Status:
COMPLETED
Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Social Anxiety Disorder
Social Phobia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00246441
Start Date
March 1 2002
End Date
February 1 2008
Last Update
September 27 2018
Active Locations (1)
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1
Medical University of South Carolina, Institute of Psychiatry
Charleston, South Carolina, United States, 29425