Skip to main content
OpenTrials
Completed

NCT Number: NCT00466661

Acamprosate vs. Placebo in Bipolar Alcoholics

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Chemically-Induced Disorders Depression 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 4

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, 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

Treatment and study plan

acamprosate

Drug

666 mg po TID

Placebo

Drug

2 tabs po TID

Primary outcomes

  1. Time to First Drink (Days)

    Time frame: 8 weeks

    Number of days after randomization until consumption of first alcoholic beverage per self-report.

Secondary outcomes

  1. Percent Days Abstinent

    Time frame: 8 weeks

    Percentage of days in trial with no alcohol consumption

  2. Percent Heavy Drinking Days

    Time frame: 8 weeks

    Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)

  3. Percent Carbohydrate-deficient Transferrin

    Time frame: 8 weeks

    Measured level of validated serum alcohol biomarker

  4. Gamma-glutamyltransferase

    Time frame: 8 weeks

    Measured levels of validated serum alcohol biomarker

  5. Obsessive Compulsive Drinking Scale Score

    Time frame: 8 weeks

    Higher scores indicate worse outcome; minimum score = 0, maximum score = 40

  6. Montgomery Asberg Depression Rating Scale Score

    Time frame: 8 weeks

    MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.

  7. Young Mania Rating Scale Score

    Time frame: 8 weeks

    YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.

  8. Clinical Global Impression Scale Score

    Time frame: 8 weeks

    Higher values indicate worse outcomes; minimum value = 1, maximum value = 7

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2007
Registry last updated
Dec 14, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.