Clinical trial NCT03435562: Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Official title: Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarettes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.


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
* cigarette smokers

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: Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Secondary outcomes:
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: Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
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: Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
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: Hughes-Hatsukami Questionnaire - Anxious
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Craving
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Depression
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Difficulty Concentrating
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Drowsy
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Hunger
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Impatient
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Irritable
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Restless
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Desire for Sweets
timeFrame: Questionnaire will be administered 4 times in 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: Hughes-Hatsukami Questionnaire - Urge to Smoke
timeFrame: Questionnaire will be administered 4 times in 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 Nicotine Questionnaire - Awake
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 Nicotine Questionnaire - Calm
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 Nicotine Questionnaire - Concentrate
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 Nicotine Questionnaire - Dizzy
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 Nicotine Questionnaire - Reduce Hunger
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 Nicotine Questionnaire - Sick
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 - Pleasant
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 approxiamtely 1-hour ad lib use period.
measure: Direct Effects of Product Use Questionnaire - Taste Good
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 approxiamtely 1-hour ad lib use period.
measure: Direct Effects of Product Use Questionnaire - Satisfying
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 approxiamtely 1-hour ad lib use period.
measure: Direct Effects of Product Use Questionnaire - Smoke Right Now
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 approxiamtely 1-hour ad lib use period.
Other outcomes:
measure: Heart Rate
timeFrame: Heat rate will be measured from baseline continuously throughout each each approximately 4-hr session
measure: Blood Pressure
timeFrame: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
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: