Seroquel for Frequent, Heavy Drinkers

NCT00674765 | Completed Phase 2 Results DMC

• 2 other identifiers: 807057 - Kampan_AA016553NIH Grant 1R01AA016553-01A1
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Seroquel

Drug: Seroquel

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Seroquel DRUG

400 mg/day

Also known as: quetiapine

1

Placebo DRUG

400 mg/day

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Kyle Kampman
• Organization: University of Pennsylvania

kampman@mail.med.upenn.edu

215-222-3200

Study Officials

• Kyle M Kampman, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 17, 2014
• Results First Posted: September 17, 2014

Record last verified: 2014-09

Locations

US (1)