Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2000-10-31
2003-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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sodium valproate
sodium valproate was added on treatment as usual and dose monitored by blood level measurements
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.
placebo
Placebo comparator was added on treatment as usual and dose monitored by blood level measurements
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Responsible Party
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Principal Investigators
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Ihsan M Salloum, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
Other Identifiers
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NIAAASAL10523
Identifier Type: -
Identifier Source: org_study_id
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