Status:
COMPLETED
Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Lead Sponsor:
Creighton University
Collaborating Sponsors:
AstraZeneca
Conditions:
Alcoholism
Anxiety Disorders
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief 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 fo...
Detailed Description
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 pla...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Male and female patients between 19-65 years of age.
- Ability to provide informed consent.
- Medically and psychiatrically stable defined as not requiring inpatient treatment.
Exclusion
- Inability to provide informed consent.
- Need for inpatient treatment
- Need for inpatient detoxification for substance other than alcohol
- Evidence of active dependence on a substance other than alcohol (with the exception of nicotine) as assessed by a urine drug screen.
- Medically or psychiatrically unstable patients, defined as requiring inpatient treatment.
- Pregnancy, nursing or refusal to use a reliable method of birth control in women.
- Current treatment with other antipsychotic medications, which cannot be switched to Seroquel SR.
- Patients with known allergy to Seroquel IR/SR or treatment failure to Seroquel IR/SR.
- Exclude patients (pts) with unstable diabetes.
- Exclude pts over 65
- Exclude pts with dementia
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00352469
Start Date
February 1 2006
End Date
November 1 2008
Last Update
December 8 2008
Active Locations (1)
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1
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131