mania
Pharmacotherapy
Withdrawal
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2007-04-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to First Drink (Days)
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent Days Abstinent
timeFrame: 8 weeks
measure: Percent Heavy Drinking Days
timeFrame: 8 weeks
measure: Percent Carbohydrate-deficient Transferrin
timeFrame: 8 weeks
measure: Gamma-glutamyltransferase
timeFrame: 8 weeks
measure: Obsessive Compulsive Drinking Scale Score
timeFrame: 8 weeks
measure: Montgomery Asberg Depression Rating Scale Score
timeFrame: 8 weeks
measure: Young Mania Rating Scale Score
timeFrame: 8 weeks
measure: Clinical Global Impression Scale Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Institute of Psychiatry, Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
name: Bryan K Tolliver, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
name: Kathleen T Brady, M.D., Ph.D.
role: STUDY_DIRECTOR
References: