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OpenTrials
Completed

NCT Number: NCT00330486

Open Label Trial of Acamprosate in Bipolar Alcoholics

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Behavior Behavior, Addictive Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Chemically-Induced Disorders Compulsive Behavior Depression Impulsive Behavior Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Psychiatry, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acamprosate

Drug

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 26, 2006
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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