Skip to main content
OpenTrials
Completed

NCT Number: NCT02433015

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • current cigarette smokers who have smoked for at least one year
  • right-handed adults
  • able to provide written informed consent

Exclusion criteria

  • use of anticonvulsant, stimulant, or antipsychotic medication for 3 weeks prior to scanning
  • any medical conditions or medications likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases
  • any history of drug (other than nicotine) or alcohol abuse within 1 year
  • current pregnancy or breast feeding
  • primary language other than English
  • meeting general MRI exclusion criteria such as magnetic implants or claustrophobia
  • Past history of any axis I psychiatric condition, other than major depressive disorder and post-traumatic stress disorder
  • Current major depression or post-traumatic stress disorder
  • Serious suicidal ideation

Treatment and study plan

Electronic Cigarette

Other

eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution

Tobacco Cigarette

Other

Smoke own brand of cigarette as previously

Primary outcomes

  1. Change in overall levels of peripheral inflammatory cytokines

    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.

Secondary outcomes

  1. Change in cotinine levels

    Time frame: 2-8 weeks

    Change in serum cotinine levels between study visits two and three.

  2. Frequency of Electronic Cigarette use

    Time frame: 2-8 weeks

    Daily use of electronic cigarette between study visits two and three.

  3. Change in exhaled Carbon Monoxide

    Time frame: 2-8 weeks

    Change in exhaled Carbon Monoxide between study visits two and three.

  4. Frequency of Tobacco Cigarette use

    Time frame: 2-8 weeks

    Average number of tobacco cigarettes smoked between study visits two and three.

  5. Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI

    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.

  6. Change in BOLD fMRI response during interoception

    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.

  7. Change in BOLD fMRI response to food pictures

    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.

Sponsors and collaborators

Lead sponsor

Laureate Institute for Brain Research, Inc.

Other

Collaborators

  • University of Oklahoma

Registry information

Acronym: ECIG

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 4, 2015
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.