Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
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ClinicalTrials.gov Identifier: NCT00246441 |
Recruitment Status
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Completed
First Posted
: October 31, 2005
Last Update Posted
: December 2, 2016
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Sponsor:
Medical University of South Carolina
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina
Tracking Information | ||||
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First Submitted Date ICMJE | October 28, 2005 | |||
First Posted Date ICMJE | October 31, 2005 | |||
Last Update Posted Date | December 2, 2016 | |||
Study Start Date ICMJE | March 2002 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00246441 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism | |||
Official Title ICMJE | Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism | |||
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 and/or 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 mg/day (paroxetine or placebo) and will increase gradually to a maximum dose of 60 mg/day. 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 and/or alcohol use for coping will also be reduced in the paroxetine-treated group. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
42 | |||
Original Enrollment ICMJE |
50 | |||
Actual Study Completion Date | February 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00246441 | |||
Other Study ID Numbers ICMJE | NIAAARAN013379 R01AA013379 ( U.S. NIH Grant/Contract ) NIH Grant R01 AA013379 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | Medical University of South Carolina | |||
Study Sponsor ICMJE | Medical University of South Carolina | |||
Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | |||
Investigators ICMJE |
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PRS Account | Medical University of South Carolina | |||
Verification Date | November 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |