Quetiapine Fumarate (Seroquel) for the Treatment of Alcohol Dependence.

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00124059
First received: July 22, 2005
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine whether seroquel is effective in the treatment of type A and type B alcohol dependence.


Condition Intervention Phase
Alcoholism
Drug: Seroquel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics.

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • TLFB (TimeLine FollowBack) for 1) proportion of days abstinent; 2) proportion of days of heavy drinking; 3) time to the return of heavy drinking (drinking heavily for 2 out of 30 days). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Patient acceptability of the pharmacotherapy (measured by treatment drop outs and pill noncompliance) 2. Changes in craving for alcohol over the course of treatment 3. Changes in any mood and anxiety symptoms over the course of treatment [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: March 2003
Study Completion Date: October 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Type A SERO Drug: Seroquel
400mg/day quetiapine
Experimental: Type B SERO Drug: Seroquel
400mg/day quetiapine
Placebo Comparator: Type A PLA Drug: Placebo
400mg/day placebo
Placebo Comparator: Type B PLA Drug: Placebo
400mg/day placebo

Detailed Description:

The purpose of this study is to obtain preliminary data regarding the safety, efficacy and tolerability of quetiapine [Seroquel (SQL)] in treating Type A vs B alcohol dependent outpatients seeking treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female and 18-65 years old.
  2. Has a DSM-IV diagnosis of current alcohol dependence.
  3. Has either Type A or Type B alcohol dependence, determined by cut-off scores for drinking amounts per day (TLFB), depression symptoms (Hamilton Depression Rating Scale--HDRS; Hamilton, 1967), and number of childhood antisocial personality symptoms. These three variables were selected based on recently published data on alcohol subtyping by Pettinati et al., 2000b).
  4. Meets the following drinking criteria, measured by TLFB: a. drink within 30 days of starting pharmacotherapy treatment, b. reports a minimum of 48 standard alcoholic drinks (avg 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting pharmacotherapy (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period. [Note: To be a subject in the study, the patient must have been drinking enough in the 90 days before the trial so that a baseline exists in order to then measure reductions in drinking during the trial.]
  5. Prior to starting pharmacotherapy, scores below 8 on the Clinical Institutes Withdrawal Assessment for Alcohol (CIWA; Shaw et al, 1981), and has at least 3 consecutive days of abstinence, as determined by subject report, breathalyzer measures, and a collateral report.
  6. Speaks, understands and prints in English.
  7. Gives written informed consent.

Exclusion Criteria:

  1. Has evidence of dependence on a substance other than alcohol (except nicotine), test positive on the urine drug screen (with the exception of THC) in the screening week (only one repeat testing permitted), or require inpatient detoxification for any substance.
  2. Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (>1.3).
  3. Patients with hepatocellular disease as evidenced by AST or ALT levels at least 2 times normal who test positive on a screening test for hepatitis A, B or C.
  4. Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
  5. Has taken any psychotropic medications (or disulfiram) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep);
  6. Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the S is of child-bearing potential.
  7. Has known hypersensitivity to antipsychotics.
  8. Has participated in any investigational drug trial within 30 days prior to the study.
  9. History of seizures including alcohol withdrawal seizures.
  10. History of head trauma.
  11. Family history of seizures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124059

Locations
United States, Pennsylvania
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Helen M Pettinati, PhD University of Pennsylvania Treatment Research Center
  More Information

Publications:
Responsible Party: Helen Pettinati Ph.D., University of Pennsylvania Treatment Research Center
ClinicalTrials.gov Identifier: NCT00124059     History of Changes
Other Study ID Numbers: 706689
Study First Received: July 22, 2005
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014