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Drug Treatment for Alcoholics With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00000439
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Description
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Brief Summary:
The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.

Condition or disease Intervention/treatment Phase
Alcoholism Bipolar Disorder Drug: sodium valproate Phase 2

Detailed Description:
The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in individuals with alcohol dependence and bipolar disorder, in a double-blind, placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with treatment as usual, which include lithium carbonate and individual dual recovery counseling and are randomized to either sodium valproate or placebo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Valproate Maintenance in Bipolar Alcoholics
Study Start Date : October 2000
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: sodium valproate
sodium valproate was added on treatment as usual and dose monitored by blood level measurements
 Drug: sodium valproate
subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.
Other Name: Depakote, Divalproex sodium, Depacon
Placebo Comparator: placebo
Placebo comparator was added on treatment as usual and dose monitored by blood level measurements
 Drug: sodium valproate
subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.
Other Name: Depakote, Divalproex sodium, Depacon


Outcome Measures
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Primary Outcome Measures :
  1. Change in proportion of heavy drinking days [ Time Frame: 6 months ]
    Change from baseline


Secondary Outcome Measures :
  1. Changes in depressive and manic symptoms [ Time Frame: 6 months ]
    Changes in depressive and manic symptoms scores from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets the criteria for alcohol dependence with comorbid bipolar disorder.
  • Agreement to participate in outpatient treatment.
  • Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo.
  • Stable living situation.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning.
  • Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination.
  • Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.
  • Persistent elevation of liver function enzymes indicating active liver disease.
  • Pregnancy or not using an acceptable contraceptive method.
  • Inability to read or understand study forms; agree to informed consent.
  • Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder.
  • The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000439


Locations
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United States, Pennsylvania
Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Pittsburgh
Investigators
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Principal Investigator: Ihsan M Salloum, MD, MPH University of Miami
More Information
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Publications of Results:

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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00000439    
Other Study ID Numbers: NIAAASAL10523
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alcoholism
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Valproic Acid
Anticonvulsants
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs