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

June 27, 2017 updated by: Laureate Institute for Brain Research, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2-8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in cotinine levels
Time Frame: 2-8 weeks
Change in serum cotinine levels between study visits two and three.
2-8 weeks
Frequency of Electronic Cigarette use
Time Frame: 2-8 weeks
Daily use of electronic cigarette between study visits two and three.
2-8 weeks
Change in exhaled Carbon Monoxide
Time Frame: 2-8 weeks
Change in exhaled Carbon Monoxide between study visits two and three.
2-8 weeks
Frequency of Tobacco Cigarette use
Time Frame: 2-8 weeks
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
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.
2-8 weeks
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.
2-8 weeks
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.
2-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laureate Institute for Brain Research, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oklahoma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William K Simmons, Ph.D, Laureate Institute for Brain Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-004-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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