N/A N=50 Randomized Double-blind Prevention

Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

Smoking

Bottom Line

View on ClinicalTrials.gov: NCT03185546 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

May 2021

Primary outcome: Primary: Total Cigarettes Smoked Per Day — 21.6; 7.7; 18.4; 12.5 number of cigarettes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NNC Spectrum Cigarette (Other); VLNC Spectrum Cigarette (Other); Moderate nicotine level e-liquid (Other); Low nicotine level e-liquid (Other); Tobacco Flavors (Other); Tobacco and non-tobacco e-liquid flavors (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Cigarettes Smoked Per Day	21.6; 7.7; 18.4; 12.5; 34; 18.7	—
SECONDARY Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)	31; 7.2; 18; 12; 18.2; 21	—
SECONDARY Number of Subjects With Smoke Free Days	1; 1; 3; 3; 4; 3	—

Summary

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

Eligibility Criteria

Inclusion Criteria

Smokers who have tried vaping multiple times.
Generally good health.

Exclusion Criteria

If female, currently pregnant, trying to become pregnant or breastfeeding.
Planning to quit smoking.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03185546). 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.