Tobacco SmokingECIGNCT02433015
Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
A study testing Electronic Cigarette and Tobacco Cigarette in people with Tobacco Smoking and Nicotine Dependence, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Nicotine Dependence
- What is being tested?
- Electronic Cigarette and Tobacco Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 24 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current cigarette smokers who have smoked for at least one year
- right-handed adults
- able to provide written informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
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.
Read the 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.
- Conditions
- Tobacco Smoking, Nicotine Dependence
- Being tested
- Electronic Cigarette, Tobacco Cigarette
- Keywords
- Electronic Cigarette
- Medical subject headings
- Tobacco Smoking, Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic CigaretteOther
eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution
Tobacco CigaretteOther
Smoke own brand of cigarette as previously
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Cigarette Group | Active comparator | This group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously. Receives: Other: Tobacco Cigarette |
| Electronic Cigarette Group | Experimental | This group will receive an electronic cigarette to use for the duration of the study. Receives: Other: Electronic Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-8 weeks
Secondary outcomes (7)
Change in cotinine levels
Change in serum cotinine levels between study visits two and three.
Measured: 2-8 weeks
Frequency of Electronic Cigarette use
Daily use of electronic cigarette between study visits two and three.
Measured: 2-8 weeks
Change in exhaled Carbon Monoxide
Change in exhaled Carbon Monoxide between study visits two and three.
Measured: 2-8 weeks
Frequency of Tobacco Cigarette use
Average number of tobacco cigarettes smoked between study visits two and three.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJan 2015
- Primary completion24 Sep 2016
- Study completion24 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- William K Simmons, Ph.D, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433015
- Sponsor's protocol ID
- 2014-004-00
- Acronym
- ECIG
- Status last verified
- Jun 2017
- First submitted
- 24 Apr 2015
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
- ClinicalTrials.gov ID
- NCT02433015
- Acronym / sponsor ID
- ECIG / 2014-004-00
- Conditions
- Tobacco Smoking, Nicotine Dependence
- Keywords
- Electronic Cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- Jan 2015
- Primary completion
- 24 Sep 2016 (actual)
- Study completion
- 24 Sep 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco Cigarette Group | Active comparator | Other: Tobacco CigaretteThis group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously. |
| Electronic Cigarette Group | Experimental | Other: Electronic CigaretteThis group will receive an electronic cigarette to use for the duration of the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- current cigarette smokers who have smoked for at least one year
- right-handed adults
- able to provide written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic CigaretteeGo-type electronic cigarette with a supply of 18mg/ml nicotine solution | Other | Electronic Cigarette Group |
| Tobacco CigaretteSmoke own brand of cigarette as previously | Other | Tobacco Cigarette Group |
Primary outcome
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.
7 secondary outcomes
Change in cotinine levels
Time frame: 2-8 weeks
Frequency of Electronic Cigarette use
Time frame: 2-8 weeks
Change in exhaled Carbon Monoxide
Time frame: 2-8 weeks
Frequency of Tobacco Cigarette use
Time frame: 2-8 weeks
Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI
Time frame: 2-8 weeks
Change in BOLD fMRI response during interoception
Time frame: 2-8 weeks
Change in BOLD fMRI response to food pictures
Time frame: 2-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Simmons, Ph.D principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Cigarette and Tobacco Cigarette in people with Tobacco Smoking and Nicotine Dependence, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall levels of peripheral inflammatory cytokines (time frame: 2-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.