Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Completed · Phase 4 · Has a placebo group

Conditions studied: Social Anxiety Disorder, Social Phobia, Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT00246441

Run by

Medical University of South Carolina

People needed

42

Starts

2002-03-01

Expected to finish

2008-02-01

Last updated by the study team

2018-09-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina, Institute of Psychiatry — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.