Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

December 5, 2008 updated by: Creighton University

12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Male and female patients between 19-65 years of age.
  4. Ability to provide informed consent.
  5. Medically and psychiatrically stable defined as not requiring inpatient treatment.

Exclusion Criteria:

  1. Inability to provide informed consent.
  2. Need for inpatient treatment
  3. Need for inpatient detoxification for substance other than alcohol
  4. Evidence of active dependence on a substance other than alcohol (with the exception of nicotine) as assessed by a urine drug screen.
  5. Medically or psychiatrically unstable patients, defined as requiring inpatient treatment.
  6. Pregnancy, nursing or refusal to use a reliable method of birth control in women.
  7. Current treatment with other antipsychotic medications, which cannot be switched to Seroquel SR.
  8. Patients with known allergy to Seroquel IR/SR or treatment failure to Seroquel IR/SR.
  9. Exclude patients (pts) with unstable diabetes.
  10. Exclude pts over 65
  11. Exclude pts with dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Two Years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Pirzada Sattar, MD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSQUET408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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