Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246441
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2005-10-28
Brief Title:
Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Status:
COMPLETED
Status Verified Date:
2018-09
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 the study is to determine whether an SSRI paroxetine improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder
Detailed Description:
Social anxiety disorder also known as social phobia is an Axis I anxiety disorder characterized by intense fear and avoidance of social or performance situations in which one might be scrutinized Its onset is typically in the early teen years It is the third most common mental disorder in the United States exceeded in prevalence only by depression and alcoholism Approximately 20 of the individuals with social anxiety disorder have alcohol problems Anecdotal and empirical evidence suggests that alcohol is used by some socially anxious individuals to self-medicate anxiety symptoms a practice that could lead to alcohol abuse andor dependence The proposed project further explores the self-medication hypothesis through the use of a double-blind randomized placebo-controlled clinical trial Paroxetine a selective serotonin reuptake inhibitor is the drug to be used in the study Individuals who drink alcohol to cope with social anxiety symptoms and who meet DSM-IV criteria for the dual-diagnoses of social anxiety disorder and alcohol use disorders will be enrolled in the trial All individuals will be seeking treatment for social anxiety disorder The treatment phase will last 16 weeks Dosing will start at 20 mgday paroxetine or placebo and will increase gradually to a maximum dose of 60 mgday Each week during treatment and at the end of the trial assessments will be made with standard instruments to determine the effect of paroxetine versus placebo on social anxiety severity alcohol use and more specifically the intentional use of alcohol to cope with social anxiety symptoms Additionally 6 month and 12 month follow-up interviews will be conducted The overarching hypothesis is that because paroxetine will improve social anxiety severity alcohol use andor alcohol use for coping will also be reduced in the paroxetine-treated group
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA013379 | NIH | None | httpsreporternihgovquickSearchR01AA013379 |