Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Nicotine Dependence
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

Objective: To develop a neuroimaging/genetic/epigenetic biomarker of nicotine dependence severity that may be useful in predicting success in smoking cessation and in development of new smoking cessation treatment targets. Study population: Four groups will be studied: target group of treatment seek...

Objective: To develop a neuroimaging/genetic/epigenetic biomarker of nicotine dependence severity that may be useful in predicting success in smoking cessation and in development of new smoking cessation treatment targets. Study population: Four groups will be studied: target group of treatment seeking smokers; nontreatment seeking current smokers; never smokers and former smokers. We estimate that we will need n=50/group completers to have sufficient power to develop the brain/genetics biomarkers. Design: This study consists of a 4 group between/within subject design. The experimental group will proceed in 4 phases: Baseline (scan 1), peak withdrawal (scan 2), stable on e-cigarettes (scan 3), and complete abstinence (scans 4-6). Counseling will start after the first scan session and will generally continue weekly until scan 4 (about 12 weeks). After scan 4, therapeutic support will be provided at least monthly via phone until completion of the protocol. The non-treatment seeking smoker comparison group will be scanned twice; at baseline (scan 1) and at peak withdrawal (scan 2). Each of the non-smoking comparison groups (non- and Ex-smokers) will be scanned only at baseline (scan 1). Genetic and epigenetic markers will be obtained in all groups. Outcome measures: Network and multivariate pattern analysis, behavior on a decision making task and task based and resting state blood oxygen level-dependent (BOLD) activation in neural circuits relevant to nicotine addiction during fMRI scanning. Secondary outcomes include BOLD response comparisons between e-cigarettes and smoking and genetic markers of nicotine addiction and relapse susceptibility.

Tracking Information

NCT #
NCT01867411
Collaborators
Not Provided
Investigators
Principal Investigator: Elliot Stein, Ph.D. National Institute on Drug Abuse (NIDA)