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Report for Clinical Trial NCT01050400
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
The purpose of this study is to determine if non-invasive salivary genetic screening of
breastfeeding mothers taking codeine will allow for the successful identification of
mother-infant pairs susceptible to adverse events and to prevent these adverse events by
personalizing their medication to their genetics.
Name: Cytochrome P450 2D6 (CYP2D6) genetic screening.
Description: Genetic screening for cytochrome P450 2D6 (CYP2D6) polymorphism will be conducted on genetic information obtained from non-invasive salivary samples.
Group Labels: 2 Observant Prospective CYP2D6 genetic screening
Primary Outcomes Measure: Incidence of maternal and neonatal CNS depression in the prospective pharmacogenetic screening group to that of a retrospectively screened population Time: 5-8 days post c-section surgery
Secondary Outcomes Measure: Incidence of the phase II uridine diphosphate glucuronyltransferase 2B7 (UGT2B7)*2/*2 variant which has been associated with higher morphine 6-glucuronide to morphine ratios. Time: Minimum 1 week prior to c-section
Measure: Incidence of the C3435T polymorphism in the multi-drug resistance gene (MDR1) which has been associated with significantly greater pain relief from morphine treatment. Time: Minimum 1 week prior to c-section
Measure: Incidence of the A118G polymorphism in the opioid receptor 1 (OPRM1) which has been associated with reduced response to morphine treatment. Time: Minimum 1 week prior to c-section
Time Perspective: Prospective
There are 2 SNPs
Incidence of the A118G polymorphism in the opioid receptor 1 (OPRM1) which has been associated with reduced response to morphine treatment.. null. --- A118G ---