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

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Seroquel
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcohol dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female and 18-65 years old. Has a DSM-IV diagnosis of current alcohol dependence. 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). 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.] 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. Speaks, understands and prints in English. Gives written informed consent. Exclusion Criteria: 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. 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). 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. 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. 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); 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. Has known hypersensitivity to antipsychotics. Has participated in any investigational drug trial within 30 days prior to the study. History of seizures including alcohol withdrawal seizures. History of head trauma. Family history of seizures.

Sites / Locations

  • University of Pennsylvania Treatment Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Type A SERO

Type B SERO

Type A PLA

Type B PLA

Arm Description

Outcomes

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).

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

Full Information

First Posted
July 22, 2005
Last Updated
October 2, 2015
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00124059
Brief Title
Quetiapine Fumarate (Seroquel) for the Treatment of Alcohol Dependence.
Official Title
A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcohol dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type A SERO
Arm Type
Experimental
Arm Title
Type B SERO
Arm Type
Experimental
Arm Title
Type A PLA
Arm Type
Placebo Comparator
Arm Title
Type B PLA
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Seroquel
Intervention Description
400mg/day quetiapine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
400mg/day placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female and 18-65 years old. Has a DSM-IV diagnosis of current alcohol dependence. 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). 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.] 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. Speaks, understands and prints in English. Gives written informed consent. Exclusion Criteria: 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. 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). 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. 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. 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); 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. Has known hypersensitivity to antipsychotics. Has participated in any investigational drug trial within 30 days prior to the study. History of seizures including alcohol withdrawal seizures. History of head trauma. Family history of seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M Pettinati, PhD
Organizational Affiliation
University of Pennsylvania Treatment Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Treatment Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17632217
Citation
Kampman KM, Pettinati HM, Lynch KG, Whittingham T, Macfadden W, Dackis C, Tirado C, Oslin DW, Sparkman T, O'Brien CP. A double-blind, placebo-controlled pilot trial of quetiapine for the treatment of Type A and Type B alcoholism. J Clin Psychopharmacol. 2007 Aug;27(4):344-51. doi: 10.1097/JCP.0b013e3180ca86e5.
Results Reference
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Quetiapine Fumarate (Seroquel) for the Treatment of Alcohol Dependence.

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