Back to resultsSeroquel for Frequent, Heavy Drinkers
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Seroquel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility Criteria
Inclusion Criteria:
- Male and females, 18-70 years old.
- Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}.
- Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}:
- Three consecutive days of abstinence from alcohol immediately before randomization
- Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
- Speaks, understands, and prints in English.
Exclusion Criteria:
- Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana).
- Tests positive on the urine drug screen during the screening weeks (one retest allowed). Subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the PI, if they are known to be physician-prescribed for detox purposes.
- 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), with associated elevations of AST and ALT above normal limits.
Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness.
Has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
- Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication.
- 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 patient is of child-bearing potential, meaning has not had a hysterectomy or is in menopause, meaning 50 or over and has not had a menstrual cycle in 12 months.
- Has known hypersensitivity to antipsychotics.
- Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization.
- A history of seizure disorder.
- The presence of cataracts.
Sites / Locations
- University of Pennsylvania, Treatment Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Seroquel
Placebo
Outcomes
Primary Outcome Measures
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase
The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.
Secondary Outcome Measures
Full Information
NCT ID
NCT00674765
First Posted
May 6, 2008
Last Updated
September 16, 2014
Sponsor
University of Pennsylvania
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00674765
Brief Title
Seroquel for Frequent, Heavy Drinkers
Official Title
A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.
Detailed Description
This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Seroquel
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Seroquel
Other Intervention Name(s)
quetiapine
Intervention Description
400 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
400 mg/day
Primary Outcome Measure Information:
Title
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase
Description
The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and females, 18-70 years old.
Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}.
Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}:
Three consecutive days of abstinence from alcohol immediately before randomization
Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
Speaks, understands, and prints in English.
Exclusion Criteria:
Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana).
Tests positive on the urine drug screen during the screening weeks (one retest allowed). Subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the PI, if they are known to be physician-prescribed for detox purposes.
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), with associated elevations of AST and ALT above normal limits.
Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness.
Has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication.
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 patient is of child-bearing potential, meaning has not had a hysterectomy or is in menopause, meaning 50 or over and has not had a menstrual cycle in 12 months.
Has known hypersensitivity to antipsychotics.
Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization.
A history of seizure disorder.
The presence of cataracts.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle M Kampman, M.D.
Organizational Affiliation
University of Pennsylvania
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
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Seroquel for Frequent, Heavy Drinkers
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