Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Completed · Phase 4
Conditions studied: Alcoholism, Anxiety Disorders, Generalized Anxiety Disorder, Post-Traumatic Stress Disorder, Panic Disorder, Obsessive-Compulsive Disorder
In brief
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.
Key facts
- Study ID
- NCT00352469
- Run by
- Creighton University
- People needed
- 20
- Starts
- 2006-02-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2008-12-08
Who can join
Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Creighton University Department of Psychiatry — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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