Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety - Full Text View

Sponsors and Collaborators:	Creighton University AstraZeneca
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00352469

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Anxiety Obsessive-Compulsive Disorder Panic Disorder Post-Traumatic Stress Disorder

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:

Aim 1: To determine whether Seroquel SR reduces alcohol use and prolongs sobriety as measured by the Time Line Follow Back Method and breathalyzer test in individuals with alcohol dependence and co-morbid anxiety. [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Aim 2: To determine whether Seroquel SR decreases craving as measured by the Pennsylvania Craving Scale, in individuals with alcohol dependence and co-morbid anxiety. [ Time Frame: Two Years ] [ Designated as safety issue: No ]
Aim 3: To determine whether Seroquel SR reduces anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety (HAM-A), in individuals with alcohol dependence and co-morbid anxiety. [ Time Frame: Two years ] [ Designated as safety issue: No ]

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
2: Placebo Comparator Subjects will be randomized to receive either Seroquel SR or placebo	Drug: Seroquel XR Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg

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 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.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352469

Locations

United States, Nebraska
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

AstraZeneca

Investigators

Principal Investigator:

Pirzada Sattar, MD

Creighton University

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Creighton University:

Alcoholism
Anxiety
GAD

PTSD
Panic Disorder
OCD

Study placed in the following topic categories:

Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Stress
Disorders of Environmental Origin
Antipsychotic Agents
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

Additional relevant MeSH terms:

Tranquilizing Agents
Disease
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Antipsychotic Agents
Pharmacologic Actions
Stress Disorders, Traumatic
Panic Disorder
Quetiapine

Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Alcohol-Related Disorders
Central Nervous System Agents
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on September 03, 2009