Alcoholism
Conditions
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.
Interventions
DRUGSeroquel
400 mg/day
DRUGPlacebo
400 mg/day
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male and females, 18-70 years old. 2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}. 3. Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}: 4. Three consecutive days of abstinence from alcohol immediately before randomization 5. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits. 6. Speaks, understands, and prints in English.
Exclusion criteria
1. Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana). 2. 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. 3. 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. 4. 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. 5. Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication. 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 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. 7. Has known hypersensitivity to antipsychotics. 8. Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization. 9. A history of seizure disorder. 10. The presence of cataracts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Seroquel Seroquel
Seroquel: 400 mg/day | 81 |
| Placebo Placebo
Placebo: 400 mg/day | 75 |
| Total | 156 |
Baseline characteristics
| Characteristic | Seroquel | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 75 Participants | 156 Participants |
| Age, Continuous | 43.0 years STANDARD_DEVIATION 9.9 | 45.4 years STANDARD_DEVIATION 11.3 | 44.4 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 81 participants | 75 participants | 156 participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 65 Participants | 60 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 76 / 81 | 41 / 75 |
| serious Total, serious adverse events | 0 / 81 | 0 / 75 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seroquel (Quetiapine) | TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase | 20 percent days of heavy drinking |
| Placebo Sugar Pill | TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase | 24 percent days of heavy drinking |
p-value: 0.388t-test, 2 sided