N/A N=22 Other

Assessment of Two New Electronic Cigarettes in Cigarette Smokers

Electronic Cigarettes

Bottom Line

View on ClinicalTrials.gov: NCT03435562 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2020

Primary outcome: Primary: Change in Plasma Nicotine — 7.62; 10.65; 18.31; 7.19 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: JUUL electronic cigarette (Other); IQOS electronic cigarette (Other); Own Brand cigarette (Other)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Plasma Nicotine	7.62; 10.65; 18.31; 7.19; 5.97; 12.23	—
SECONDARY Carbon Monoxide Levels	5.2; 5.5; 5.3; 8.7; 5.1; 4.9	—
SECONDARY Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1	24.8; 24.7; 25.1; 13.2; 20.1; 16.0	—
SECONDARY Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2	11.7; 10.3; 12.5; 6.9; 8.1; 6.6	—
SECONDARY Hughes-Hatsukami Questionnaire - Anxious	46.3; 42.8; 44.5; 24.8; 24.4; 28.4	—
SECONDARY Hughes-Hatsukami Questionnaire - Craving	75.2; 70.5; 73.5; 34.9; 49.3; 42.9	—
SECONDARY Hughes-Hatsukami Questionnaire - Depression	21.4; 15.1; 20.5; 9.8; 8.8; 15.1	—
SECONDARY Hughes-Hatsukami Questionnaire - Difficulty Concentrating	28.2; 37.6; 30.0; 18.5; 17.3; 24.4	—
SECONDARY Hughes-Hatsukami Questionnaire - Drowsy	35.2; 33.8; 31.9; 28.7; 21.4; 29.4	—
SECONDARY Hughes-Hatsukami Questionnaire - Hunger	39.9; 43.2; 43.0; 31.9; 35.6; 30.2	—
SECONDARY Hughes-Hatsukami Questionnaire - Impatient	42.1; 41.0; 51.4; 23.9; 25.9; 25.1	—
SECONDARY Hughes-Hatsukami Questionnaire - Irritable	37.4; 34.5; 38.7; 14.9; 18.4; 19.8	—
SECONDARY Hughes-Hatsukami Questionnaire - Restless	40.8; 30.2; 28.9; 19.7; 26.9; 19.7	—
SECONDARY Hughes-Hatsukami Questionnaire - Desire for Sweets	24.2; 27.4; 24.8; 16.8; 20.3; 16.4	—
SECONDARY Hughes-Hatsukami Questionnaire - Urge to Smoke	76.5; 67.2; 74.7; 39.2; 48.8; 46.2	—
SECONDARY Direct Effects of Nicotine Questionnaire - Awake	40.9; 33.8; 36.5; 45.1; 28.1; 34.5	—
SECONDARY Direct Effects of Nicotine Questionnaire - Calm	60.9; 47.9; 54.4; 60.7; 46.6; 43.2	—
SECONDARY Direct Effects of Nicotine Questionnaire - Concentrate	34.8; 24.5; 38.5; 42.0; 27.5; 27.8	—
SECONDARY Direct Effects of Nicotine Questionnaire - Dizzy	40.7; 33.7; 36.4; 30.1; 19.4; 26.9	—
SECONDARY Direct Effects of Nicotine Questionnaire - Reduce Hunger	41.9; 35.2; 29.2; 33.0; 37.1; 34.3	—
SECONDARY Direct Effects of Nicotine Questionnaire - Sick	4.1; 8.1; 9.5; 2.6; 7.8; 10.5	—
SECONDARY Direct Effects of Product Use Questionnaire - Pleasant	81.4; 50.4; 58.8; 81.9; 50.6; 58.9	—
SECONDARY Direct Effects of Product Use Questionnaire - Taste Good	77.7; 50.5; 54.6; 74.0; 51.2; 49.8	—
SECONDARY Direct Effects of Product Use Questionnaire - Satisfying	84.3; 47.0; 58.8; 83.7; 46.5; 58.8	—
SECONDARY Direct Effects of Product Use Questionnaire - Smoke Right Now	62.8; 45.4; 47.2; 44.1; 35.5; 37.5	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03435562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.