Clinical trial NCT03861078: The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Official title: The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
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: 2019-03-04
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.


Eligibility criteria: Inclusion Criteria-- Participants must be:

* Healthy (determined by self-report)
* Between the ages of 21-55 years old
* Current cigarette smokers
* Wiling to provide informed consent
* Able to attend the lab session and abstain from tobacco/nicotine products as required
* Agree to use designated products according to the 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: Plasma Nicotine Concentration
timeFrame: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).
measure: Progressive Ratio Task - Breakpoint
timeFrame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
measure: Progressive Ratio Task - Number of Puffs
timeFrame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
measure: Progressive Ratio Task - Latency
timeFrame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Secondary outcomes:
measure: Puff Volume
timeFrame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
measure: Puff Duration
timeFrame: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.
Other outcomes:
measure: Hughes-Hatsukami Questionnaire
timeFrame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
measure: Positive and Negative Affect Schedule
timeFrame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
measure: Drug Effects Questionnaire
timeFrame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
measure: Heart Rate
timeFrame: Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 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.
Locations:
city: Richmond
country: United States
facility: Clinical Behavioral Pharmacology Laboratory
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: STUDY_DIRECTOR
References: