Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471387
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Unraveling the Genetic Basis of Nicotine Addiction for Novel Therapeutic Strategies
Sponsor:
University of Cyprus
Organization:
University of Cyprus
Study Overview
Official Title:
Exploring the Genetic and Molecular Underpinning of Nicotine Addiction for the Development of New Therapeutic Strategies
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NicoGen
Brief Summary:
This case-control study aims to investigate the genetic and molecular bases of nicotine addiction to identify potential therapeutic targets The project will involve drug repurposing using Mendelian Randomization a smoking cessation intervention and the analysis of methylation status in participants undergoing nicotine withdrawal
Detailed Description:
Cigarette smoking remains the largest preventable risk factor for chronic diseases and premature mortality worldwide While several medications have been approved to aid smoking cessation most individuals relapse following an initial period of abstinence with only around 15 achieving long-term abstinence beyond 6-12 months This highlights a critical need to identify novel drug targets and develop more effective pharmacotherapies to treat nicotine addiction and maintain long-term smoking abstinence
The proposed case-control study aims to leverage an interdisciplinary approach combining genetic epidemiology and molecular biology to 1 Identify potential novel druggable targets for smoking cessation using a drug repurposing Mendelian randomization MR strategy and 2 Assess whether epigenetic modifications DNA methylation of the identified drug target genes are associated with motivation to quit smoking nicotine dependence severity and vulnerability to smoking relapse following a cessation attempt
Specifically NicoGen study utilizes large-scale genomic datasets of expression quantitative trait loci eQTLs and protein quantitative trait loci pQTLs to identify genetic variants that influence expressionlevels of genes encoding druggable proteins targets of approved drugsclinical candidates MR analyses will then determine if genetically-predicted expression of these genes is causally related to smoking cessation outcomes
Additionally 200 current cigarette smokers 100 men 100 women will be recruited prior to smoking cessation for collection of biofluids for DNA extraction
The methylation levels of the top candidate drug target genes identified in will be assessed and compared between 1 Cases who achieve 6 month abstinence vs relapsed controls 2 High vs low motivation to quit groups and 3 High vs low nicotine dependence groups This allows identification of epigenetic biomarkers predictive of cessation outcomes
Additionally potential gender differences in the associations between gene methylation motivation dependence and relapse vulnerability will be explored to identify gender-specific drug targets
The proposed case-control study aims to leverage an interdisciplinary approach combining genetic epidemiology and molecular biology to 1 Identify potential novel druggable targets for smoking cessation using a drug repurposing Mendelian randomization MR strategy and 2 Assess whether epigenetic modifications DNA methylation of the identified drug target genes are associated with motivation to quit smoking nicotine dependence severity and vulnerability to smoking relapse following a cessation attempt
Specifically NicoGen study utilizes large-scale genomic datasets of expression quantitative trait loci eQTLs and protein quantitative trait loci pQTLs to identify genetic variants that influence expressionlevels of genes encoding druggable proteins targets of approved drugsclinical candidates MR analyses will then determine if genetically-predicted expression of these genes is causally related to smoking cessation outcomes
Additionally 200 current cigarette smokers 100 men 100 women will be recruited prior to smoking cessation for collection of biofluids for DNA extraction
The methylation levels of the top candidate drug target genes identified in will be assessed and compared between 1 Cases who achieve 6 month abstinence vs relapsed controls 2 High vs low motivation to quit groups and 3 High vs low nicotine dependence groups This allows identification of epigenetic biomarkers predictive of cessation outcomes
Additionally potential gender differences in the associations between gene methylation motivation dependence and relapse vulnerability will be explored to identify gender-specific drug targets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Onisilos-co-fund182 | OTHER_GRANT | None | None |