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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: 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

• Registration Number: NCT03185546
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2018-08-06
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2021-04
• Results First Submitted: 2021-04-14
• Results First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Results First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors	Tobacco Flavors	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor	Tobacco Flavors	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors	Moderate nicotine level e-liquid	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC cigarette + low nicotine e-liquid + tobacco flavors	NNC Spectrum Cigarette	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC cigarette + low nicotine e-liquid + tobacco flavors	Low nicotine level e-liquid	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC cigarette + low nicotine e-liquid + variety flavors	Low nicotine level e-liquid	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC cigarette + moderate nicotine e-liquid + variety flavors	NNC Spectrum Cigarette	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC cigarette + moderate nicotine e-liquid + variety flavors	Tobacco and non-tobacco e-liquid flavors	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC cigarette + low nicotine e-liquid + variety flavors	NNC Spectrum Cigarette	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC cigarette + low nicotine e-liquid + variety flavors	Tobacco and non-tobacco e-liquid flavors	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC cigarette + low nicotine e-liquid +tobacco flavors	VLNC Spectrum Cigarette	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC cigarette + low nicotine e-liquid +tobacco flavors	Tobacco Flavors	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC cigarette + low nicotine e-liquid + variety flavors	Tobacco and non-tobacco e-liquid flavors	Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC cigarette + low nicotine e-liquid + tobacco flavors	Tobacco Flavors	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC cigarette + moderate nicotine e-liquid + variety flavors	Moderate nicotine level e-liquid	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC cigarette + moderate nicotine e-liquid + variety flavors	Tobacco and non-tobacco e-liquid flavors	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors	NNC Spectrum Cigarette	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC cigarette + moderate nicotine e-liquid + variety flavors	Moderate nicotine level e-liquid	Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor	VLNC Spectrum Cigarette	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor	Moderate nicotine level e-liquid	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC cigarette + low nicotine e-liquid + variety flavors	Low nicotine level e-liquid	Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC cigarette + moderate nicotine e-liquid + variety flavors	VLNC Spectrum Cigarette	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC cigarette + low nicotine e-liquid + variety flavors	VLNC Spectrum Cigarette	Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC cigarette + low nicotine e-liquid +tobacco flavors	Low nicotine level e-liquid	Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.

Primary Outcome Measures

Name	Time	Method
Total Cigarettes Smoked Per Day	Week 10 through Week 12	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).

Secondary Outcome Measures

Name	Time	Method
Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)	Baseline - Week 12	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).
Number of Subjects With Smoke Free Days	Baseline-Week 12	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.

Trial Locations

Locations (2)

Wake Forest Biotech Place; 🇺🇸 Winston-Salem, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States