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Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00246441
First received: October 28, 2005
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Social Anxiety Disorder
Social Phobia
Alcohol Use Disorder
Alcohol Abuse
Alcohol Dependence
Drug: Paroxetine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Social anxiety severity [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]
  • Alcohol use, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]
  • Drinking to cope, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2002
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Paroxetine
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
Placebo Comparator: 2
Placebo
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246441

Locations
United States, South Carolina
Medical University of South Carolina, Institute of Psychiatry
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Carrie L. Randall, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Carrie L. Randall, PhD, Principal Investigator, Medical University of South Carolina, Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00246441     History of Changes
Other Study ID Numbers: NIAAARAN013379, R01AA013379, NIH Grant R01 AA013379
Study First Received: October 28, 2005
Last Updated: November 17, 2009
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
Pharmacotherapy
Self medication

Additional relevant MeSH terms:
Alcoholism
Anxiety Disorders
Disease
Phobic Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Substance-Related Disorders
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014