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Naltrexone for Alcohol Dependence (DEFINE II)
NCT00817089Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2007
- Primary completion
- Apr 2010
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Small Molecules
- Drugs
- naltrexone
- Conditions
- alcohol dependence
01
Overview
Phase 4, randomised, double-blind trial of naltrexone in alcohol dependence, sponsored by University of Pennsylvania. Started Dec 2007; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Registry description
This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcohol dependence and treatment by defining an endophenotype associated with treatment response. The study consists of two inpatient alcohol challenge sessions with treatment using random assignment to either naltrexone or placebo.
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