NCT00862212

Brief Summary

The purpose of this study is to treat individuals with social anxiety disorder with a Food and Drug Administration-approved medication for the treatment of social anxiety disorder, the antidepressant paroxetine, and to evaluate the impact of an intervention designed to help those individuals cope with anxiety without the use of common coping behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

3.5 years

First QC Date

March 13, 2009

Last Update Submit

April 22, 2013

Conditions

Social Anxiety DisorderAlcohol Use Disorders

Keywords

anxietysocial anxietysocial anxiety disordercoping behaviorsalcohol abuse

Outcome Measures

Primary Outcomes (1)

  • alcohol use, as indexed by (1) Drinks per Week and (2) Drinks per Drinking Day

    22 weeks

Secondary Outcomes (1)

  • alcohol intervention effect on hazardous drinker status

    Weeks 6-22

Study Arms (2)

Brief Alcohol Intervention

EXPERIMENTAL

Half of the subjects will be randomly assigned to receive a brief physician-delivered alcohol intervention designed by the NIAAA to be delivered by primary care and mental health providers.

Behavioral: Brief Alcohol Intervention

Control Group

NO INTERVENTION

Interventions

Brief Alcohol InterventionBEHAVIORAL

At the Week 6 visit, all subjects who are randomized to the Experimental Group will receive the experimental brief alcohol intervention. The intervention will be in addition to a standard 20-minute physician visit, for a maximum of 30 minutes. The physician will use the Updated NIAAA Clinician's Guide to ask about drinking and will draw the connection between social anxiety and drinking and how they relate to each other. Subjects will be asked to consider making changes in their drinking and if they agree, a goal will be set and progress toward that goal will be monitored at subsequent visits.

Also known as: Helping Patients That Drink Too Much, NIAAA Guide
Brief Alcohol Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65.
  • Meets DSM-IV criteria for Social Anxiety Disorder, generalized type.
  • LSAS score greater than or equal to 60.
  • Reports drinking at least 15 standard drinks/week or 5 standard drinks/drinking day for men, and at least 8 standard drinks/week or 4 standard drinks/drinking day for women in the past 30 days.
  • AUDIT score between 8 and 15 inclusive for men and 4 and 15 inclusive for women.
  • Reports no prior medical alcohol detoxification or formal alcohol treatment including regular attendance at self-help groups.
  • Treatment seeking for relief of social anxiety, not for alcohol problems.
  • Endorses drinking to cope with anxiety at least 40% of the time during or before a social situation, using the Drinking to Cope survey.
  • Able to provide informed consent and fill out self-rating forms in English.

You may not qualify if:

  • Drug dependence in the past 90 days on any drug besides caffeine or nicotine.
  • Lifetime diagnosis of bipolar disorder or schizophrenia.
  • Significant suicide risk as assessed by the SCID.
  • Current use of psychotropic medications.
  • Pregnancy, nursing or refusal to use effective birth control if female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Phobia, SocialAlcoholismAnxiety Disorders

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Phobic DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Officials

  • Carrie L Randall, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Matthew Kushner, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

US(2)