Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

NCT00352469 | Completed Phase 4 DMC

• 1 other identifier: IRUSQUET408
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alcoholism; Anxiety Disorders; Generalized Anxiety Disorder; Post-Traumatic Stress Disorder; Panic Disorder; Obsessive-Compulsive Disorder

Keywords

Alcoholism; Anxiety; GAD; PTSD; Panic Disorder; OCD

Outcome Measures

Primary Outcomes (1)

• 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.

  Two Years

Secondary Outcomes (2)

• 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.

  Two Years

• 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.

  Two years

Study Arms (1)

2

PLACEBO COMPARATOR

Subjects will be randomized to receive either Seroquel SR or placebo

Drug: Seroquel XR

Interventions

Seroquel XR DRUG

Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg

2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Creighton University: lead
• AstraZeneca: collaborator

Study Sites (1)

Creighton University Department of Psychiatry

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders; Generalized Anxiety Disorder; Stress Disorders, Post-Traumatic; Panic Disorder; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Pirzada Sattar, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 8, 2008

Record last verified: 2008-12

Locations

US (1)