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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-24

Brief Summary

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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.

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Detailed Description

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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

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Tobacco Smoking Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Tobacco Cigarette Group

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

Group Type ACTIVE_COMPARATOR

Tobacco Cigarette

Intervention Type OTHER

Smoke own brand of cigarette as previously

Electronic Cigarette Group

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

Group Type EXPERIMENTAL

Electronic Cigarette

Intervention Type OTHER

eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution

Interventions

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Electronic Cigarette

eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution

Intervention Type OTHER

Tobacco Cigarette

Smoke own brand of cigarette as previously

Intervention Type OTHER

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes