Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

This study has been completed.

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT00246441

First received: October 28, 2005

Last updated: December 1, 2016

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 28, 2005

Last Updated Date

December 1, 2016

Start Date ^ICMJE

March 2002

Primary Completion Date

February 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Social anxiety severity [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]
Alcohol use, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]
Drinking to cope, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]

Original Primary Outcome Measures ^ICMJE

Social anxiety severity
Alcohol use, quantity and frequency
Drinking to cope, quantity and frequency

Change History

Complete list of historical versions of study NCT00246441 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]
Depressive symptoms [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]

Original Secondary Outcome Measures ^ICMJE

Quality of life
Depressive symptoms

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

Condition ^ICMJE

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

Intervention ^ICMJE

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.

Study Arms

Experimental: 1
Paroxetine

Intervention: Drug: Paroxetine
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Meets DSM-IV criteria for current social anxiety disorder
Reports social anxiety in most situations (generalized type).
Treatment seeking for relief of social anxiety.
Meets DSM-IV criteria for current alcohol use disorder
Reads at the 6th grade level or above
Endorses using alcohol to cope with social anxiety either "very often" or "always."
Reports no prior medical alcohol detoxification
Willingness to be randomized to the placebo group
Willingness to attend 16 weekly medication management visits and one alcohol-related therapy session
Liebowitz Social Anxiety Scale Total score (modified version) of at least 60
Endorses drinking at least 15 standard drinks in a typical 30 day period or reports drinking heavily (defined as greater-than-or-equal-to 4 standard drinks on one occasion for women; greater-than-or-equal-to 5 standard drinks on one occasion for men, respectively) on at least 2 days in a typical 30 day period.

Exclusion Criteria:

Abuse or dependence on drugs other than nicotine or marijuana in last 90 days
Current or past diagnosis of bipolar disorder or schizophrenia
Significant suicide risk as assessed by the SCID
Current use of psychotropic medications
Treatment seeking for alcohol problems
Any unstable medical condition that might interfere with safe participation in the trial
Elevated liver enzymes (3 x greater than normal levels)
History of adverse reaction to paroxetine
History of failure to respond to adequate trial or dose of paroxetine for social phobia (60 mg/day for at least 6 weeks)
History of heart problems or abnormal ECG recording
Pregnancy, nursing, or refusal to use effective birth control if sexually active and premenopausal
History of one or more alcohol detoxifications

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

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

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

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

Principal Investigator:

Carrie L Randall, PhD

Medical University of South Carolina

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

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