NCT00246441

Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Social Anxiety Disorder
• Social Phobia
• Alcohol Use Disorder
• Alcohol Abuse
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Paroxetine	16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day
DRUG	Placebo	treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.

Timeline

• Start date: 2002-03-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-10-31
• Last updated: 2018-09-27
• Results posted: 2018-09-27

Locations

1 site across 1 country: United States