Clinical trial NCT04378907: Assessing Electronic Cigarette Nicotine Flux
Official title: Assessing Electronic Cigarette Nicotine Flux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.


Eligibility criteria: Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 18-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Primary outcomes:
measure: Plasma Nicotine Concentration
timeFrame: Approximately 205 minutes
measure: Cigarette Challenge Paradigm
timeFrame: This task will occur at approximiately 200 minutes until 205 minutes
Secondary outcomes:
measure: Puff volume
timeFrame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
measure: Puff duration
timeFrame: Puff duration will be measured during the approximately 5-minute, 10-puff use bout.
Other outcomes:
measure: Change in heart rate
timeFrame: Baseline to 255 minutes
measure: Inter puff interval
timeFrame: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.
measure: Flow rate
timeFrame: Flow rate will be measured during the approximately 5-minute, 10-puff use bout.
measure: Direct Effects of Vaping Questionnaire
timeFrame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
measure: Direct Effects of Nicotine Questionnaire
timeFrame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
measure: Hughes-Hatsukami Questionnaire
timeFrame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
measure: General Labeled Magnitude Scale
timeFrame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
measure: Labeled Hedonic Scale
timeFrame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Locations:
city: Richmond
country: United States
facility: Center for the Study of Tobacco Products
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: STUDY_DIRECTOR
References: