Smoking is a difficult habit to quit, and some people find it more difficult to quit than
others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine
changes some patterns of brain activity, and smokers have differences in brain activity when
compared to non-smokers. Some genes make it more likely that a person will become addicted to
smoking. Researchers want to study how nicotine interacts with genes and brain activity. This
may help develop better treatments to help people quit smoking.
To develop a test of nicotine dependence, using brain activity and genetic analysis, which
may be useful in predicting success in smoking cessation and in the development of new
smoking cessation treatment targets.
Main group: Current smokers between 18 and 55 years of age who are seeking treatment to
Comparison group: Current smokers between 18 and 55 years of age who are not seeking to
Comparison group: Healthy former smokers between 18 and 55 years of age.
Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age.
Participants will be screened with a physical exam and medical history. Blood samples
will be collected.
The three comparison groups will have one magnetic resonance imaging (MRI) scan session.
They will have tests of thinking, concentration, and memory both inside the scanner, and
while sitting in front of a computer.
Current smokers who are trying to quit must be willing to undergo a course of nicotine
treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants
will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They
will do thinking, concentration, and memory tasks inside and outside of the scanner.
For smokers, the first scanning session will take place before they attempt to quit.
This will be a baseline scan. The second scanning session will take place 48 hours after
having their last real cigarette. After this scan, they will use electronic cigarettes
to help quit their habit.
After using e-cigarettes for two weeks, smokers will have a third scan session.. They
will then gradually taper their use of the electronic cigarettes over the course of
three weeks, at which point they will be nicotine abstinent.
After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will
be approximately 6 months after start of the study, and the final scan will take place
at about 1 year from the study start.
Smokers will continue to receive support on quitting smoking until the study ends at
about 1 year.
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. Further, by evaluating those who vape nicotine,
findings will determine whether biomarkers differ between those who smoke or vape, allowing
for the development of cessation
strategies that relate to preferred nicotine delivery.
Study population: Four groups will be studied: target group of treatment seeking
smokers/vapers; nontreatment seeking current smokers/vapers; never smokers/never vapers and
former smokers. We estimate that we will need n=50/subgroup 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
nicotine replacement (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
seeker comparison group will be scanned twice; at baseline (scan 1) and at peak withdrawal
(scan 2). Each of the non-nicotine user comparison groups (non-nicotine users and Ex-smokers)
will be scanned only at baseline (scan 1). Genetic and epigenetic markers will be obtained in
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 nicotine replacement and typical nicotine use and
genetic markers of nicotine addiction and relapse susceptibility.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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