Acamprosate vs. Placebo in Bipolar Alcoholics - Full Text View

Sponsor:	Medical University of South Carolina
Collaborator:	Forest Laboratories
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00466661

Purpose

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.

Condition	Intervention	Phase
Alcohol Dependence Bipolar Disorder	Drug: Acamprosate Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Bipolar Disorder Depression

Drug Information available for: Acamprosate calcium Acamprosate

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Percent of days abstinent [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Montgomery Asberg Depression Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Young Mania Rating Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Obsessive Compulsive Drinking Scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression scale score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Days until first drink [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Drinks per drinking day [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percent heavy drinking days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percent carbohydrate-deficient transferrin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Gamma-glutamyltransferase [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Drinks per week [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Acamprosate 666 mg p.o. TID	Drug: Acamprosate 666 mg po TID Other Name: Campral
Placebo Comparator: Placebo Matching placebo	Drug: Placebo 2 tabs po TID

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466661

Locations

United States, South Carolina
Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Forest Laboratories

Investigators

Principal Investigator:	Bryan K Tolliver, M.D., Ph.D.	Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Study Director:	Kathleen T Brady, M.D., Ph.D.	Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00466661 History of Changes
Other Study ID Numbers:	HR#16928
Study First Received:	April 25, 2007
Last Updated:	March 25, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Acamprosate
Alcoholism
Bipolar disorder
Comorbidity
Craving
Depression

GABA
Glutamate
Mania
Pharmacotherapy
Withdrawal

Additional relevant MeSH terms:

Alcoholism
Bipolar Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Affective Disorders, Psychotic

Mood Disorders
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012