SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02026011

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Optimizing Naltrexone for Individuals of East Asian Descent

This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene on biobehavioral and neural markers of response to naltrexone in individuals of East Asian descent, an ethnic group most likely to express the positive predictive allele.

NCT02026011 Alcohol Use Disorder
MeSH: Alcohol Drinking Alcoholism

2 Interventions

Name: Naltrexone

Description: Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors

Type: Drug

Naltrexone

Name: Placebo

Description: Sugar pill, matched to the active study medication in capsule size and color

Type: Drug

Sugar pill


Primary Outcomes

Description: Biphasic Alcohol Effects Scale (BAES) Alcohol Urge Questionnaire (AUQ)

Measure: Subjective Effects of Alcohol

Time: During the alcohol administration and observation period which is expected to last a total of 4 hours

Description: Alcohol taste cues task for fMRI

Measure: Neural response to alcohol cues

Time: During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes

Secondary Outcomes

Description: Time to first drink and total number of drinks are the primary outcome variables for the alcohol self-administration task

Measure: Alcohol self-administration

Time: Alcohol self-administration period will last 2 hours

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 2 SNPs

SNPs


1 A118G

Inclusion Criteria: - current (i.e., past month) alcohol dependence - East Asian ethnicity (i.e., Chinese, Korean, or Japanese) - Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to allow for balanced groups on all three genotypes (AA, AG, GG) Exclusion Criteria: - lifetime DSM-IV of drug dependence (other than alcohol or nicotine) - current use of psychoactive drugs as determined by self-reports and verified using toxicology testing - lifetime diagnosis of bipolar disorder or any psychotic disorder - contraindications to an MRI scan (including left handedness) Inclusion Criteria: - current (i.e., past month) alcohol dependence - East Asian ethnicity (i.e., Chinese, Korean, or Japanese) - Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to allow for balanced groups on all three genotypes (AA, AG, GG) Exclusion Criteria: - lifetime DSM-IV of drug dependence (other than alcohol or nicotine) - current use of psychoactive drugs as determined by self-reports and verified using toxicology testing - lifetime diagnosis of bipolar disorder or any psychotic disorder - contraindications to an MRI scan (including left handedness) Alcohol Use Disorder Alcohol Drinking Alcoholism Recent pharmacogenetic studies have advanced the gene coding for µ-opioid receptors (OPRM1) gene as a potential moderator of responses to naltrexone. --- A118G ---

Inclusion Criteria: - current (i.e., past month) alcohol dependence - East Asian ethnicity (i.e., Chinese, Korean, or Japanese) - Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to allow for balanced groups on all three genotypes (AA, AG, GG) Exclusion Criteria: - lifetime DSM-IV of drug dependence (other than alcohol or nicotine) - current use of psychoactive drugs as determined by self-reports and verified using toxicology testing - lifetime diagnosis of bipolar disorder or any psychotic disorder - contraindications to an MRI scan (including left handedness) Inclusion Criteria: - current (i.e., past month) alcohol dependence - East Asian ethnicity (i.e., Chinese, Korean, or Japanese) - Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to allow for balanced groups on all three genotypes (AA, AG, GG) Exclusion Criteria: - lifetime DSM-IV of drug dependence (other than alcohol or nicotine) - current use of psychoactive drugs as determined by self-reports and verified using toxicology testing - lifetime diagnosis of bipolar disorder or any psychotic disorder - contraindications to an MRI scan (including left handedness) Alcohol Use Disorder Alcohol Drinking Alcoholism Recent pharmacogenetic studies have advanced the gene coding for µ-opioid receptors (OPRM1) gene as a potential moderator of responses to naltrexone. --- A118G --- --- A118G ---


2 N40D

Naltrexone for Individuals of East Asian Descent This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene on biobehavioral and neural markers of response to naltrexone in individuals of East Asian descent, an ethnic group most likely to express the positive predictive allele. --- Asn40Asp ---

The most widely studied polymorphism of the OPRM1 gene is the Asn40Asp single nucleotide polymorphism (SNP), a functional mutation thought to affect receptor activity such that the Asp40 variant binds β-endorphin three times stronger than the Asn40 allele. --- Asn40Asp ---

This pilot study also found support for a gene dose-response, such that Asp40Asp individuals showed greater NTX responsivity than those with the Asn40Asp genotype. --- Asn40Asp ---

This study seeks to build upon these preliminary findings by testing heavy drinkers of East Asian descent across three OPRM1 genotypes (Asn40Asn, n = 30; Asn40Asp, n = 30, and Asp40Asp, n = 30). --- Asn40Asp ---

This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene on biobehavioral and neural markers of response to naltrexone in individuals of Asian descent, an ethnic group most likely to express the positive predictive allele (Asp40). --- Asn40Asp ---



HPO Nodes