Clinical trial NCT03710590: Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
Official title: Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarettes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-10-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.


Eligibility criteria: Inclusion Criteria--participants must be:

* 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.
* Individuals who weigh less than 110 pounds

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: Change in Plasma Nicotine
timeFrame: Baseline to 5 min after the start of a 10-puff product use
measure: Puff Volume
timeFrame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
measure: Puff Duration
timeFrame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Secondary outcomes:
measure: Heart Rate
timeFrame: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes
Other outcomes:
measure: Inter Puff Interval
timeFrame: Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period
measure: Flow Rate
timeFrame: Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period
measure: Hughes-Hatsukami Questionnaire
timeFrame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
measure: Direct Effects of Product Use Questionnaire
timeFrame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.
measure: Direct Effects of Nicotine Questionnaire
timeFrame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
measure: Carbon Monoxide Levels
timeFrame: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
measure: Blood Pressure
timeFrame: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
measure: General Labeled Magnitude Scale
timeFrame: The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.
Locations:
city: Richmond
country: United States
facility: Clinical Behavioral Pharmacolgy Laboratory
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eversole A, Budd S, Karaoghlanian N, Lipato T, Eissenberg T, Breland AB. Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects. Exp Clin Psychopharmacol. 2023 Apr;31(2):443-454. doi: 10.1037/pha0000576. Epub 2022 Jun 13.