An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial.
Maria Karekla, Stella Nicoleta Savvides, Andrew Gloster
https://pubmed.ncbi.nlm.nih.gov/32383736Actively Recruiting
Age: 18Years - 60Years
All Genders
ID06471387
Exploring the Genetic and Molecular Underpinning of Nicotine Addiction for the Development of New Therapeutic Strategies
Led by University of Cyprus · Updated on 2024-06-25
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the genetic and molecular causes of nicotine addiction to find new potential treatments. This case-control study uses genetic epidemiology and molecular biology techniques to identify drug targets for smoking cessation and examines how DNA methylation of these genes relates to quitting motivation, addiction severity, and relapse risk. The study also explores possible gender differences in these biological factors. Participants in the study will include 200 current daily cigarette smokers aged 18 to 60, who will take part in a 6-week, once-weekly, self-delivered computerized smoking cessation program called Flexiquit. This avatar-led app supports quitting efforts and tracks progress through personalized modules. Participants will be grouped as abstainers if they maintain verified abstinence for 6 months or relapsers if they return to smoking. During the study, researchers will collect biofluids before cessation to analyze DNA methylation patterns. They will assess associations between gene methylation and nicotine dependence, motivation to quit, and relapse vulnerability at baseline and at 3 and 6 months after quitting. The study will measure novel drug targets through Mendelian randomization and monitor gender-specific methylation effects. The total participation includes initial assessment and follow-up over 6 months.
CONDITIONS
Brief Title
Unraveling the Genetic Basis of Nicotine Addiction for Novel Therapeutic Strategies
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18-60 years old
- Current daily cigarette smoker
- Able to understand study procedures and provide informed consent
- For females, non-pregnant and non-lactating
You will not qualify if you...
- Significant uncontrolled medical conditions (e.g. cardiovascular disease, respiratory disorders, cancer) that could affect smoking behaviors or study participation
- Major uncontrolled psychiatric disorders (e.g. schizophrenia, bipolar disorder, severe depression)
- Current substance use disorder (except nicotine dependence)
- Taking medications that could interfere with study objectives (e.g. medications for smoking cessation)
- Significant cognitive impairment preventing completion of study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 6 weeks
Participants engage in a 6-week, once weekly self-delivered computerized smoking cessation program called Flexiquit, which supports abstinence and monitors progress through personalized modules and assessments.
Weekly visits for 6 weeks
Long-term Monitoring
Duration - Up to 6 months post cessation
Participants are monitored for smoking abstinence and relapse vulnerability with assessments of motivation, nicotine dependence, and DNA methylation at 3 and 6 months after nicotine cessation to identify epigenetic biomarkers and gender differences.
2 visits (at 3 and 6 months post cessation)
Trial Site Locations
Total: 1 location
1
Center for Applied Neuroscience (CAN)
Nicosia, Cyprus, 2100
Actively Recruiting
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Research Team
A
Andrea N Georgiou, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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