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Quetiapine XR for Alcohol Dependence
NCT00498628Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2007
- Primary completion
- Aug 2009
- Countries
- 1
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism
- Modality
- Small Molecules
- Drugs
- quetiapine
- Conditions
- alcohol dependence
01
Overview
Phase 2, randomised, double-blind trial in alcohol dependence comparing Quetiapine XR with Placebo (2 arms). Primary endpoint: Percent Heavy Drinking Days. Started Dec 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Quetiapine XR
Quetiapine fumarate XR + Medical Management
Placebo
Placebo + Medical Management
03
Endpoints
Primary
Percent Heavy Drinking Days
Secondary
Percent Days Abstinent
Drinks Per Drinking Day
Drinks Per Day
Percent Very Heavy Drinking Day
Percent Subjects Abstinent
Percent Subjects With no Heavy Drinking Day
Drinking Consequences Score
Penn Alcohol Craving Score
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