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

Primary Purpose

Tobacco Smoking, Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Cigarette
Tobacco Cigarette
Sponsored by
Laureate Institute for Brain Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Smoking focused on measuring Electronic Cigarette

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tobacco Cigarette Group

Electronic Cigarette Group

Arm Description

This group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously.

This group will receive an electronic cigarette to use for the duration of the study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in cotinine levels
Change in serum cotinine levels between study visits two and three.
Frequency of Electronic Cigarette use
Daily use of electronic cigarette between study visits two and three.
Change in exhaled Carbon Monoxide
Change in exhaled Carbon Monoxide between study visits two and three.
Frequency of Tobacco Cigarette use
Average number of tobacco cigarettes smoked between study visits two and three.
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.
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.
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.

Full Information

First Posted
April 24, 2015
Last Updated
June 27, 2017
Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT02433015
Brief Title
Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
Acronym
ECIG
Official Title
Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 24, 2016 (Actual)
Study Completion Date
September 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking, Nicotine Dependence
Keywords
Electronic Cigarette

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tobacco Cigarette Group
Arm Type
Active Comparator
Arm Description
This group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously.
Arm Title
Electronic Cigarette Group
Arm Type
Experimental
Arm Description
This group will receive an electronic cigarette to use for the duration of the study.
Intervention Type
Other
Intervention Name(s)
Electronic Cigarette
Intervention Description
eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution
Intervention Type
Other
Intervention Name(s)
Tobacco Cigarette
Intervention Description
Smoke own brand of cigarette as previously
Primary Outcome Measure Information:
Title
Change in overall levels of peripheral inflammatory cytokines
Description
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.
Time Frame
2-8 weeks
Secondary Outcome Measure Information:
Title
Change in cotinine levels
Description
Change in serum cotinine levels between study visits two and three.
Time Frame
2-8 weeks
Title
Frequency of Electronic Cigarette use
Description
Daily use of electronic cigarette between study visits two and three.
Time Frame
2-8 weeks
Title
Change in exhaled Carbon Monoxide
Description
Change in exhaled Carbon Monoxide between study visits two and three.
Time Frame
2-8 weeks
Title
Frequency of Tobacco Cigarette use
Description
Average number of tobacco cigarettes smoked between study visits two and three.
Time Frame
2-8 weeks
Title
Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI
Description
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.
Time Frame
2-8 weeks
Title
Change in BOLD fMRI response during interoception
Description
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.
Time Frame
2-8 weeks
Title
Change in BOLD fMRI response to food pictures
Description
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.
Time Frame
2-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William K Simmons, Ph.D
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

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

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