NCT00817089

Understanding Treatment Response With Naltrexone Among White Alcoholics

Defining an Endopheneotype for Alcohol Treatment With Naltrexone

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Male
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Despite the well-established efficacy of naltrexone, there are significant variations in individual responses to naltrexone. A critical question remains: under what circumstances and for which patients will naltrexone be most beneficial? Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. We have shown that patients with Asn40 variant (absence of heavy drinking -73.9% v/s 49% response). To further consolidate our knowledge, we wish to test the relationship between A118G polymorphism and the subjective/objective measures to alcohol among alcoholics treated with naltrexone. This work is focused on subjects of European or Asian decent as the A118G polymorphism occurs in less than 1% of those of African decent. Up to 40 subjects will be recruited. The subjects were admitted to the UPenn Translational Research Center and receive two alcohol challenge sessions after pretreatment with naltrexone or placebo.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	Placebo pill
DRUG	Naltrexone	50 mg of naltrexone prior to challenge session

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2009-01-06
• Last updated: 2019-11-21
• Results posted: 2019-11-21

Locations

1 site across 1 country: United States