Smoking
Conditions
Keywords
smoking, vaping
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.
Interventions
OTHERNNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
OTHERVLNC Spectrum Cigarette
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
OTHERModerate nicotine level e-liquid
Participants are provided with moderate nicotine level e-liquid for 13 weeks
OTHERLow nicotine level e-liquid
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
OTHERTobacco Flavors
Participants can choose e-liquid flavors from a selection of tobacco flavors
OTHERTobacco and non-tobacco e-liquid flavors
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
Sponsors
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mercapturic Acids | Baseline-Week 12 | Measure of toxicant exposure |
| Fagerstrom Nicotine Dependence Scale | Baseline-Week 12 | Dependence Measure |
| Study Cigarettes Smoked Per Day | Baseline-Week 12 | Study cigarettes smoked per day |
| IVR Review and Timeline Followback and E-liquid Accountability | Baseline-Week 12 | Measure of vaping device use |
| Number of Choices to Smoke in Preference Assessment Task | Week 00 | Measure of relative reinforcement |
| Purchase Task | Baseline, Week 12 | Measure of relative reinforcement and substitution |
| Predicted Behavior Questionnaire | Week 12 | Measure of hypothetical cigarette and vaping device use |
| IVR Review and Timeline Followback | Baseline-Week 12 | Measure of compliance |
| Drop-out Rate | Baseline-Week 12 | Drop-out rate |
| Urge to Use Questionnaire | Baseline-Week 12 | Measure of discomfort and dysfunction |
| Center for Epidemiologic Studies Depression Scale | Baseline, Weeks 04, 08, 12 | Measure of discomfort and dysfunction |
| Breath Alcohol | Baseline - Week 12 | Alcohol use |
| Urine Drug Screen | Baseline, Week 12 | Drug use |
| Alcohol Use Questionnaire | Baseline-Week 12 | Alcohol use |
| Drug Use Questionnaire | Baseline-Week 12 | Drug use |
| Weight | Baseline-Week 12 | Weight |
| Minnesota Nicotine Withdrawal Scale | Baseline-Week 12 | Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms. |
| Total Nicotine Equivalents | Baseline - Week 12 | Measure of nicotine exposure |
| Environmental and Social Influences on Tobacco Use Questionnaire | Baseline-Week 12 | Measure of smoking and vaping context |
| Context of Product Use Questionnaire | Baseline-Week 12 | Measure of smoking and vaping context |
| Puff Topography | Weeks 01 and 10 | Measure of smoking and vaping topography |
| Vaping Utility Questionnaire | Baseline, Week 12 | Measure of product expectancy |
| Smoking and Vaping Expectancy Questionnaires | Baseline-Week 12 | Measure of product expectancy |
| Cigarette and Product Evaluation Scale | Baseline-Week 12 | Measure of product characteristics |
| Perceived Health Risk Questionnaire | Baseline-Week 12 | Measure of perceived personal health risk |
| Penn State Smoking Dependence Questionnaire | Baseline-Week 12 | Dependence Measure (smoking and vaping) |
| Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM) | Baseline-Week 12 | Dependence Measure |
| Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions | Baseline-Week 12 | Dependence Measure (smoking and vaping) |
| Stages of Change | Baseline-Week 12 | Measure of intention to quit |
| Contemplation Ladder | Baseline-Week 12 | Measure of intention to quit |
| Quit Attempts | Baseline-Week 12 | Measure of intention to quit |
| Post-intervention Changes in Tobacco Use Behavior | 30 Day Follow up | Measure of 30-day tobacco use post-intervention of study products |
| Qualitative Interview | 30 Day Follow up | Themes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback |
| Urinary Anatabine Biomarker | Baseline -Week 12 | Measure of cigarette exposure and compliance |
| Number of Days Using Assigned Vaping Device | Baseline-Week 12 | collected through Interactive Voice Response (IVR) Review |
| Cigarette Evaluation Scale | Baseline-Week 12 | Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations. |
Countries
United States
Participant flow
Pre-assignment details
There were 106 screen failures.
Participants by arm
| Arm | Count |
|---|---|
| NNC Cigarette + Moderate Nicotine E-liquid + 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.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 6 |
| VLNC Cigarette + Moderate Nicotine E-liquid + Variety 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.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 7 |
| VLNC Cigarette + Low Nicotine E-liquid +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 Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 6 |
| VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor 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 Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 6 |
| NNC Cigarette + Low Nicotine E-liquid + Variety 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
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 5 |
| NNC Cigarette + Moderate Nicotine E-liquid + Variety 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 Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 5 |
| NNC Cigarette + Low Nicotine E-liquid + 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.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 10 |
| VLNC Cigarette + Low Nicotine E-liquid + Variety 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
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 5 |
| Total | 50 |
Baseline characteristics
| Characteristic | NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Total | VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 7.7 | 41.6 years STANDARD_DEVIATION 11.7 | 43.8 years STANDARD_DEVIATION 11.1 | 40.5 years STANDARD_DEVIATION 13.3 | 38 years STANDARD_DEVIATION 7 | 42.8 years STANDARD_DEVIATION 15.9 | 37.8 years STANDARD_DEVIATION 11.7 | 45.2 years STANDARD_DEVIATION 14.4 | 43.1 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 46 Participants | 5 Participants | 10 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 13 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized More than One Race | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown/Prefer Not to Answer | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 30 Participants | 1 Participants | 7 Participants | 2 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 50 participants | 5 participants | 10 participants | 5 participants | 5 participants | 6 participants | 6 participants | 7 participants |
| Sex/Gender, Customized Female | 3 Participants | 20 Participants | 2 Participants | 2 Participants | 0 Participants | 4 Participants | 4 Participants | 2 Participants | 3 Participants |
| Sex/Gender, Customized Male | 3 Participants | 29 Participants | 3 Participants | 7 Participants | 5 Participants | 1 Participants | 2 Participants | 4 Participants | 4 Participants |
| Sex/Gender, Customized Prefer not to answer | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 10 | 0 / 5 | 0 / 106 |
| other Total, other adverse events | 4 / 6 | 6 / 7 | 6 / 6 | 6 / 6 | 5 / 5 | 4 / 5 | 10 / 10 | 4 / 5 | 14 / 106 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 5 | 1 / 5 | 1 / 10 | 0 / 5 | 0 / 106 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Total Cigarettes Smoked Per Day | 21.6 number of cigarettes | Standard Deviation 3.7 |
| VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Total Cigarettes Smoked Per Day | 7.7 number of cigarettes | Standard Deviation 12.1 |
| VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Total Cigarettes Smoked Per Day | 18.4 number of cigarettes | Standard Deviation 8 |
| VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Total Cigarettes Smoked Per Day | 12.5 number of cigarettes | Standard Deviation 16.3 |
| NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Total Cigarettes Smoked Per Day | 34 number of cigarettes | Standard Deviation 14.8 |
| NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Total Cigarettes Smoked Per Day | 18.7 number of cigarettes | Standard Deviation 13.9 |
| NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Total Cigarettes Smoked Per Day | 17.7 number of cigarettes | Standard Deviation 8.5 |
| VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Total Cigarettes Smoked Per Day | 15.8 number of cigarettes | Standard Deviation 1.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 31 parts per million (ppm) | Standard Deviation 19.8 |
| VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 7.2 parts per million (ppm) | Standard Deviation 3.8 |
| VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 18 parts per million (ppm) | Standard Deviation 7.4 |
| VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 12 parts per million (ppm) | Standard Deviation 7 |
| NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 18.2 parts per million (ppm) | Standard Deviation 3.4 |
| NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 21 parts per million (ppm) | Standard Deviation 7.8 |
| NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 18.3 parts per million (ppm) | Standard Deviation 7.7 |
| VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | 32.5 parts per million (ppm) | Standard Deviation 21.9 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 1 participants |
| NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 1 participants |
| VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 1 participants |
| VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 3 participants |
| VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 3 participants |
| VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 1 participants |
| VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 3 participants |
| VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 2 participants |
| NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 4 participants |
| NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 0 participants |
| NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 3 participants |
| NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 1 participants |
| NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 1 participants |
| NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 6 participants |
| VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with 0% smoke free days | 0 participants |
| VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Number of Subjects With Smoke Free Days | Subjects with more than 0% smoke free days | 2 participants |
Other Pre-specified
Alcohol Use Questionnaire
Alcohol use
Time frame: Baseline-Week 12
Other Pre-specified
Breath Alcohol
Alcohol use
Time frame: Baseline - Week 12
Other Pre-specified
Center for Epidemiologic Studies Depression Scale
Measure of discomfort and dysfunction
Time frame: Baseline, Weeks 04, 08, 12
Other Pre-specified
Cigarette and Product Evaluation Scale
Measure of product characteristics
Time frame: Baseline-Week 12
Other Pre-specified
Cigarette Evaluation Scale
Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations.
Time frame: Baseline-Week 12
Other Pre-specified
Contemplation Ladder
Measure of intention to quit
Time frame: Baseline-Week 12
Other Pre-specified
Context of Product Use Questionnaire
Measure of smoking and vaping context
Time frame: Baseline-Week 12
Other Pre-specified
Drop-out Rate
Drop-out rate
Time frame: Baseline-Week 12
Other Pre-specified
Drug Use Questionnaire
Drug use
Time frame: Baseline-Week 12
Other Pre-specified
Environmental and Social Influences on Tobacco Use Questionnaire
Measure of smoking and vaping context
Time frame: Baseline-Week 12
Other Pre-specified
Fagerstrom Nicotine Dependence Scale
Dependence Measure
Time frame: Baseline-Week 12
Other Pre-specified
IVR Review and Timeline Followback
Measure of compliance
Time frame: Baseline-Week 12
Other Pre-specified
IVR Review and Timeline Followback and E-liquid Accountability
Measure of vaping device use
Time frame: Baseline-Week 12
Other Pre-specified
Mercapturic Acids
Measure of toxicant exposure
Time frame: Baseline-Week 12
Other Pre-specified
Minnesota Nicotine Withdrawal Scale
Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms.
Time frame: Baseline-Week 12
Other Pre-specified
Number of Choices to Smoke in Preference Assessment Task
Measure of relative reinforcement
Time frame: Week 00
Other Pre-specified
Number of Days Using Assigned Vaping Device
collected through Interactive Voice Response (IVR) Review
Time frame: Baseline-Week 12
Other Pre-specified
Penn State Smoking Dependence Questionnaire
Dependence Measure (smoking and vaping)
Time frame: Baseline-Week 12
Other Pre-specified
Perceived Health Risk Questionnaire
Measure of perceived personal health risk
Time frame: Baseline-Week 12
Other Pre-specified
Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions
Dependence Measure (smoking and vaping)
Time frame: Baseline-Week 12
Other Pre-specified
Post-intervention Changes in Tobacco Use Behavior
Measure of 30-day tobacco use post-intervention of study products
Time frame: 30 Day Follow up
Other Pre-specified
Predicted Behavior Questionnaire
Measure of hypothetical cigarette and vaping device use
Time frame: Week 12
Other Pre-specified
Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM)
Dependence Measure
Time frame: Baseline-Week 12
Other Pre-specified
Puff Topography
Measure of smoking and vaping topography
Time frame: Weeks 01 and 10
Other Pre-specified
Purchase Task
Measure of relative reinforcement and substitution
Time frame: Baseline, Week 12
Other Pre-specified
Qualitative Interview
Themes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback
Time frame: 30 Day Follow up
Other Pre-specified
Quit Attempts
Measure of intention to quit
Time frame: Baseline-Week 12
Other Pre-specified
Smoking and Vaping Expectancy Questionnaires
Measure of product expectancy
Time frame: Baseline-Week 12
Other Pre-specified
Stages of Change
Measure of intention to quit
Time frame: Baseline-Week 12
Other Pre-specified
Study Cigarettes Smoked Per Day
Study cigarettes smoked per day
Time frame: Baseline-Week 12
Other Pre-specified
Total Nicotine Equivalents
Measure of nicotine exposure
Time frame: Baseline - Week 12
Other Pre-specified
Urge to Use Questionnaire
Measure of discomfort and dysfunction
Time frame: Baseline-Week 12
Other Pre-specified
Urinary Anatabine Biomarker
Measure of cigarette exposure and compliance
Time frame: Baseline -Week 12
Other Pre-specified
Urine Drug Screen
Drug use
Time frame: Baseline, Week 12
Other Pre-specified
Vaping Utility Questionnaire
Measure of product expectancy
Time frame: Baseline, Week 12
Other Pre-specified
Weight
Weight
Time frame: Baseline-Week 12