E-cigarette Use
Conditions
Brief summary
This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) vaping, while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults (youth). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.
Detailed description
We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.
Interventions
OTHERECIG lab session 1
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 2
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 3
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 4
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 5
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 6
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 7
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
OTHERECIG lab session 8
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* A current exclusive e-cigarette user (\>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine) * 21-25 years old * Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions * Willing to complete five, 6 hour lab visits * Able to read and speak English * Willing to provide informed consent
Exclusion criteria
* Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease * Unstable or significant psychiatric conditions (past and stable conditions will be allowed) * History of cardiac event or distress within the past 3 months * Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding * Use of other tobacco products \> 5 days in the past month * Current marijuana use \> 5 times per month * Currently engaging in a vaping cessation attempt * Ohio State University (OSU) verifies study project 2 current membership/past participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Nicotine Concentration | 0, 5, 10, 35 min. | Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min. |
| Puff Count | 30 minutes | E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session. |
| Average Puff Duration | 30 minutes | E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds. |
| Average Puff Volume | 30 minutes | E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml. |
| Lung Function Assessment | Baseline and 35 minutes | Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC) |
| Airway Inflammation (NIOX VERO) | 35 minutes | Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory E-Cigarette Expectancies Scale (SEES) | Baseline | Background measures. Comprised of 9 items each of which range 0-4 from never to almost always. The 3 subscales (enjoyment of taste and smell, pleasurable physical sensations, enjoyment of vapor cloud production) are the average of 3 items each; scores range from 0 to 4 with higher scores indicating greater enjoyment. |
| Vascular Reactivity | Pre-Vaping Session at Visit 1 | Endothelial function will be collected through EndoPAT device. Specifically, the natural log of RHI, the reactive hyperemia index, will be recorded. The RHI (Reactive Hyperemia Index) or LnRHI (natural log of RHI) is the post-to-pre occlusion PAT™ signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone. Values less than 1.67 or higher than 0.51 are considered to be abnormal. |
| Modified Cigarette Dependence Scale | Baseline | Assess e-cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence. |
| Drug Effects/Liking Questionnaire | 35 minutes | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. |
| Modified Cigarette Evaluation Questionnaire (mCEQ) | 35 minutes | The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to e-cigarettes (e.g., reward, satisfaction). The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction. |
| E-cigarette Purchase Task - Breakpoint | 35 minutes | Behavioral economic demand Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their study product. Specifically they will be asked, Thinking about the study product, how many puffs of e-cigarette would you smoke if they were each at the following prices?. Breakpoint is the first price of zero consumption. |
| Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | 0, 5, 10, 35 min. | E-cig craving/suppression of craving and withdraw will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges (QSU): Brief Form with a modified version (replacing the word cigarette with e-cigarette). This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Population Full population of participants evaluated at baseline | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Withdrawal by Study Team | 1 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Overall Population |
|---|---|
| Age, Continuous | 22.36 years STANDARD_DEVIATION 1.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 36 Participants |
| Years of regular e-cigarette use | 3.29 years STANDARD_DEVIATION 2.13 |
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 / 65 | 0 / 64 | 0 / 61 | 0 / 64 | 0 / 64 | 0 / 63 | 0 / 60 | 0 / 65 | 0 / 87 |
| other Total, other adverse events | 0 / 65 | 0 / 64 | 0 / 61 | 0 / 64 | 0 / 64 | 0 / 63 | 0 / 60 | 0 / 65 | 0 / 87 |
| serious Total, serious adverse events | 0 / 65 | 0 / 64 | 0 / 61 | 0 / 64 | 0 / 64 | 0 / 63 | 0 / 60 | 0 / 65 | 0 / 87 |
Outcome results
Primary
Airway Inflammation (NIOX VERO)
Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.
Time frame: 35 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Airway Inflammation (NIOX VERO) | 18.94 ppb | Standard Deviation 11.52 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Airway Inflammation (NIOX VERO) | 19.27 ppb | Standard Deviation 13.38 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Airway Inflammation (NIOX VERO) | 18.95 ppb | Standard Deviation 12.14 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Airway Inflammation (NIOX VERO) | 19.69 ppb | Standard Deviation 11.86 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Airway Inflammation (NIOX VERO) | 18.52 ppb | Standard Deviation 12.76 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Airway Inflammation (NIOX VERO) | 21.94 ppb | Standard Deviation 19.51 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Airway Inflammation (NIOX VERO) | 19.20 ppb | Standard Deviation 11.43 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Airway Inflammation (NIOX VERO) | 20.02 ppb | Standard Deviation 12.55 |
| Usual Brand | Airway Inflammation (NIOX VERO) | 18.77 ppb | Standard Deviation 12.7 |
Primary
Average Puff Duration
E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.
Time frame: 30 minutes
Population: Participants who attended the study visit and whose puff duration was able to be recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Average Puff Duration | 3.20 seconds | Standard Deviation 1.04 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Average Puff Duration | 3.04 seconds | Standard Deviation 1.08 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Average Puff Duration | 3.16 seconds | Standard Deviation 1.07 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Average Puff Duration | 3.15 seconds | Standard Deviation 1.1 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Average Puff Duration | 2.65 seconds | Standard Deviation 0.92 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Average Puff Duration | 2.57 seconds | Standard Deviation 0.97 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Average Puff Duration | 2.77 seconds | Standard Deviation 1.03 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Average Puff Duration | 2.75 seconds | Standard Deviation 1.08 |
| Usual Brand | Average Puff Duration | 2.70 seconds | Standard Deviation 1.15 |
Primary
Average Puff Volume
E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.
Time frame: 30 minutes
Population: Participants who attended the study visit and whose puff volume was able to be recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Average Puff Volume | 48.68 ml | Standard Deviation 17.28 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Average Puff Volume | 46.31 ml | Standard Deviation 18.44 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Average Puff Volume | 50.64 ml | Standard Deviation 22.05 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Average Puff Volume | 51.92 ml | Standard Deviation 30.01 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Average Puff Volume | 36.82 ml | Standard Deviation 12.13 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Average Puff Volume | 35.12 ml | Standard Deviation 13.16 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Average Puff Volume | 41.76 ml | Standard Deviation 15.35 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Average Puff Volume | 40.86 ml | Standard Deviation 17.26 |
| Usual Brand | Average Puff Volume | 69.29 ml | Standard Deviation 40.42 |
Primary
Lung Function Assessment
Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)
Time frame: Baseline and 35 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Lung Function Assessment | FVC | -0.02 Liters | Standard Deviation 0.29 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Lung Function Assessment | FEV | -0.03 Liters | Standard Deviation 0.21 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Lung Function Assessment | FVC | -0.01 Liters | Standard Deviation 0.25 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Lung Function Assessment | FEV | -0.05 Liters | Standard Deviation 0.21 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Lung Function Assessment | FVC | -0.0006 Liters | Standard Deviation 0.24 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Lung Function Assessment | FEV | -0.01 Liters | Standard Deviation 0.19 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Lung Function Assessment | FEV | 0.003 Liters | Standard Deviation 0.24 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Lung Function Assessment | FVC | 0.30 Liters | Standard Deviation 2.36 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Lung Function Assessment | FEV | -0.08 Liters | Standard Deviation 0.4 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Lung Function Assessment | FVC | -0.12 Liters | Standard Deviation 0.53 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Lung Function Assessment | FEV | -0.02 Liters | Standard Deviation 0.38 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Lung Function Assessment | FVC | -0.02 Liters | Standard Deviation 0.53 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Lung Function Assessment | FEV | -0.05 Liters | Standard Deviation 0.24 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Lung Function Assessment | FVC | -0.01 Liters | Standard Deviation 0.37 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Lung Function Assessment | FEV | -0.04 Liters | Standard Deviation 0.24 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Lung Function Assessment | FVC | -0.23 Liters | Standard Deviation 1.68 |
| Usual Brand | Lung Function Assessment | FVC | 0.13 Liters | Standard Deviation 0.42 |
| Usual Brand | Lung Function Assessment | FEV | 0.09 Liters | Standard Deviation 0.39 |
Primary
Plasma Nicotine Concentration
Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.
Time frame: 0, 5, 10, 35 min.
Population: Number analyzed is slightly different at each of the time points due to missing blood draws
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Plasma Nicotine Concentration | 10 Minutes | 3.12 ng/ml |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Plasma Nicotine Concentration | Baseline | 0.78 ng/ml |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Plasma Nicotine Concentration | 5 Minutes | 3.04 ng/ml |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Plasma Nicotine Concentration | 35 Minutes | 4.46 ng/ml |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Plasma Nicotine Concentration | 5 Minutes | 2.63 ng/ml |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Plasma Nicotine Concentration | 10 Minutes | 3.18 ng/ml |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Plasma Nicotine Concentration | 35 Minutes | 3.51 ng/ml |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Plasma Nicotine Concentration | Baseline | 1.08 ng/ml |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Plasma Nicotine Concentration | 5 Minutes | 4.47 ng/ml |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Plasma Nicotine Concentration | 10 Minutes | 4.92 ng/ml |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Plasma Nicotine Concentration | Baseline | 0.89 ng/ml |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Plasma Nicotine Concentration | 35 Minutes | 5.97 ng/ml |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Plasma Nicotine Concentration | 10 Minutes | 4.66 ng/ml |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Plasma Nicotine Concentration | 5 Minutes | 4.66 ng/ml |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Plasma Nicotine Concentration | 35 Minutes | 5.28 ng/ml |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Plasma Nicotine Concentration | Baseline | 1.16 ng/ml |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Plasma Nicotine Concentration | 35 Minutes | 6.39 ng/ml |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Plasma Nicotine Concentration | Baseline | 0.80 ng/ml |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Plasma Nicotine Concentration | 5 Minutes | 3.63 ng/ml |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Plasma Nicotine Concentration | 10 Minutes | 4.45 ng/ml |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Plasma Nicotine Concentration | 35 Minutes | 4.23 ng/ml |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Plasma Nicotine Concentration | Baseline | 0.88 ng/ml |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Plasma Nicotine Concentration | 5 Minutes | 3.29 ng/ml |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Plasma Nicotine Concentration | 10 Minutes | 4.14 ng/ml |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Plasma Nicotine Concentration | 10 Minutes | 8.10 ng/ml |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Plasma Nicotine Concentration | 5 Minutes | 7.83 ng/ml |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Plasma Nicotine Concentration | Baseline | 1.03 ng/ml |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Plasma Nicotine Concentration | 35 Minutes | 12.90 ng/ml |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Plasma Nicotine Concentration | Baseline | 1.01 ng/ml |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Plasma Nicotine Concentration | 10 Minutes | 7.02 ng/ml |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Plasma Nicotine Concentration | 5 Minutes | 8.76 ng/ml |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Plasma Nicotine Concentration | 35 Minutes | 10.60 ng/ml |
| Usual Brand | Plasma Nicotine Concentration | 35 Minutes | 20.40 ng/ml |
| Usual Brand | Plasma Nicotine Concentration | Baseline | 0.43 ng/ml |
| Usual Brand | Plasma Nicotine Concentration | 5 Minutes | 12.50 ng/ml |
| Usual Brand | Plasma Nicotine Concentration | 10 Minutes | 14.10 ng/ml |
Primary
Puff Count
E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Puff Count | 16.17 Number of Puffs | Standard Deviation 12.04 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Puff Count | 16.67 Number of Puffs | Standard Deviation 13.84 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Puff Count | 17.67 Number of Puffs | Standard Deviation 13.54 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Puff Count | 17.88 Number of Puffs | Standard Deviation 13.9 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Puff Count | 12.52 Number of Puffs | Standard Deviation 12.13 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Puff Count | 11.29 Number of Puffs | Standard Deviation 12.64 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Puff Count | 14.50 Number of Puffs | Standard Deviation 11.8 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Puff Count | 13.97 Number of Puffs | Standard Deviation 12.07 |
| Usual Brand | Puff Count | 12.40 Number of Puffs | Standard Deviation 10.69 |
Secondary
Drug Effects/Liking Questionnaire
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.
Time frame: 35 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Want | 40.40 score on a scale | Standard Deviation 23.83 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Enjoy | 46.51 score on a scale | Standard Deviation 25.12 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Like | 47.54 score on a scale | Standard Deviation 25.32 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Satisfying | 44.89 score on a scale | Standard Deviation 24.35 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 46.28 score on a scale | Standard Deviation 24.26 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Satisfying | 37.45 score on a scale | Standard Deviation 23.26 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Want | 32.59 score on a scale | Standard Deviation 23.08 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Like | 35.36 score on a scale | Standard Deviation 25.34 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Enjoy | 36.70 score on a scale | Standard Deviation 26.42 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 36.42 score on a scale | Standard Deviation 24.96 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 50.23 score on a scale | Standard Deviation 26.53 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Want | 44.69 score on a scale | Standard Deviation 26.44 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Like | 48.82 score on a scale | Standard Deviation 27.28 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Satisfying | 48.84 score on a scale | Standard Deviation 26.06 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Drug Effects/Liking Questionnaire | Enjoy | 49.66 score on a scale | Standard Deviation 27.01 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Like | 41.94 score on a scale | Standard Deviation 24.3 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Enjoy | 43.02 score on a scale | Standard Deviation 25.03 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Want | 37.78 score on a scale | Standard Deviation 22.14 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 44.66 score on a scale | Standard Deviation 23.63 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Satisfying | 41.98 score on a scale | Standard Deviation 25.56 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Like | 27.44 score on a scale | Standard Deviation 27.4 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 29.33 score on a scale | Standard Deviation 27.92 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Enjoy | 27.39 score on a scale | Standard Deviation 26.77 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Want | 27.48 score on a scale | Standard Deviation 25.41 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Satisfying | 33.95 score on a scale | Standard Deviation 26.97 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 18.60 score on a scale | Standard Deviation 20.17 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Satisfying | 25.05 score on a scale | Standard Deviation 23.64 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Want | 17.16 score on a scale | Standard Deviation 21.13 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Enjoy | 18.27 score on a scale | Standard Deviation 21.24 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Like | 17.08 score on a scale | Standard Deviation 21.59 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Enjoy | 50.02 score on a scale | Standard Deviation 25.74 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Like | 49.67 score on a scale | Standard Deviation 27.13 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 52.13 score on a scale | Standard Deviation 25 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Satisfying | 52.48 score on a scale | Standard Deviation 23.69 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Drug Effects/Liking Questionnaire | Want | 43.58 score on a scale | Standard Deviation 24.87 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Pleasurable | 34.48 score on a scale | Standard Deviation 24.97 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Like | 31.51 score on a scale | Standard Deviation 25.04 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Want | 29.75 score on a scale | Standard Deviation 24.76 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Enjoy | 31.42 score on a scale | Standard Deviation 25.05 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Drug Effects/Liking Questionnaire | Satisfying | 39.69 score on a scale | Standard Deviation 26.24 |
| Usual Brand | Drug Effects/Liking Questionnaire | Want | 45.40 score on a scale | Standard Deviation 20.93 |
| Usual Brand | Drug Effects/Liking Questionnaire | Satisfying | 74.33 score on a scale | Standard Deviation 15.34 |
| Usual Brand | Drug Effects/Liking Questionnaire | Enjoy | 72.57 score on a scale | Standard Deviation 17.73 |
| Usual Brand | Drug Effects/Liking Questionnaire | Like | 69.05 score on a scale | Standard Deviation 21.81 |
| Usual Brand | Drug Effects/Liking Questionnaire | Pleasurable | 72.57 score on a scale | Standard Deviation 15.94 |
Secondary
E-cigarette Purchase Task - Breakpoint
Behavioral economic demand Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their study product. Specifically they will be asked, Thinking about the study product, how many puffs of e-cigarette would you smoke if they were each at the following prices?. Breakpoint is the first price of zero consumption.
Time frame: 35 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | E-cigarette Purchase Task - Breakpoint | 0.5 Dollars |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | E-cigarette Purchase Task - Breakpoint | 0.38 Dollars |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | E-cigarette Purchase Task - Breakpoint | 1 Dollars |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | E-cigarette Purchase Task - Breakpoint | 0.5 Dollars |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | E-cigarette Purchase Task - Breakpoint | 0.5 Dollars |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | E-cigarette Purchase Task - Breakpoint | 0.25 Dollars |
| High Concentration Nicotine Salt (5%), Menthol Flavor | E-cigarette Purchase Task - Breakpoint | 1 Dollars |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | E-cigarette Purchase Task - Breakpoint | 0.5 Dollars |
| Usual Brand | E-cigarette Purchase Task - Breakpoint | 2.0 Dollars |
Secondary
Modified Cigarette Dependence Scale
Assess e-cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Time frame: Baseline
Population: Participants who responded to all items on the modified cigarette dependence scale at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Modified Cigarette Dependence Scale | 17.37 score on a scale | Standard Deviation 4.18 |
Secondary
Modified Cigarette Evaluation Questionnaire (mCEQ)
The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to e-cigarettes (e.g., reward, satisfaction). The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.
Time frame: 35 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.18 score on a scale | Standard Deviation 0.43 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.19 score on a scale | Standard Deviation 0.99 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 3.25 score on a scale | Standard Deviation 1.58 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 3.20 score on a scale | Standard Deviation 1.55 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 3.35 score on a scale | Standard Deviation 1.32 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.31 score on a scale | Standard Deviation 0.57 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 2.78 score on a scale | Standard Deviation 1.04 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 3.17 score on a scale | Standard Deviation 1.44 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.17 score on a scale | Standard Deviation 0.81 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 2.55 score on a scale | Standard Deviation 1.3 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.29 score on a scale | Standard Deviation 0.5 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 3.58 score on a scale | Standard Deviation 1.31 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.35 score on a scale | Standard Deviation 1.1 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 3.62 score on a scale | Standard Deviation 1.66 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 3.39 score on a scale | Standard Deviation 1.38 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 2.83 score on a scale | Standard Deviation 1.34 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.35 score on a scale | Standard Deviation 0.95 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 3.23 score on a scale | Standard Deviation 1.44 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.23 score on a scale | Standard Deviation 0.98 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 2.97 score on a scale | Standard Deviation 1.07 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 3.45 score on a scale | Standard Deviation 1.58 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.24 score on a scale | Standard Deviation 1.13 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 2.93 score on a scale | Standard Deviation 1.33 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.63 score on a scale | Standard Deviation 0.86 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 2.22 score on a scale | Standard Deviation 1.5 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.01 score on a scale | Standard Deviation 0.94 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 2.26 score on a scale | Standard Deviation 0.97 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.63 score on a scale | Standard Deviation 0.74 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 1.73 score on a scale | Standard Deviation 1.19 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 2.97 score on a scale | Standard Deviation 1.54 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.73 score on a scale | Standard Deviation 1.1 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 3.80 score on a scale | Standard Deviation 1.39 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.50 score on a scale | Standard Deviation 1.18 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 4.05 score on a scale | Standard Deviation 1.68 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 3.32 score on a scale | Standard Deviation 1.57 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Aversion | 1.78 score on a scale | Standard Deviation 1.25 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Sensation | 2.77 score on a scale | Standard Deviation 1.48 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Satisfaction | 2.93 score on a scale | Standard Deviation 1.22 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Craving | 3.40 score on a scale | Standard Deviation 1.53 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Modified Cigarette Evaluation Questionnaire (mCEQ) | Reward | 2.32 score on a scale | Standard Deviation 1.16 |
Secondary
Sensory E-Cigarette Expectancies Scale (SEES)
Background measures. Comprised of 9 items each of which range 0-4 from never to almost always. The 3 subscales (enjoyment of taste and smell, pleasurable physical sensations, enjoyment of vapor cloud production) are the average of 3 items each; scores range from 0 to 4 with higher scores indicating greater enjoyment.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Sensory E-Cigarette Expectancies Scale (SEES) | Enjoyment of Taste and Smell | 2.69 score on a scale | Standard Deviation 0.77 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Sensory E-Cigarette Expectancies Scale (SEES) | Pleasurable Physical Sensations | 2.76 score on a scale | Standard Deviation 0.87 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Sensory E-Cigarette Expectancies Scale (SEES) | Enjoyment of Vapor Cloud Production | 1.66 score on a scale | Standard Deviation 1.06 |
Secondary
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form
E-cig craving/suppression of craving and withdraw will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges (QSU): Brief Form with a modified version (replacing the word cigarette with e-cigarette). This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Time frame: 0, 5, 10, 35 min.
Population: Participants who attended the study product visit and fully completed the QSU items
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 9.57 units on a scale | Standard Deviation 5.51 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.92 units on a scale | Standard Deviation 5.82 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 24.85 units on a scale | Standard Deviation 8.27 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 18.92 units on a scale | Standard Deviation 7.63 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.77 units on a scale | Standard Deviation 6.14 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 13.78 units on a scale | Standard Deviation 7.18 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 17.49 units on a scale | Standard Deviation 8.04 |
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 16.17 units on a scale | Standard Deviation 7.94 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 18.38 units on a scale | Standard Deviation 6.78 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 9.58 units on a scale | Standard Deviation 4.63 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 13.88 units on a scale | Standard Deviation 7.02 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 16.72 units on a scale | Standard Deviation 7.68 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 17.22 units on a scale | Standard Deviation 6.96 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 25.44 units on a scale | Standard Deviation 7.02 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 10.03 units on a scale | Standard Deviation 4.97 |
| Low Concentration Free-base Nicotine (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.56 units on a scale | Standard Deviation 5.4 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 9.41 units on a scale | Standard Deviation 4.68 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.93 units on a scale | Standard Deviation 5.44 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 17.64 units on a scale | Standard Deviation 7.54 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 25.51 units on a scale | Standard Deviation 7.43 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 14.28 units on a scale | Standard Deviation 7.18 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 19.54 units on a scale | Standard Deviation 7.43 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.98 units on a scale | Standard Deviation 5.82 |
| Low Concentration Nicotine Salt (1%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 16.87 units on a scale | Standard Deviation 7.02 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 9.28 units on a scale | Standard Deviation 4.53 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 19.00 units on a scale | Standard Deviation 7.5 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.77 units on a scale | Standard Deviation 5.39 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.92 units on a scale | Standard Deviation 5.13 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 14.08 units on a scale | Standard Deviation 7.22 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 17.73 units on a scale | Standard Deviation 7.46 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 25.56 units on a scale | Standard Deviation 7.15 |
| Low Concentration Nicotine Salt (1%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 16.88 units on a scale | Standard Deviation 7.79 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 15.29 units on a scale | Standard Deviation 7.11 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 13.69 units on a scale | Standard Deviation 7.14 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 8.94 units on a scale | Standard Deviation 4.56 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 15.41 units on a scale | Standard Deviation 7.15 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.23 units on a scale | Standard Deviation 4.71 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 16.34 units on a scale | Standard Deviation 7.47 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.08 units on a scale | Standard Deviation 5.58 |
| High Concentration Free-base Nicotine (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 24.52 units on a scale | Standard Deviation 7.26 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 16.56 units on a scale | Standard Deviation 7.56 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 17.44 units on a scale | Standard Deviation 7.74 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 25.25 units on a scale | Standard Deviation 7.55 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.35 units on a scale | Standard Deviation 5.91 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 13.68 units on a scale | Standard Deviation 6.83 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 9.38 units on a scale | Standard Deviation 4.45 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.71 units on a scale | Standard Deviation 5.3 |
| High Concentration Free-base Nicotine (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 16.54 units on a scale | Standard Deviation 7.65 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 9.95 units on a scale | Standard Deviation 5.4 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 13.25 units on a scale | Standard Deviation 7.35 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 24.03 units on a scale | Standard Deviation 7.85 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 16.78 units on a scale | Standard Deviation 7.02 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 15.15 units on a scale | Standard Deviation 6.88 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 14.55 units on a scale | Standard Deviation 6.45 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.37 units on a scale | Standard Deviation 4.96 |
| High Concentration Nicotine Salt (5%), Menthol Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 8.40 units on a scale | Standard Deviation 3.82 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.66 units on a scale | Standard Deviation 4.84 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 16.98 units on a scale | Standard Deviation 7.13 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 24.09 units on a scale | Standard Deviation 7.97 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 14.92 units on a scale | Standard Deviation 7.48 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 10.02 units on a scale | Standard Deviation 4.97 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 15.74 units on a scale | Standard Deviation 6.83 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 13.80 units on a scale | Standard Deviation 7.74 |
| High Concentration Nicotine Salt (5%), Tobacco Flavor | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 8.95 units on a scale | Standard Deviation 4.55 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 5 min | 14.45 units on a scale | Standard Deviation 6.85 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 35 min | 8.09 units on a scale | Standard Deviation 4.29 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 0min | 26.18 units on a scale | Standard Deviation 7.44 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 10 min | 9.40 units on a scale | Standard Deviation 5.05 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 35 min | 12.49 units on a scale | Standard Deviation 5.83 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 0min | 15.64 units on a scale | Standard Deviation 6.92 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Desire: 10 min | 13.76 units on a scale | Standard Deviation 6.75 |
| Usual Brand | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | QSU Relief: 5min | 9.95 units on a scale | Standard Deviation 4.84 |
Secondary
Vascular Reactivity
Endothelial function will be collected through EndoPAT device. Specifically, the natural log of RHI, the reactive hyperemia index, will be recorded. The RHI (Reactive Hyperemia Index) or LnRHI (natural log of RHI) is the post-to-pre occlusion PAT™ signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone. Values less than 1.67 or higher than 0.51 are considered to be abnormal.
Time frame: Pre-Vaping Session at Visit 1
Population: Participants who attended the baseline study visit and whose endothelial function was able to be recorded with the EndoPAT device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration Free-base Nicotine (1%), Menthol Flavor | Vascular Reactivity | 0.47 ratio | Standard Deviation 0.26 |