Official Title: “Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Paroxetine
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Social anxiety severity
  • Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews
    Safety Issue?: No
• Alcohol use, quantity and frequency
  • Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews
    Safety Issue?: No
• Drinking to cope, quantity and frequency
  • Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews
    Safety Issue?: No

Secondary Measures

• Quality of life
  • Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews
    Safety Issue?: No
• Depressive symptoms
  • Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Overall Clinical Trial Officials and Contacts

Carrie L. Randall, PhD Principal Investigator Medical University of South Carolina  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00246441

Study ID Number: NIAAARAN013379

ClinicalTrials.gov Identifier: NCT00246441

Health Authority: United States: Federal Government