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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02433015
Study type Interventional
Source Laureate Institute for Brain Research, Inc.
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date September 24, 2016

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