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Drug Treatment for Alcoholics With Bipolar Disorder

Primary Purpose

Alcoholism, Bipolar Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sodium valproate
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

sodium valproate

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in proportion of heavy drinking days
Change from baseline

Secondary Outcome Measures

Changes in depressive and manic symptoms
Changes in depressive and manic symptoms scores from baseline

Full Information

First Posted
November 2, 1999
Last Updated
January 16, 2018
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00000439
Brief Title
Drug Treatment for Alcoholics With Bipolar Disorder
Official Title
Efficacy of Valproate Maintenance in Bipolar Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sodium valproate
Arm Type
Active Comparator
Arm Description
sodium valproate was added on treatment as usual and dose monitored by blood level measurements
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator was added on treatment as usual and dose monitored by blood level measurements
Intervention Type
Drug
Intervention Name(s)
sodium valproate
Other Intervention Name(s)
Depakote, Divalproex sodium, Depacon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in proportion of heavy drinking days
Description
Change from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in depressive and manic symptoms
Description
Changes in depressive and manic symptoms scores from baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihsan M Salloum, MD, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15630071
Citation
Salloum IM, Cornelius JR, Daley DC, Kirisci L, Himmelhoch JM, Thase ME. Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study. Arch Gen Psychiatry. 2005 Jan;62(1):37-45. doi: 10.1001/archpsyc.62.1.37.
Results Reference
result

Learn more about this trial

Drug Treatment for Alcoholics With Bipolar Disorder

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