Open Label Trial of Acamprosate in Bipolar Alcoholics | NCT00330486

Studies
Open Label Trial of Acamprosate in Bipolar Alcoholics

NCT00330486

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Sep 19, 2008Estimated

Enrollment

9Actual

Phase

Phase 1Phase 2

Conditions

Alcohol Dependence
Bipolar Disorder

Interventions

Acamprosate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5K24DA000435-08	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

May 25, 2006

First Submission Date that Met QC Criteria

May 25, 2006

First Posted Date

May 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2008

Last Update Posted Date

Sep 19, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Name	Type	Description	Arm Group Labels	Other Names
Acamprosate	Drug

Measure	Description	Time Frame
Alcohol use as determined by the time-line follow-back instrument

Measure	Description	Time Frame
Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale

Eligibility Module

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, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
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 creatine 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Psychiatry, Medical University of South Carolina		Charleston	South Carolina	29425	United States

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism
D001714	Bipolar Disorder
D016739	Behavior, Addictive
D003863	Depression
D007175	Impulsive Behavior
D000087122	Mania
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D013654	Taurine
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic