Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Paroxetine

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