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

Wake Forest University Health Sciences156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

156

Conditions

Smoking

Interventions

Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

VLNC Spectrum CigaretteOTHER

Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

Moderate nicotine level e-liquidOTHER

Participants are provided with moderate nicotine level e-liquid for 13 weeks

Low nicotine level e-liquidOTHER

Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

Tobacco FlavorsOTHER

Participants can choose e-liquid flavors from a selection of tobacco flavors

Tobacco and non-tobacco e-liquid flavorsOTHER

Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Wake Forest Biotech Place

Winston-Salem, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Total Cigarettes Smoked Per Day

The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).

Time frame: Week 10 through Week 12

Secondary Outcomes

Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)

Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm).

Time frame: Baseline - Week 12

Number of Subjects With Smoke Free Days

Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study.

Time frame: Baseline-Week 12

Data from ClinicalTrials.gov

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