Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136, United States
NCT Number: NCT02433015
The objective of this study is to examine the cognitive, immunological, and neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes. The central hypothesis of this study is that this transition will be accompanied by a decrease in peripheral inflammation, which will lead to significant changes in the neurocircuitry underlying interoception and appetite.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Tulsa, Oklahoma, 74136, United States
Participants who are current cigarette smokers will be randomly assigned to either the experimental or control groups. Following a baseline psychiatric assessment session, subjects will return to the study center for two to three additional follow-up visits.
During the second visit, all subjects will undergo a functional magnetic resonance imaging (fMRI) scanning session, during which they will perform a series of functional neuroimaging tasks designed to examine the neural substrates involved in visceral interoception and eating behavior. Prior to the start of the scan session, blood samples will be collected from each subject, for the measurement of bio-markers related to nicotine use and peripheral inflammation. After the end of the second visit, subjects within the experimental group will be asked to switch from combustible to electronic cigarettes. Subjects within the control group will continue to smoke combustible cigarettes as previously.
During the third visit, which will follow two to eight weeks after the second visit, all subjects will provide a second blood sample and complete a second fMRI scan session. Both groups of participants will complete the same fMRI tasks as they did during the second visit.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution
Smoke own brand of cigarette as previously
Time frame: 2-8 weeks
A composite measure of change in overall blood serum levels of multiple peripheral cytokines (CRP, TNF-alpha, sVCAM, IL-1RA, IL-6) between study visits two and three.
Time frame: 2-8 weeks
Change in serum cotinine levels between study visits two and three.
Time frame: 2-8 weeks
Daily use of electronic cigarette between study visits two and three.
Time frame: 2-8 weeks
Change in exhaled Carbon Monoxide between study visits two and three.
Time frame: 2-8 weeks
Average number of tobacco cigarettes smoked between study visits two and three.
Time frame: 2-8 weeks
Difference in resting-state functional connectivity between brain regions, measured by z-scores of correlated spontaneous fluctuations of the BOLD fMRI signal, between study visits two and three.
Time frame: 2-8 weeks
Difference in the brain's hemodynamic response during a task of interoceptive attention to visceral signals, measured by percent change of the BOLD fMRI signal, between study visits two and three.
Time frame: 2-8 weeks
Difference in the brain's hemodynamic response to viewing pictures of appetizing food, measured by percent change of the BOLD fMRI signal, between study visits two and three.
Laureate Institute for Brain Research, Inc.
Other
Acronym: ECIG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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