Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3 approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety disorders is unknown. This study explores the effects of the medication, sustained-release quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures include craving for alcohol, length of sobriety from drinking and level of anxiety with Seroquel SR.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creighton University
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

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