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Report for Clinical Trial NCT00817089

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Defining an Endopheneotype for Alcohol Treatment With Naltrexone

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.

NCT00817089 Alcoholism
MeSH:Alcoholism

2 Interventions

Name: Placebo Oral Tablet

Description: Placebo pill
Type: Drug
Group Labels: 5

Group 1 Asn40 Placebo Placebo Group 2 Asn40 Placebo Naltre Group 2 Asn40 Placebo Naltrexone Group 3 Asp40 Placebo Placebo Group 4 Asp40 Placebo Naltrexone

Name: Naltrexone

Description: 50 mg of naltrexone prior to challenge session
Type: Drug
Group Labels: 2

Group 2 Asn40 Placebo Naltrexone Group 4 Asp40 Placebo Naltrexone


Primary Outcomes

Description: Change from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood. Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes.

Measure: Biphasic Alcohol Effects Scale:Total Mood

Time: during 2nd alcohol challenge session

Secondary Outcomes

Description: Change from baseline to peak cortisol response during the 2nd alcohol challenge session, objective response as measured by Adrenocorticotropic hormone (ACTH).

Measure: Adrenocorticotropic Hormone (ACTH) Levels

Time: during 2nd alcohol challenge session

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 A118G

Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. --- A118G ---

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. --- A118G ---

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. --- A118G ---


2 N40D

Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. --- A118G --- --- Asn40Asp ---



HPO Nodes