Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

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.

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