NCT00330486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

1.2 years

First QC Date

May 25, 2006

Last Update Submit

September 18, 2008

Conditions

Alcohol DependenceBipolar Disorder

Keywords

AcamprosateAddictionAlcoholismAlcohol dependenceBipolar disorderDepressionImpulsivityManiaSubstance abuse

Outcome Measures

Primary Outcomes (1)

  • Alcohol use as determined by the time-line follow-back instrument

Secondary Outcomes (1)

  • Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale

Interventions

AcamprosateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

AlcoholismBipolar DisorderBehavior, AddictiveDepressionImpulsive BehaviorManiaSubstance-Related Disorders

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental DisordersBipolar and Related DisordersMood DisordersCompulsive BehaviorBehaviorBehavioral SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 26, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

US(1)