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

Nicotine Dependence Clinical Trial

— ECIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433015
• Other study ID #: 2014-004-00
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: June 27, 2017
• Start date: January 2015
• Est. completion date: September 24, 2016

Study information

• Verified date: June 2017
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 24, 2016
• Est. primary completion date: September 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Other:
• Electronic Cigarette
eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution
• Tobacco Cigarette
Smoke own brand of cigarette as previously

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in overall levels of peripheral inflammatory cytokines	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.	2-8 weeks
Secondary	Change in cotinine levels	Change in serum cotinine levels between study visits two and three.	2-8 weeks
Secondary	Frequency of Electronic Cigarette use	Daily use of electronic cigarette between study visits two and three.	2-8 weeks
Secondary	Change in exhaled Carbon Monoxide	Change in exhaled Carbon Monoxide between study visits two and three.	2-8 weeks
Secondary	Frequency of Tobacco Cigarette use	Average number of tobacco cigarettes smoked between study visits two and three.	2-8 weeks
Secondary	Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI	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.	2-8 weeks
Secondary	Change in BOLD fMRI response during interoception	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.	2-8 weeks
Secondary	Change in BOLD fMRI response to food pictures	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.	2-8 weeks