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Drug Treatment for Alcoholics With Bipolar Disorder

Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism; Bipolar Disorder

Intervention: sodium valproate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official(s) and/or principal investigator(s):
Ihsan M Salloum, MD, MPH, Principal Investigator, Affiliation: University of Miami


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

Clinical Details

Official title: Efficacy of Valproate Maintenance in Bipolar Alcoholics

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in proportion of heavy drinking days

Secondary outcome: Changes in depressive and manic symptoms

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


Locations and Contacts

Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information

Starting date: October 2000
Last updated: February 24, 2009

Page last updated: August 20, 2015

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