Clinical trial NCT02433015: Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
Official title: Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Nicotine Dependence
Keywords: Electronic Cigarette
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2015-05-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in overall levels of peripheral inflammatory cytokines
timeFrame: 2-8 weeks
Secondary outcomes:
measure: Change in cotinine levels
timeFrame: 2-8 weeks
measure: Frequency of Electronic Cigarette use
timeFrame: 2-8 weeks
measure: Change in exhaled Carbon Monoxide
timeFrame: 2-8 weeks
measure: Frequency of Tobacco Cigarette use
timeFrame: 2-8 weeks
measure: Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI
timeFrame: 2-8 weeks
measure: Change in BOLD fMRI response during interoception
timeFrame: 2-8 weeks
measure: Change in BOLD fMRI response to food pictures
timeFrame: 2-8 weeks
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: William K Simmons, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: