CompletedNCT00674765Updated Sep 17, 2014Results posted

Seroquel for Frequent, Heavy Drinkers

A Phase 2 interventional study of Seroquel and Placebo in Alcoholism, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 156
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Alcoholism

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In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 156 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 156 participants (actual)

Study arms

Experimental
1
Seroquel
Drug: Seroquel
Placebo comparator
2
Placebo
Drug: Placebo

Interventions

DrugSeroquel
400 mg/day
Also known as: quetiapine
DrugPlacebo
400 mg/day

What researchers measure

Primary outcomes

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

Results

Posted Sep 17, 2014

Participant flow

Participant flow — Overall Study
Milestone	Seroquel	Placebo
Started	81	75
Completed	45	46
Not completed	36	29

Outcome measures

PrimaryTimeLine 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
Reported as:: Number · percent days of heavy drinking

TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase
percent days of heavy drinking	Seroquel (Quetiapine)	Placebo Sugar Pill
TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase	20	24

Statistical analysis

Seroquel (Quetiapine) vs Placebo Sugar Pill · t-test, 2 sided · p = .388t=.87

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Seroquel	—	0/81 (0%)	76/81 (93.8%)
Placebo	—	0/75 (0%)	41/75 (54.7%)

Most frequent other events

Most frequent other events
Event	Seroquel	Placebo
SedationGeneral disorders	43/81	22/75
Dry MouthGeneral disorders	16/81	6/75
Increased appetiteMetabolism and nutrition disorders	13/81	6/75
HeadacheGeneral disorders	4/81	7/75

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Seroquel	Placebo	Total
Mean	43.0 ± 9.9	45.4 ± 11.3	44.4 ± 10.1

Age, Categorical
Age, Categorical(Participants)	Seroquel	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	81	75	156
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Seroquel	Placebo	Total
Female	16	15	31
Male	65	60	125

Region of Enrollment
Region of Enrollment(participants)	Seroquel	Placebo	Total
United States	81	75	156

Study locations

1 site

University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania 19104, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00674765
Lead sponsor: University of Pennsylvania
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party: Sponsor
First posted: May 8, 2008
Start date: Jan 2008
Primary completion: Jan 2013
Completion: Jan 2014
Results posted: Sep 17, 2014
Last update: Sep 17, 2014

Study contacts

Kyle M Kampman, M.D.

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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