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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking; Nicotine Dependence
• Intervention / Treatment: Other: Tobacco Cigarette; Other: Electronic Cigarette

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tobacco Cigarette Group; This group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously.	Other: Tobacco Cigarette; Smoke own brand of cigarette as previously
Experimental: Electronic Cigarette Group; This group will receive an electronic cigarette to use for the duration of the study.	Other: Electronic Cigarette; eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cotinine levels	Change in serum cotinine levels between study visits two and three.	2-8 weeks
Frequency of Electronic Cigarette use	Daily use of electronic cigarette between study visits two and three.	2-8 weeks
Change in exhaled Carbon Monoxide	Change in exhaled Carbon Monoxide between study visits two and three.	2-8 weeks
Frequency of Tobacco Cigarette use	Average number of tobacco cigarettes smoked between study visits two and three.	2-8 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborators: University of Oklahoma
• Investigators: Principal Investigator: William K Simmons, Ph.D, Laureate Institute for Brain Research

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 24, 2016
• Study Completion (Actual): September 24, 2016

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): May 4, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Electronic Cigarette
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 2014-004-00