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Sponsors and Collaborators: |
Creighton University AstraZeneca |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00352469 |
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.
Condition | Intervention | Phase |
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Alcoholism Anxiety Disorders Generalized Anxiety Disorder Post-Traumatic Stress Disorder Panic Disorder Obsessive-Compulsive Disorder |
Drug: Seroquel XR |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety |
Estimated Enrollment: | 20 |
Study Start Date: | February 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Subjects will be randomized to receive either Seroquel SR or placebo
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Drug: Seroquel XR
Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg
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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.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
Creighton University Department of Psychiatry | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Pirzada Sattar, MD | Creighton University |
Responsible Party: | Creighton University Department of Psychiatry ( S. Pirzada Sattar, M.D., Assistant Professor ) |
Study ID Numbers: | IRUSQUET408 |
Study First Received: | July 12, 2006 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00352469 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Alcoholism Anxiety GAD |
PTSD Panic Disorder OCD |
Stress Disorders of Environmental Origin Stress Disorders, Traumatic Panic Disorder Quetiapine Anxiety Disorders Mental Disorders |
Alcoholism Substance-Related Disorders Stress Disorders, Post-Traumatic Alcohol-Related Disorders Obsessive-Compulsive Disorder Ethanol |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |