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

Study Overview
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Brief Summary
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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.

Official Title
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Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior

Conditions
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Smoking

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors<br>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. | Other: NNC Spectrum Cigarette<br>* Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.<br>Other: Moderate nicotine level e-liquid<br>* Participants are provided with moderate nicotine level e-liquid for 13 weeks<br>Other: Tobacco Flavors<br>* Participants can choose e-liquid flavors from a selection of tobacco flavors<br>|
| Experimental: NNC cigarette + low nicotine e-liquid + tobacco flavors<br>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. | Other: NNC Spectrum Cigarette<br>* Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.<br>Other: Low nicotine level e-liquid<br>* Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks<br>Other: Tobacco Flavors<br>* Participants can choose e-liquid flavors from a selection of tobacco flavors<br>|
| Experimental: NNC cigarette + moderate nicotine e-liquid + variety flavors<br>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. | Other: NNC Spectrum Cigarette<br>* Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.<br>Other: Moderate nicotine level e-liquid<br>* Participants are provided with moderate nicotine level e-liquid for 13 weeks<br>Other: Tobacco and non-tobacco e-liquid flavors<br>* Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices<br>|
| Experimental: NNC cigarette + low nicotine e-liquid + variety flavors<br>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 | Other: NNC Spectrum Cigarette<br>* Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.<br>Other: Low nicotine level e-liquid<br>* Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks<br>Other: Tobacco and non-tobacco e-liquid flavors<br>* Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices<br>|
| Experimental: Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor<br>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. | Other: VLNC Spectrum Cigarette<br>* Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks<br>Other: Moderate nicotine level e-liquid<br>* Participants are provided with moderate nicotine level e-liquid for 13 weeks<br>Other: Tobacco Flavors<br>* Participants can choose e-liquid flavors from a selection of tobacco flavors<br>|
| Experimental: VLNC cigarette + low nicotine e-liquid +tobacco flavors<br>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. | Other: VLNC Spectrum Cigarette<br>* Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks<br>Other: Low nicotine level e-liquid<br>* Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks<br>Other: Tobacco Flavors<br>* Participants can choose e-liquid flavors from a selection of tobacco flavors<br>|
| Experimental: VLNC cigarette + moderate nicotine e-liquid + variety flavors<br>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. | Other: VLNC Spectrum Cigarette<br>* Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks<br>Other: Moderate nicotine level e-liquid<br>* Participants are provided with moderate nicotine level e-liquid for 13 weeks<br>Other: Tobacco and non-tobacco e-liquid flavors<br>* Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices<br>|
| Experimental: VLNC cigarette + low nicotine e-liquid + variety flavors<br>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 | Other: VLNC Spectrum Cigarette<br>* Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks<br>Other: Low nicotine level e-liquid<br>* Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks<br>Other: Tobacco and non-tobacco e-liquid flavors<br>* Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week 10 through Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline-Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, vaping