A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers.

NCT00498628 Phase 2 COMPLETED Results posted

The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.

Details

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase	Phase 2
Status	COMPLETED
Enrolment	224
Start date	2007-12
Completion	2010-03

Conditions

• Alcoholism
• Alcohol Abuse

Interventions

• Quetiapine fumarate
• Placebo

Primary outcomes

• Percent Heavy Drinking Days — Weeks 3 - 11
  A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.

Countries

United States