Seroquel for Frequent, Heavy Drinkers

Condition(s) targeted: Alcoholism

Intervention: Seroquel (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official(s) and/or principal investigator(s):
Kyle M Kampman, M.D., Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Kyle M Kampman, MD, Phone: 215-222-3200, Ext: 109, Email: kampman_k@mail.trc.upenn.edu

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.

Official title: A Phase II Double-Blind, Placebo-Controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: TimeLine Follow Back (TLFB) to measure percent abstinent days and percent heavy drinking days during the medication/placebo phase

Secondary outcome: TLFB data on percent of heavy drinking days and percent of days abstinant during the follow-up phase; Comparison of HAM A, HAM D and ISI scores

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and females, 18-70 years old.

- Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the

SCID-IV {First, 1996 #34}.

- Meets the following drinking criteria, measured by TLFB and the Addiction Severity

Index {McLellan, 1992 #37}: a. drank to intoxication 15 of the previous 30 days prior to entering the trial, defined in the ASI as drinking to achieve a "high or buzz" and operationally defined as 3 or more drinks in one sitting of 1-2 hours. b. reports an average of 12 standard drinks per drinking day for men (10 for women) in the 30 days prior to entering the trial [Note: This level of drinking predicted a positive response to quetiapine in our pilot trial].

- Three consecutive days of abstinence from alcohol, determined by self-reports and

confirmed by a negative breathalyzer tests immediately before the day of randomization, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) {Sullivan, 1989 #97} score below eight on the day of 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), tests

positive on the urine drug screen in the screening week (one retest allowed).

- 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).

- Meets diagnostic criteria for a current unstable or serious psychiatric or medical

illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; 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 (with the exception of detoxification medications or benadryl used sparingly for sleep).

- 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.

- Has known hypersensitivity to antipsychotics.

- Has participated in any investigational drug trial within 30 days prior to the study.

- A history of seizures.

- The presence of cataracts.

Kyle M Kampman, MD, Phone: 215-222-3200, Ext: 109, Email: kampman_k@mail.trc.upenn.edu

University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Donna Simpson, Phone: 215-222-3200, Ext: 158, Email: Simpson_D@mail.trc.upenn.edu
Kyle M Kampman, MD, Principal Investigator

Starting date: January 2008
Ending date: June 2011
Last updated: May 7, 2008