Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302133
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2006-03-09
Brief Title:
Optimizing Pharmacotherapy for Bipolar Alcoholics
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Optimizing Pharmacotherapy for Bipolar Alcoholics
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence
Detailed Description:
Bipolar disorder has the highest rate of association with alcohol and other substance use disorders This complex clinical presentation is asociated with severe disabilitiesmorbidity and heightened risk for suicide There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder We propose a randomized double blind placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder All participants receive supportive psychosocial treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None