NCT02433015

Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tobacco Smoking
• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Electronic Cigarette	eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution
OTHER	Tobacco Cigarette	Smoke own brand of cigarette as previously

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-09-24
• Completion: 2016-09-24
• First posted: 2015-05-04
• Last updated: 2017-06-28

Locations

1 site across 1 country: United States