SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00817089

Developed by Shray Alag, 2019.
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 will combine two inpatient alcohol challenge sessions along with 12 weeks of outpatient treatment using random assignment to either naltrexone or placebo.

NCT00817089 Alcoholism
MeSH: Alcoholism

3 Interventions

Name: naltrexone

Description: phase 1: 30 or 50 mg of naltrexone prior to challenge session; phase 2: 50mg/day for 12 weeks

Type: Drug

P1A P2A

Name: placebo

Description: placebo pills

Type: Drug

P1B P2B

Name: alcohol

Description: 190 proof alcohol prepared to 11% volume mixed with fruit juice

Type: Other

P1A P1B


Primary Outcomes

Measure: Differences between the peak cortisol response (and subjective response) of all individuals including those with different genetic markers, during the naltrexone-alcohol session, subjective response as measured by Biphasic Alcohol Effects Scale.

Time: during challenge sessions

Secondary Outcomes

Measure: Improvement in quality of life (MOS SF-12), alternative drinking measures, biological markers of heavy drinking (CDT and GGT)

Time: 12 weeks

Measure: Asp40 gene variant and family history of alcohol problems.

Time: once

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