Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

STUDY OBJECTIVES:

The objective of this proposal is to study the efficacy of the medication Seroquel SR for the
treatment of alcohol dependence and co-morbid anxiety in a prospective double blind
placebo-controlled randomized clinical study. Patients, meeting the DSM-IV criteria for
Alcohol Dependence and an Anxiety Disorder, will be enrolled and randomized to receive
placebo or Seroquel SR. All subjects will be referred to usual treatment program, where they
can receive group/self help group therapy.

Method:

This is a 12-week prospective, double blind placebo-controlled randomized clinical trial of
Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric
Disorders (DSM-IV) criteria for alcohol dependence and anxiety disorders. Potential
candidates will be allowed sufficient time to review the consent document and ask questions
about the trial prior to signing the consent document. Consenting adults will be randomized
to receive active medication, Seroquel SR or placebo for 12-weeks. The study will enroll 20
patients, 10 will be randomized to receive Seroquel SR, and 10 will receive placebo. All
participants will also be referred to usual alcohol treatment, including individual, group
and/or self help group therapy (Alcoholics Anonymous).

Subjects will be randomized to receive either Seroquel SR or placebo. Dosing of Seroquel SR
will occur on the following schedule: At the baseline visit, Seroquel SR will be started at
50 mg QHS for Day 1 and 2, and dose increase to 150 mg QHS on day 3-4, and increased further
to 300 mg QHS from day 5-day 42. After day 5, the Seroquel SR dosage can be increased by up
to 100 mg per week to a maximal dose of 400 mg per day. During the treatment period, dose
reductions (because of physical illness or adverse event) are allowed for patients taking at
least 200 mg per day.

Inclusion Criteria:

1. Diagnosis of alcohol dependence and an anxiety disorder (generalized anxiety disorder,
post traumatic disorder, panic disorder, obsessive compulsive disorder, etc.) based on
Mini-International Neuropsychiatric Interview (MINI) for DSM IV.

2. Subject reports a minimum of 48 standard alcoholic drinks (or an average of 12
drinks/wk) in a consecutive 30-day period (i.e., a minimum of 40% days drinking), and
has 2 or more days of heavy drinking (defined as ≥5 drinks/day in males and ≥4
drinks/day in females) in this same period as measured by the Time Line Follow Back.

3. Male and female patients between 19-65 years of age.

4. Ability to provide informed consent.

5. Medically and psychiatrically stable defined as not requiring inpatient treatment.

Exclusion Criteria:

1. Inability to provide informed consent.

2. Need for inpatient treatment

3. Need for inpatient detoxification for substance other than alcohol

4. Evidence of active dependence on a substance other than alcohol (with the exception of
nicotine) as assessed by a urine drug screen.

5. Medically or psychiatrically unstable patients, defined as requiring inpatient
treatment.

6. Pregnancy, nursing or refusal to use a reliable method of birth control in women.

7. Current treatment with other antipsychotic medications, which cannot be switched to
Seroquel SR.

8. Patients with known allergy to Seroquel IR/SR or treatment failure to Seroquel IR/SR.

9. Exclude patients (pts) with unstable diabetes.

10. Exclude pts over 65

11. Exclude pts with dementia