Seroquel for Frequent, Heavy Drinkers

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00674765
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 156
• Location: 1
• Arms: 2
• Duration (Months): 72
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: Seroquel; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Seroquel	Drug: Seroquel; 400 mg/day; Other Names: quetiapine
Placebo Comparator: 2 Placebo	Drug: Placebo; 400 mg/day

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication.

2. 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.

3. Has known hypersensitivity to antipsychotics.

4. Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization.

5. A history of seizure disorder.

6. The presence of cataracts.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania, Treatment Research Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Kyle M Kampman, M.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00674765
• Other Study ID Numbers: 807057 - Kampan_AA016553; NIH Grant 1R01AA016553-01A1
• First Posted: May 8, 2008
• Last Update Posted: Sep 17, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Alcoholism; Alcoholic Intoxication; Quetiapine Fumarate

Study Results

Participant Flow

Arm/Group Title	Seroquel	Placebo
Arm/Group Description	Seroquel Seroquel: 400 mg/day	Placebo Placebo: 400 mg/day
Period Title: Overall Study
STARTED	81	75
COMPLETED	45	46
NOT COMPLETED	36	29

Baseline Characteristics

Arm/Group Title	Seroquel	Placebo	Total
Arm/Group Description	Seroquel Seroquel: 400 mg/day	Placebo Placebo: 400 mg/day	Total of all reporting groups
Overall Participants	81	75	156
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.0 (9.9)	45.4 (11.3)	44.4 (10.1)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	81 100%	75 100%	156 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	16 19.8%	15 20%	31 19.9%
Male	65 80.2%	60 80%	125 80.1%
Region of Enrollment (participants) [Number]
United States	81 100%	75 100%	156 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seroquel (Quetiapine)	Placebo Sugar Pill
Arm/Group Description	Seroquel (quetiapine) Seroquel: 400 mg/day	Placebo Placebo: 400 mg/day
Measure Participants	81	75
Number [percent days of heavy drinking]	20	24

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Seroquel (Quetiapine), Placebo Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.388
	Comments
	Method	t-test, 2 sided
	Comments	t=.87

Adverse Events

Arm/Group Title	Seroquel		Placebo
Arm/Group Description	Seroquel Seroquel: 400 mg/day		Placebo Placebo: 400 mg/day
All Cause Mortality
	Seroquel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Seroquel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Seroquel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	76/81 (93.8%)		41/75 (54.7%)
General disorders
Sedation	43/81 (53.1%)		22/75 (29.3%)
Dry Mouth	16/81 (19.8%)		6/75 (8%)
Headache	4/81 (4.9%)		7/75 (9.3%)
Metabolism and nutrition disorders
Increased appetite	13/81 (16%)		6/75 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.