Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.
Detailed description
PRIMARY OBJECTIVES: I. To characterize the effects of switching to nicotine versus (vs.) placebo standard research E-cigarettes (SRECs) from combustible cigarettes (CCs) on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers. II. To characterize the differences between male and female CC smokers when switching to nicotine versus (vs.) placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms. EXPLORATORY OBJECTIVE: I. To characterize which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers. OUTLINE: Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
Interventions
Received NRT (Electronic Cigarette - With Nicotine)
OTHERQuestionnaire Administration
Ancillary studies
DEVICEElectronic Cigarette
Electronic Cigarette - with Nicotine
Sponsors
M.D. Anderson Cancer Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 21 years or older * Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days) * Have an address where he/she can receive mail * Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI * Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site. * Willing to use tobacco-flavored study electronic cigarettes * Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit. * The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.
Exclusion criteria
* Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9 * Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes). * Evidence of cognitive deficits or instability that would preclude reliable study participation. * Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use. * Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures) * Individuals who reside in an area that is outside of our shipping company's area of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline or are unable to come in to clinic to provide necessary samples and/or collect study products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes Per Day | 2 weeks | Mean cigarettes per day (CPD) smoked during the phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electronic Cigarette Sessions Per Day | 2 weeks | Study electronic cigarette use measured by the mean number of sessions per day during each phase for male and female participants. |
| Total Nicotine Equivalents (TNE) | 2 weeks | A measure of nicotine exposure, calculated as the sum of total nicotine, cotinine, 3'-hydroxycotinine, and nicotine N-oxide excreted in urine, collected at the end of each phase for male and female participants. |
| Anabasine | 2 weeks | A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure. |
| Nicotelline | 2 weeks | A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure. |
| Perceived Health Risk Questionnaire (PHRQ) | 2 weeks | Evaluation of participants' beliefs about their risks of developing health conditions from cigarettes or electronic cigarette collected at the end of each phase for male and female participants. Range 1-10, with higher values indicating greater perceived risk of negative health outcomes. |
| Product Evaluation Scales (PES) | 2 weeks | Evaluation of explicit cigarette or electronic cigarette product liking collected at the end of each phase for male and female participants. Range 1-7, with higher values indicating more unpleasant ratings. |
| Implicit Association Test (IAT) | 2 weeks | Evaluation of implicit cigarette or electronic cigarette liking collected at the end of each phase for male and female participants. Range: -1 to 1, with more negative values indicating a more negative attitude toward the cigarette product |
| Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 2 weeks | Evaluation of the perceived outcomes of cigarette or electronic cigarette use collected at the end of each phase for male and female participants. Range 0 to 9, with larger values indicating greater perceived negative consequences of cigarette use |
| Purchase Task Breakpoint Measure | 2 weeks | Evaluation of the Purchase Task Breakpoint measure (first price at which consumption goes to zero, i.e., unwilling to pay) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.05 - 251, dollars per cigarette or per electronic cigarette puff with higher values indicating the willingness to smoke/vape at a higher price. |
| Purchase Task Omax Measure | 2 weeks | Evaluation of the Purchase Task Omax measure (maximum financial expenditure on the product) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.03 - 1001, the maximum expenditure in dollars on cigarettes or electronic cigarette puffs with higher values indicating greater expenditure |
| Purchase Task Pmax Measure | 2 weeks | Evaluation of the Purchase Task Pmax measure (price at which expenditure is maximized) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.01 - 1001, the price of the cigarette or electronic cigarette puffs when the Omax is reached |
| Purchase Task Elasticity of Demand Measure | 2 weeks | Evaluation of the Purchase Task Elasticity of Demand measure (sensitivity of product consumption to increases in cost) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.0001 - 2.69, the elasticity of the demand for cigarettes or electronic cigarette puffs, with higher values indicating a greater sensitivity in reducing the consumption in response to the price increases |
| Fagerström Test for Cigarette Dependence (FTCD) | 2 weeks | Evaluation of cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 10, with higher values indicating greater cigarette dependence |
| Penn State Electronic Cigarette Dependence Index (PSECDI) | 2 weeks | Evaluation of electronic cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 20, with higher scores indicating greater electronic cigarette dependence |
| Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 2 weeks | Evaluation of nicotine withdrawal symptoms collected at the end of each phase for male and female participants. Range 0 to 60, with higher scores indicating greater nicotine withdrawal |
| Questionnaire of Smoking Urges-Brief (QSU-Brief) | 2 weeks | Evaluation of the craving to smoke cigarettes collected at the end of each phase for male and female participants. Range 1 to 10, with higher values indicating greater urge to smoke |
| Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 2 weeks | Evaluation of positive affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater positive affect |
| Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 2 weeks | Evaluation of negative affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater negative affect |
| Smartphone Daily Measures of Nicotine Dependence Symptoms | 2 weeks | Evaluation of mean nicotine dependence symptoms collected daily during each phase. Range 1 to 5, with higher values indicating greater nicotine dependence symptoms |
| Purchase Task Demand Intensity Measure | 2 weeks | Evaluation of the Purchase Task Demand Intensity measure (consumption at the lowest price) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 1 - 351, the number of cigarettes or electronic cigarette puffs with higher values indicating an intension to smoke/vape more when the price is set as 0 |
| American Thoracic Society Questionnaire (ATSQ) | 2 weeks | Evaluation of respiratory symptoms collected at the end of each phase for male and female participants. Range 8 to 40, with higher numbers indicating more respiratory symptoms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Robinson
M.D. Anderson Cancer Center
Participant flow
Recruitment details
Participants were adult individuals residing in the state of Texas who completed the study remotely.
Pre-assignment details
Of the 1363 potential participants who responded to study advertising, 702 were screened for interest and eligibility. Of those screened, 130 were ineligible and 402 declined to participate. A total of 169 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: Usual Brand Cigarette Phase (Men) Two weeks of smoking usual brand cigarettes followed by two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (SREC) and the two weeks of using the Nicotine (5% nicotine content) SREC, with SREC order counterbalanced. | 87 |
| Phase 1: Usual Brand Cigarette Phase (Women) Two weeks of smoking usual brand cigarettes followed by two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (SREC) and the two weeks of using the Nicotine (5% nicotine content) SREC, with SREC order counterbalanced. | 82 |
| Total | 169 |
Baseline characteristics
| Characteristic | Phase 1: Usual Brand Cigarette Phase (Men) | Total | Phase 1: Usual Brand Cigarette Phase (Women) |
|---|---|---|---|
| Age, Continuous | 44.51 years STANDARD_DEVIATION 11.26 | 44.54 years STANDARD_DEVIATION 10.72 | 44.57 years STANDARD_DEVIATION 10.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 22 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 147 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 44 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 102 Participants | 55 Participants |
| Region of Enrollment United States | 87 participants | 169 participants | 82 participants |
| Sex: Female, Male Female | 0 Participants | 82 Participants | 82 Participants |
| Sex: Female, Male Male | 87 Participants | 87 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 87 | 0 / 87 | 0 / 82 | 0 / 82 | 0 / 82 |
| other Total, other adverse events | 0 / 87 | 0 / 87 | 0 / 87 | 0 / 82 | 0 / 82 | 0 / 82 |
| serious Total, serious adverse events | 0 / 87 | 1 / 87 | 3 / 87 | 1 / 82 | 1 / 82 | 2 / 82 |
Outcome results
Primary
Cigarettes Per Day
Mean cigarettes per day (CPD) smoked during the phase
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Cigarettes Per Day | 14.20 Cigarettes per Day | Standard Deviation 9.01 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Cigarettes Per Day | 4.08 Cigarettes per Day | Standard Deviation 6.31 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Cigarettes Per Day | 4.55 Cigarettes per Day | Standard Deviation 7.25 |
| Usual Brand Cigarette Phase (Women) | Cigarettes Per Day | 14.09 Cigarettes per Day | Standard Deviation 7.66 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Cigarettes Per Day | 3.85 Cigarettes per Day | Standard Deviation 5.3 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Cigarettes Per Day | 3.63 Cigarettes per Day | Standard Deviation 4.72 |
Secondary
American Thoracic Society Questionnaire (ATSQ)
Evaluation of respiratory symptoms collected at the end of each phase for male and female participants. Range 8 to 40, with higher numbers indicating more respiratory symptoms
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | American Thoracic Society Questionnaire (ATSQ) | 18.30 Units on a scale | Standard Deviation 8.98 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | American Thoracic Society Questionnaire (ATSQ) | 16.85 Units on a scale | Standard Deviation 8.86 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | American Thoracic Society Questionnaire (ATSQ) | 16.93 Units on a scale | Standard Deviation 8.59 |
| Usual Brand Cigarette Phase (Women) | American Thoracic Society Questionnaire (ATSQ) | 18.17 Units on a scale | Standard Deviation 8.59 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | American Thoracic Society Questionnaire (ATSQ) | 16.13 Units on a scale | Standard Deviation 7.96 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | American Thoracic Society Questionnaire (ATSQ) | 16.08 Units on a scale | Standard Deviation 7.96 |
Secondary
Anabasine
A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Anabasine | 92.69 ng/mL | Standard Deviation 155.35 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Anabasine | 56.60 ng/mL | Standard Deviation 97.03 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Anabasine | 71.45 ng/mL | Standard Deviation 98.16 |
| Usual Brand Cigarette Phase (Women) | Anabasine | 76.19 ng/mL | Standard Deviation 92.95 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Anabasine | 72.90 ng/mL | Standard Deviation 107.13 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Anabasine | 65.61 ng/mL | Standard Deviation 83.24 |
Secondary
Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)
Evaluation of the perceived outcomes of cigarette or electronic cigarette use collected at the end of each phase for male and female participants. Range 0 to 9, with larger values indicating greater perceived negative consequences of cigarette use
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 4.56 Units on a scale | Standard Deviation 1.22 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 3.68 Units on a scale | Standard Deviation 1.25 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 3.54 Units on a scale | Standard Deviation 1.34 |
| Usual Brand Cigarette Phase (Women) | Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 4.61 Units on a scale | Standard Deviation 1.25 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 3.70 Units on a scale | Standard Deviation 1.7 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) | 3.72 Units on a scale | Standard Deviation 1.84 |
Secondary
Electronic Cigarette Sessions Per Day
Study electronic cigarette use measured by the mean number of sessions per day during each phase for male and female participants.
Time frame: 2 weeks
Population: Electronic cigarette sessions per day were not assessed during the Usual Brand Cigarette phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Electronic Cigarette Sessions Per Day | 11.32 Sessions per day | Standard Deviation 9.49 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Electronic Cigarette Sessions Per Day | 10.33 Sessions per day | Standard Deviation 8.93 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Electronic Cigarette Sessions Per Day | 10.78 Sessions per day | Standard Deviation 9.28 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Electronic Cigarette Sessions Per Day | 10.84 Sessions per day | Standard Deviation 10.84 |
Secondary
Fagerström Test for Cigarette Dependence (FTCD)
Evaluation of cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 10, with higher values indicating greater cigarette dependence
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Fagerström Test for Cigarette Dependence (FTCD) | 4.54 Units on a scale | Standard Deviation 2.09 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Fagerström Test for Cigarette Dependence (FTCD) | 3.71 Units on a scale | Standard Deviation 2.05 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Fagerström Test for Cigarette Dependence (FTCD) | 3.67 Units on a scale | Standard Deviation 2.07 |
| Usual Brand Cigarette Phase (Women) | Fagerström Test for Cigarette Dependence (FTCD) | 4.7 Units on a scale | Standard Deviation 2.02 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Fagerström Test for Cigarette Dependence (FTCD) | 3.97 Units on a scale | Standard Deviation 2.28 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Fagerström Test for Cigarette Dependence (FTCD) | 3.88 Units on a scale | Standard Deviation 1.85 |
Secondary
Implicit Association Test (IAT)
Evaluation of implicit cigarette or electronic cigarette liking collected at the end of each phase for male and female participants. Range: -1 to 1, with more negative values indicating a more negative attitude toward the cigarette product
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Implicit Association Test (IAT) | -0.29 Units on a scale | Standard Deviation 0.53 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Implicit Association Test (IAT) | -0.17 Units on a scale | Standard Deviation 0.48 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Implicit Association Test (IAT) | -0.08 Units on a scale | Standard Deviation 0.5 |
| Usual Brand Cigarette Phase (Women) | Implicit Association Test (IAT) | -0.32 Units on a scale | Standard Deviation 0.62 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Implicit Association Test (IAT) | -0.15 Units on a scale | Standard Deviation 0.4 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Implicit Association Test (IAT) | -0.25 Units on a scale | Standard Deviation 0.49 |
Secondary
Minnesota Nicotine Withdrawal Scale-Revised (MNWS)
Evaluation of nicotine withdrawal symptoms collected at the end of each phase for male and female participants. Range 0 to 60, with higher scores indicating greater nicotine withdrawal
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 27.01 Units on a scale | Standard Deviation 7.98 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 27.02 Units on a scale | Standard Deviation 7.99 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 26.04 Units on a scale | Standard Deviation 7.62 |
| Usual Brand Cigarette Phase (Women) | Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 28.81 Units on a scale | Standard Deviation 9.09 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 29.77 Units on a scale | Standard Deviation 9.77 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Minnesota Nicotine Withdrawal Scale-Revised (MNWS) | 28.08 Units on a scale | Standard Deviation 7.99 |
Secondary
Nicotelline
A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Nicotelline | 0.64 ng/mL | Standard Error 4.53 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Nicotelline | 0.38 ng/mL | Standard Error 2.05 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Nicotelline | 0.42 ng/mL | Standard Error 2.92 |
| Usual Brand Cigarette Phase (Women) | Nicotelline | 1.63 ng/mL | Standard Error 7.98 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Nicotelline | 2.22 ng/mL | Standard Error 8.42 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Nicotelline | 1.08 ng/mL | Standard Error 3.73 |
Secondary
Penn State Electronic Cigarette Dependence Index (PSECDI)
Evaluation of electronic cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 20, with higher scores indicating greater electronic cigarette dependence
Time frame: 2 weeks
Population: The PSECDI questionnaire was not administered during the Usual Brand Cigarette phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Penn State Electronic Cigarette Dependence Index (PSECDI) | 7.78 Units on a scale | Standard Deviation 4.08 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Penn State Electronic Cigarette Dependence Index (PSECDI) | 7.75 Units on a scale | Standard Deviation 3.97 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Penn State Electronic Cigarette Dependence Index (PSECDI) | 8.87 Units on a scale | Standard Deviation 4.32 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Penn State Electronic Cigarette Dependence Index (PSECDI) | 8.99 Units on a scale | Standard Deviation 4.36 |
Secondary
Perceived Health Risk Questionnaire (PHRQ)
Evaluation of participants' beliefs about their risks of developing health conditions from cigarettes or electronic cigarette collected at the end of each phase for male and female participants. Range 1-10, with higher values indicating greater perceived risk of negative health outcomes.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Perceived Health Risk Questionnaire (PHRQ) | 8.15 Units on a scale | Standard Deviation 2.18 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Perceived Health Risk Questionnaire (PHRQ) | 8.35 Units on a scale | Standard Deviation 2.22 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Perceived Health Risk Questionnaire (PHRQ) | 8.43 Units on a scale | Standard Deviation 2.06 |
| Usual Brand Cigarette Phase (Women) | Perceived Health Risk Questionnaire (PHRQ) | 9.05 Units on a scale | Standard Deviation 1.99 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Perceived Health Risk Questionnaire (PHRQ) | 9.21 Units on a scale | Standard Deviation 1.79 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Perceived Health Risk Questionnaire (PHRQ) | 9.23 Units on a scale | Standard Deviation 2.03 |
Secondary
Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg)
Evaluation of negative affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater negative affect
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 16.43 Units on a scale | Standard Deviation 7.31 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 16.22 Units on a scale | Standard Deviation 6.94 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 15.53 Units on a scale | Standard Deviation 6.89 |
| Usual Brand Cigarette Phase (Women) | Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 17.19 Units on a scale | Standard Deviation 7.09 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 17.73 Units on a scale | Standard Deviation 8.06 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) | 16.07 Units on a scale | Standard Deviation 6.3 |
Secondary
Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos)
Evaluation of positive affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater positive affect
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 32.30 Units on a scale | Standard Deviation 8.56 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 31.12 Units on a scale | Standard Deviation 9.25 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 32.82 Units on a scale | Standard Deviation 9.69 |
| Usual Brand Cigarette Phase (Women) | Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 32.80 Units on a scale | Standard Deviation 9.4 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 31.65 Units on a scale | Standard Deviation 9.09 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) | 33.03 Units on a scale | Standard Deviation 8.76 |
Secondary
Product Evaluation Scales (PES)
Evaluation of explicit cigarette or electronic cigarette product liking collected at the end of each phase for male and female participants. Range 1-7, with higher values indicating more unpleasant ratings.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Product Evaluation Scales (PES) | 4.33 Units on a scale | Standard Deviation 0.98 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Product Evaluation Scales (PES) | 3.30 Units on a scale | Standard Deviation 0.98 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Product Evaluation Scales (PES) | 3.44 Units on a scale | Standard Deviation 1.04 |
| Usual Brand Cigarette Phase (Women) | Product Evaluation Scales (PES) | 4.51 Units on a scale | Standard Deviation 1.12 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Product Evaluation Scales (PES) | 3.42 Units on a scale | Standard Deviation 1.17 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Product Evaluation Scales (PES) | 3.73 Units on a scale | Standard Deviation 1.35 |
Secondary
Purchase Task Breakpoint Measure
Evaluation of the Purchase Task Breakpoint measure (first price at which consumption goes to zero, i.e., unwilling to pay) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.05 - 251, dollars per cigarette or per electronic cigarette puff with higher values indicating the willingness to smoke/vape at a higher price.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Purchase Task Breakpoint Measure | 13.67 $/cigarette or $/e-cigarette puff | Standard Deviation 22.12 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Breakpoint Measure | 7.06 $/cigarette or $/e-cigarette puff | Standard Deviation 16.97 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Breakpoint Measure | 4.65 $/cigarette or $/e-cigarette puff | Standard Deviation 9.69 |
| Usual Brand Cigarette Phase (Women) | Purchase Task Breakpoint Measure | 14.25 $/cigarette or $/e-cigarette puff | Standard Deviation 33.22 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Breakpoint Measure | 5.73 $/cigarette or $/e-cigarette puff | Standard Deviation 10.64 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Breakpoint Measure | 7.44 $/cigarette or $/e-cigarette puff | Standard Deviation 16.92 |
Secondary
Purchase Task Demand Intensity Measure
Evaluation of the Purchase Task Demand Intensity measure (consumption at the lowest price) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 1 - 351, the number of cigarettes or electronic cigarette puffs with higher values indicating an intension to smoke/vape more when the price is set as 0
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Purchase Task Demand Intensity Measure | 20.52 # of cigarettes or e-cigarette puffs | Standard Deviation 14.37 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Demand Intensity Measure | 70.05 # of cigarettes or e-cigarette puffs | Standard Deviation 69.59 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Demand Intensity Measure | 59.08 # of cigarettes or e-cigarette puffs | Standard Deviation 51.94 |
| Usual Brand Cigarette Phase (Women) | Purchase Task Demand Intensity Measure | 19.05 # of cigarettes or e-cigarette puffs | Standard Deviation 13.14 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Demand Intensity Measure | 48.06 # of cigarettes or e-cigarette puffs | Standard Deviation 43.06 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Demand Intensity Measure | 60.39 # of cigarettes or e-cigarette puffs | Standard Deviation 56.06 |
Secondary
Purchase Task Elasticity of Demand Measure
Evaluation of the Purchase Task Elasticity of Demand measure (sensitivity of product consumption to increases in cost) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.0001 - 2.69, the elasticity of the demand for cigarettes or electronic cigarette puffs, with higher values indicating a greater sensitivity in reducing the consumption in response to the price increases
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Purchase Task Elasticity of Demand Measure | 0.0070 % change quantity/% change price | Standard Deviation 0.004 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Elasticity of Demand Measure | 0.0130 % change quantity/% change price | Standard Deviation 0.0057 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Elasticity of Demand Measure | 0.0177 % change quantity/% change price | Standard Deviation 0.0068 |
| Usual Brand Cigarette Phase (Women) | Purchase Task Elasticity of Demand Measure | 0.008 % change quantity/% change price | Standard Deviation 0.004 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Elasticity of Demand Measure | 0.026 % change quantity/% change price | Standard Deviation 0.009 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Elasticity of Demand Measure | 0.0298 % change quantity/% change price | Standard Deviation 0.009 |
Secondary
Purchase Task Omax Measure
Evaluation of the Purchase Task Omax measure (maximum financial expenditure on the product) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.03 - 1001, the maximum expenditure in dollars on cigarettes or electronic cigarette puffs with higher values indicating greater expenditure
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Purchase Task Omax Measure | 17.96 max spent $ on cigarettes or e-cig puffs | Standard Deviation 22.51 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Omax Measure | 24.74 max spent $ on cigarettes or e-cig puffs | Standard Deviation 72.92 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Omax Measure | 11.73 max spent $ on cigarettes or e-cig puffs | Standard Deviation 13.09 |
| Usual Brand Cigarette Phase (Women) | Purchase Task Omax Measure | 35.40 max spent $ on cigarettes or e-cig puffs | Standard Deviation 127.18 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Omax Measure | 13.51 max spent $ on cigarettes or e-cig puffs | Standard Deviation 23.2 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Omax Measure | 19.94 max spent $ on cigarettes or e-cig puffs | Standard Deviation 65.14 |
Secondary
Purchase Task Pmax Measure
Evaluation of the Purchase Task Pmax measure (price at which expenditure is maximized) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.01 - 1001, the price of the cigarette or electronic cigarette puffs when the Omax is reached
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Purchase Task Pmax Measure | 4.64 US Dollars per cigarette or per electron | Standard Deviation 7.82 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Pmax Measure | 2.86 US Dollars per cigarette or per electron | Standard Deviation 7.97 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Purchase Task Pmax Measure | 1.65 US Dollars per cigarette or per electron | Standard Deviation 3.53 |
| Usual Brand Cigarette Phase (Women) | Purchase Task Pmax Measure | 17.93 US Dollars per cigarette or per electron | Standard Deviation 114.14 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Pmax Measure | 2.36 US Dollars per cigarette or per electron | Standard Deviation 5.01 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Purchase Task Pmax Measure | 3.39 US Dollars per cigarette or per electron | Standard Deviation 8.39 |
Secondary
Questionnaire of Smoking Urges-Brief (QSU-Brief)
Evaluation of the craving to smoke cigarettes collected at the end of each phase for male and female participants. Range 1 to 10, with higher values indicating greater urge to smoke
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Questionnaire of Smoking Urges-Brief (QSU-Brief) | 4.16 Units on a scale | Standard Deviation 2.57 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Questionnaire of Smoking Urges-Brief (QSU-Brief) | 3.35 Units on a scale | Standard Deviation 2.71 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Questionnaire of Smoking Urges-Brief (QSU-Brief) | 3.26 Units on a scale | Standard Deviation 2.83 |
| Usual Brand Cigarette Phase (Women) | Questionnaire of Smoking Urges-Brief (QSU-Brief) | 4.25 Units on a scale | Standard Deviation 2.92 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Questionnaire of Smoking Urges-Brief (QSU-Brief) | 3.43 Units on a scale | Standard Deviation 3.04 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Questionnaire of Smoking Urges-Brief (QSU-Brief) | 2.80 Units on a scale | Standard Deviation 2.71 |
Secondary
Smartphone Daily Measures of Nicotine Dependence Symptoms
Evaluation of mean nicotine dependence symptoms collected daily during each phase. Range 1 to 5, with higher values indicating greater nicotine dependence symptoms
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Smartphone Daily Measures of Nicotine Dependence Symptoms | 2.40 Units on a scale | Standard Deviation 0.35 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Smartphone Daily Measures of Nicotine Dependence Symptoms | 2.42 Units on a scale | Standard Deviation 0.48 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Smartphone Daily Measures of Nicotine Dependence Symptoms | 2.34 Units on a scale | Standard Deviation 0.42 |
| Usual Brand Cigarette Phase (Women) | Smartphone Daily Measures of Nicotine Dependence Symptoms | 2.44 Units on a scale | Standard Deviation 0.33 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Smartphone Daily Measures of Nicotine Dependence Symptoms | 2.53 Units on a scale | Standard Deviation 0.37 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Smartphone Daily Measures of Nicotine Dependence Symptoms | 2.42 Units on a scale | Standard Deviation 0.34 |
Secondary
Total Nicotine Equivalents (TNE)
A measure of nicotine exposure, calculated as the sum of total nicotine, cotinine, 3'-hydroxycotinine, and nicotine N-oxide excreted in urine, collected at the end of each phase for male and female participants.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette Phase (Men) | Total Nicotine Equivalents (TNE) | 42.01 ng/mL | Standard Deviation 37.4 |
| Placebo Standardized Research Electronic Cigarette Phase (Men) | Total Nicotine Equivalents (TNE) | 30.98 ng/mL | Standard Deviation 30.12 |
| Nicotine Standardized Research Electronic Cigarette Phase (Men) | Total Nicotine Equivalents (TNE) | 39.97 ng/mL | Standard Deviation 36.44 |
| Usual Brand Cigarette Phase (Women) | Total Nicotine Equivalents (TNE) | 41.19 ng/mL | Standard Deviation 33.44 |
| Placebo Standardized Research Electronic Cigarette Phase (Women) | Total Nicotine Equivalents (TNE) | 39.46 ng/mL | Standard Deviation 38.8 |
| Nicotine Standardized Research Electronic Cigarette Phase (Women) | Total Nicotine Equivalents (TNE) | 41.75 ng/mL | Standard Deviation 42.11 |