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Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Primary Purpose

Social Anxiety Disorder, Social Phobia, Alcohol Use Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paroxetine
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Pharmacotherapy, Self medication

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina, Institute of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paroxetine

Placebo

Arm Description

Active medication containing the drug Paroxetine

A Placebo medication that appears just like the active medication but does not contain placebo

Outcomes

Primary Outcome Measures

Social Anxiety Severity
Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.
Alcohol Use, Quantity and Frequency
Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is >0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).
Drinking to Cope
Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2005
Last Updated
September 25, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00246441
Brief Title
Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Official Title
Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Social Phobia, Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence
Keywords
Pharmacotherapy, Self medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paroxetine
Arm Type
Experimental
Arm Description
Active medication containing the drug Paroxetine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A Placebo medication that appears just like the active medication but does not contain placebo
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Other Intervention Name(s)
paxil
Intervention Description
16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Anxiety Severity
Description
Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.
Time Frame
16 weeks treatment
Title
Alcohol Use, Quantity and Frequency
Description
Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is >0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).
Time Frame
16 weeks treatment
Title
Drinking to Cope
Description
Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.
Time Frame
16 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie L Randall, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina, Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

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