Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Condition: Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism; Anxiety Disorders; Phobia, Social
Intervention: Paroxetine; Placebo
Intervention description: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day; 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.
Intervention MeSH terms: Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pharmacotherapy; Self medication

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.
    

Eligibility 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