Drug Treatment for Alcoholics With Bipolar Disorder

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Alcoholism; Bipolar Disorder

Treatments: Drug: sodium valproate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000439

NIAAASAL10523

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

sodium valproate

Active Comparator group

Description:

sodium valproate was added on treatment as usual and dose monitored by blood level measurements

Treatment:

Drug: sodium valproate

placebo

Placebo Comparator group

Description:

Placebo comparator was added on treatment as usual and dose monitored by blood level measurements

Treatment:

Drug: sodium valproate