Exposure to Toxic Agent, Nicotine Dependence, Smoking, Cigarette, Smoking, Tobacco
Conditions
Brief summary
The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.
Interventions
BEHAVIORALLow wattage E cigarette device
The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
BEHAVIORALHigh wattage E cigarette device
The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
BEHAVIORALUsual brand cigarette
The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
Sponsors
Ohio State University Comprehensive Cancer Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. smoke ≥5 cigarettes per day for the past year; 2. no quit attempt in the prior 3 months and no plan to quit in the next 3 months; 3. read, write, and speak in English; 4. report at least minimal interest in switching to an alternative product (\> "not at all" on a Likert scale); 5. never purchased or regularly used a tank system, mechanical mod, or advanced personal vaporizer EC, though previous use of cig-a-like devices will be allowed but not in the last 3 months; 6. plan to live in the local area for next year; and 7. have reliable means of transport. -
Exclusion criteria
1. \<18 years old; 2. unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data; 3. unstable or significant psychiatric conditions (past and stable conditions will be allowed); 4. history of cardiac event or distress within the past 3 months; and 5. currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Change From Conventional Cigarettes - Self Report | Week 4, Week 8, Week 12, Week 26, and Week 52 | Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes. |
| Complete Change From Conventional Cigarettes - Biochemically Verified | Week 4, Week 8, Week 12, Week 26, and Week 52 | Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Dependence | Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52 | Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence. |
| Cigarette Likeability/Preference | Baseline, Week 4, Week 12, Week 26, and Week 52 | Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief |
| EC Likeability/Preference | Week 4, Week 12 | EC modified-Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief. No results are reported for the Usual Brand Cigarette arm as the participants in this arm did not receive a study e-cigarette device and thus were not asked to respond to the e-cigarette modified cigarette evaluation scale items. |
| EC Abuse Liability | Week 4, Week 12, Week 26, and Week 52 | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of all three study products. 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. |
| Biomarker of Exposure - NNAL | Baseline, Week 4, Week 12 | Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol \[NNAL\] (pmol/mg creatinine) |
| Biomarker of Exposure - NNN | Baseline, Week 4, Week 12 | Presence of urinary \[pyridine-D4\]NNN (\[D4\]NNN) (pmol/mg creatinine) |
| Biomarker of Exposure - Total Nicotine Equivalents (TNE) | Baseline, Week 4, Week 12 | Sum of nicotine and metabolites in urine - Total Nicotine Equivalents (TNE) (nmol/mg creatinine) |
| Biomarker of Exposure - Nickel | Baseline, Week 4, Week 12 | Metals and metalloids in saliva - Nickel (ng/mL) |
| Biomarker of Exposure - Cadmium | Baseline, Week 4, Week 12 | Metals and metalloids in saliva - Cadmium (ng/mL) |
| Biomarker of Exposure - Lead | Baseline, Week 4, Week 12 | Metals and metalloids in saliva - Lead (ng/mL) |
| Biomarker of Exposure - 8-iso-PGF2a | Baseline, Week 4, Week 12 | Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine) |
| Biomarker of Effect - q-PADDA | Week 4, Week 12 | Data is shown as change in DNA damage from baseline. We calculated change in DNA damage in Transcribed (TS) and Non-transcribed strand (NTS) and added those data points to calculate the Total Change in DNA damage. Results are presented as change in number of DNA lesions per 10,000 base pairs. |
| Biomarker of Exposure - Nicotine Metabolite Ratio | Baseline, Week 4, Week 12 | Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine \[3HC\]/cotinine) |
| Biomarker of Exposure - PGEM | Baseline, Week 4, Week 12 | Urinary biomarker of oxidative stress and inflammation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTheodore Wagener, PhD
Ohio State Comprehensive Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Brand Cigarette Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study. | 105 |
| Low Wattage E Cigarette Device Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. | 133 |
| High Wattage E Cigarette Device High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. | 134 |
| Total | 372 |
Baseline characteristics
| Characteristic | Usual Brand Cigarette | Total | High Wattage E Cigarette Device | Low Wattage E Cigarette Device |
|---|---|---|---|---|
| Age, Continuous | 40.95 years STANDARD_DEVIATION 10.99 | 40.33 years STANDARD_DEVIATION 11.04 | 40.47 years STANDARD_DEVIATION 11.13 | 39.69 years STANDARD_DEVIATION 11.05 |
| Cigarettes Smoked per Day | 18.13 cigarettes per day STANDARD_DEVIATION 9.11 | 17.38 cigarettes per day STANDARD_DEVIATION 8.93 | 17.33 cigarettes per day STANDARD_DEVIATION 8.65 | 16.86 cigarettes per day STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 36 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 26 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 80 Participants | 294 Participants | 113 Participants | 101 Participants |
| Sex: Female, Male Female | 68 Participants | 233 Participants | 84 Participants | 81 Participants |
| Sex: Female, Male Male | 37 Participants | 139 Participants | 50 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 133 | 0 / 134 |
| other Total, other adverse events | 64 / 105 | 103 / 133 | 95 / 134 |
| serious Total, serious adverse events | 3 / 105 | 2 / 133 | 2 / 134 |
Outcome results
Primary
Complete Change From Conventional Cigarettes - Biochemically Verified
Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Time frame: Week 4, Week 8, Week 12, Week 26, and Week 52
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 26 | 5 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 12 | 0 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 4 | 0 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 8 | 0 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 52 | 4 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 12 | 15 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 4 | 10 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 8 | 16 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 26 | 18 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 52 | 11 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 52 | 8 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 26 | 6 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 4 | 9 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 12 | 11 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Biochemically Verified | Week 8 | 8 Participants |
Primary
Complete Change From Conventional Cigarettes - Self Report
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Time frame: Week 4, Week 8, Week 12, Week 26, and Week 52
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Self Report | Week 26 | 5 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Self Report | Week 12 | 0 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Self Report | Week 4 | 0 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Self Report | Week 8 | 0 Participants |
| Usual Brand Cigarette | Complete Change From Conventional Cigarettes - Self Report | Week 52 | 4 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 12 | 16 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 4 | 12 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 8 | 19 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 26 | 20 Participants |
| Low Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 52 | 13 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 52 | 8 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 26 | 9 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 4 | 10 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 12 | 16 Participants |
| High Wattage E Cigarette Device | Complete Change From Conventional Cigarettes - Self Report | Week 8 | 10 Participants |
Secondary
Biomarker of Effect - q-PADDA
Data is shown as change in DNA damage from baseline. We calculated change in DNA damage in Transcribed (TS) and Non-transcribed strand (NTS) and added those data points to calculate the Total Change in DNA damage.
Time frame: Week 4, Week 12
Secondary
Biomarker of Exposure - 8-iso-PGF2a
Urinary biomarker of oxidative stress and inflammation
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - Cadmium and Other Relevant Metals
Metals and metalloids in saliva
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - Lead and Other Relevant Metals
Metals and metalloids in saliva
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - Nickel and Other Relevant Metals
Metals and metalloids in saliva
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - Nicotine Metabolite Ratio
Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine \[3HC\]/cotinine)
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - NNAL
Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine)
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - NNN
Presence of urinary \[pyridine-D4\]NNN (\[D4\]NNN)
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - PGEM
Urinary biomarker of oxidative stress and inflammation
Time frame: Baseline, Week 4, Week 12
Secondary
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Sum of nicotine and metabolites in urine
Time frame: Baseline, Week 4, Week 12
Secondary
Cigarette Dependence
Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence.
Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52
Population: Participants who attended the study visit and responded to the items in the cigarette dependence scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | Cigarette Dependence | Week 1 | 48.45 score on a scale | Standard Deviation 6.96 |
| Usual Brand Cigarette | Cigarette Dependence | Week 12 | 48.03 score on a scale | Standard Deviation 7.78 |
| Usual Brand Cigarette | Cigarette Dependence | Week 8 | 48.27 score on a scale | Standard Deviation 8.06 |
| Usual Brand Cigarette | Cigarette Dependence | Baseline | 48.27 score on a scale | Standard Deviation 7.36 |
| Usual Brand Cigarette | Cigarette Dependence | Week 52 | 45.03 score on a scale | Standard Deviation 9.74 |
| Usual Brand Cigarette | Cigarette Dependence | Week 26 | 47.00 score on a scale | Standard Deviation 8.72 |
| Usual Brand Cigarette | Cigarette Dependence | Week 4 | 48.90 score on a scale | Standard Deviation 7.57 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Week 8 | 41.80 score on a scale | Standard Deviation 9.14 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Baseline | 47.63 score on a scale | Standard Deviation 7.51 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Week 1 | 43.71 score on a scale | Standard Deviation 8.7 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Week 4 | 41.89 score on a scale | Standard Deviation 9.74 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Week 12 | 41.32 score on a scale | Standard Deviation 9.67 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Week 26 | 40.67 score on a scale | Standard Deviation 11.27 |
| Low Wattage E Cigarette Device | Cigarette Dependence | Week 52 | 42.32 score on a scale | Standard Deviation 11.05 |
| High Wattage E Cigarette Device | Cigarette Dependence | Week 12 | 40.84 score on a scale | Standard Deviation 9.59 |
| High Wattage E Cigarette Device | Cigarette Dependence | Week 1 | 43.33 score on a scale | Standard Deviation 9.05 |
| High Wattage E Cigarette Device | Cigarette Dependence | Week 52 | 41.26 score on a scale | Standard Deviation 10.36 |
| High Wattage E Cigarette Device | Cigarette Dependence | Week 26 | 41.15 score on a scale | Standard Deviation 9.57 |
| High Wattage E Cigarette Device | Cigarette Dependence | Week 8 | 40.06 score on a scale | Standard Deviation 10.68 |
| High Wattage E Cigarette Device | Cigarette Dependence | Week 4 | 40.21 score on a scale | Standard Deviation 10.13 |
| High Wattage E Cigarette Device | Cigarette Dependence | Baseline | 47.45 score on a scale | Standard Deviation 8.79 |
Secondary
Cigarette Likeability/Preference
Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief
Time frame: Baseline, Week 4, Week 12, Week 26, and Week 52
Population: Participants who attended the study visit and answered the Cigarette Evaluation Scale items
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | Cigarette Likeability/Preference | Aversion - Week 4 | 2.25 score on a scale | Standard Deviation 0.9 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Aversion - Week 52 | 2.32 score on a scale | Standard Deviation 1 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Psychological Reward - Week 26 | 3.92 score on a scale | Standard Deviation 1.38 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Relief - Week 4 | 5.38 score on a scale | Standard Deviation 0.97 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Aversion - Baseline | 2.44 score on a scale | Standard Deviation 0.9 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Satisfaction - Week 26 | 4.47 score on a scale | Standard Deviation 1.51 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Satisfaction - Week 12 | 4.74 score on a scale | Standard Deviation 1.5 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Psychological Reward - Week 12 | 4.02 score on a scale | Standard Deviation 1.38 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Relief - Week 12 | 5.26 score on a scale | Standard Deviation 1.04 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Psychological Reward - Week 52 | 3.70 score on a scale | Standard Deviation 1.41 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Aversion - Week 12 | 2.35 score on a scale | Standard Deviation 1.01 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Relief - Baseline | 5.39 score on a scale | Standard Deviation 0.94 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Relief - Week 52 | 5.26 score on a scale | Standard Deviation 1.23 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Satisfaction - Week 52 | 4.27 score on a scale | Standard Deviation 1.5 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Satisfaction - Week 4 | 4.68 score on a scale | Standard Deviation 1.38 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Psychological Reward - Baseline | 4.30 score on a scale | Standard Deviation 1.13 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Relief - Week 26 | 5.23 score on a scale | Standard Deviation 1.08 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Psychological Reward - Week 4 | 4.18 score on a scale | Standard Deviation 1.19 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Satisfaction - Baseline | 4.68 score on a scale | Standard Deviation 1.17 |
| Usual Brand Cigarette | Cigarette Likeability/Preference | Aversion - Week 26 | 2.33 score on a scale | Standard Deviation 0.94 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 52 | 3.74 score on a scale | Standard Deviation 1.5 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Baseline | 5.01 score on a scale | Standard Deviation 1.27 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Baseline | 4.54 score on a scale | Standard Deviation 1.36 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Baseline | 2.13 score on a scale | Standard Deviation 0.8 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Baseline | 5.19 score on a scale | Standard Deviation 1.03 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 4 | 4.63 score on a scale | Standard Deviation 1.5 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 4 | 4.09 score on a scale | Standard Deviation 1.41 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 4 | 2.28 score on a scale | Standard Deviation 0.86 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 4 | 5.19 score on a scale | Standard Deviation 1.06 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 12 | 4.26 score on a scale | Standard Deviation 1.61 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 12 | 3.72 score on a scale | Standard Deviation 1.6 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 12 | 2.40 score on a scale | Standard Deviation 0.96 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 12 | 5.26 score on a scale | Standard Deviation 1.08 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 26 | 4.23 score on a scale | Standard Deviation 1.68 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 26 | 3.69 score on a scale | Standard Deviation 1.51 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 26 | 2.46 score on a scale | Standard Deviation 0.97 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 26 | 5.22 score on a scale | Standard Deviation 1.06 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 52 | 4.17 score on a scale | Standard Deviation 1.71 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 52 | 2.68 score on a scale | Standard Deviation 1.07 |
| Low Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 52 | 4.96 score on a scale | Standard Deviation 1.18 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 4 | 2.43 score on a scale | Standard Deviation 0.91 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Baseline | 4.13 score on a scale | Standard Deviation 1.49 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 26 | 3.53 score on a scale | Standard Deviation 1.42 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 4 | 3.62 score on a scale | Standard Deviation 1.5 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 52 | 4.84 score on a scale | Standard Deviation 1.16 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 26 | 2.36 score on a scale | Standard Deviation 0.92 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 4 | 4.39 score on a scale | Standard Deviation 1.4 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 52 | 2.42 score on a scale | Standard Deviation 0.89 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 26 | 4.89 score on a scale | Standard Deviation 1.09 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Baseline | 5.15 score on a scale | Standard Deviation 0.93 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Baseline | 4.81 score on a scale | Standard Deviation 1.28 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 12 | 3.61 score on a scale | Standard Deviation 1.49 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 52 | 4.37 score on a scale | Standard Deviation 1.55 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Week 12 | 2.45 score on a scale | Standard Deviation 0.95 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 12 | 4.27 score on a scale | Standard Deviation 1.68 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Aversion - Baseline | 2.16 score on a scale | Standard Deviation 0.89 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 12 | 4.88 score on a scale | Standard Deviation 1.14 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Relief - Week 4 | 4.88 score on a scale | Standard Deviation 1.1 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Psychological Reward - Week 52 | 3.59 score on a scale | Standard Deviation 1.57 |
| High Wattage E Cigarette Device | Cigarette Likeability/Preference | Satisfaction - Week 26 | 4.26 score on a scale | Standard Deviation 1.57 |
Secondary
EC Abuse Liability
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of all three study products. 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: Week 4, Week 12, Week 26, and Week 52
Population: For weeks 26 and 52, only participants who reported continued use of the study product were asked the items on the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | EC Abuse Liability | Satisfying - Week 26 | 79.73 score on a scale | Standard Deviation 20.66 |
| Usual Brand Cigarette | EC Abuse Liability | Enjoy - Week 12 | 79.49 score on a scale | Standard Deviation 21.03 |
| Usual Brand Cigarette | EC Abuse Liability | Want - Week 4 | 72.08 score on a scale | Standard Deviation 24.5 |
| Usual Brand Cigarette | EC Abuse Liability | Pleasurable - Week 26 | 76.58 score on a scale | Standard Deviation 22.94 |
| Usual Brand Cigarette | EC Abuse Liability | Pleasurable - Week 12 | 76.61 score on a scale | Standard Deviation 24.13 |
| Usual Brand Cigarette | EC Abuse Liability | Pleasurable - Week 4 | 77.42 score on a scale | Standard Deviation 21.82 |
| Usual Brand Cigarette | EC Abuse Liability | Enjoy - Week 26 | 71.91 score on a scale | Standard Deviation 27.88 |
| Usual Brand Cigarette | EC Abuse Liability | Satisfying - Week 12 | 82.12 score on a scale | Standard Deviation 19.83 |
| Usual Brand Cigarette | EC Abuse Liability | Satisfying - Week 52 | 77.96 score on a scale | Standard Deviation 21.63 |
| Usual Brand Cigarette | EC Abuse Liability | Like - Week 26 | 75.96 score on a scale | Standard Deviation 25.42 |
| Usual Brand Cigarette | EC Abuse Liability | Want - Week 26 | 72.69 score on a scale | Standard Deviation 26.08 |
| Usual Brand Cigarette | EC Abuse Liability | Enjoy - Week 52 | 74.36 score on a scale | Standard Deviation 21.95 |
| Usual Brand Cigarette | EC Abuse Liability | Satisfying - Week 4 | 82.17 score on a scale | Standard Deviation 17.77 |
| Usual Brand Cigarette | EC Abuse Liability | Pleasurable - Week 52 | 72.12 score on a scale | Standard Deviation 22.78 |
| Usual Brand Cigarette | EC Abuse Liability | Like - Week 52 | 71.52 score on a scale | Standard Deviation 24.39 |
| Usual Brand Cigarette | EC Abuse Liability | Want - Week 12 | 71.47 score on a scale | Standard Deviation 26.43 |
| Usual Brand Cigarette | EC Abuse Liability | Enjoy - Week 4 | 79.16 score on a scale | Standard Deviation 20.88 |
| Usual Brand Cigarette | EC Abuse Liability | Want - Week 52 | 67.56 score on a scale | Standard Deviation 23.57 |
| Usual Brand Cigarette | EC Abuse Liability | Like - Week 12 | 78.35 score on a scale | Standard Deviation 23.58 |
| Usual Brand Cigarette | EC Abuse Liability | Like - Week 4 | 78.95 score on a scale | Standard Deviation 21.61 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 52 | 73.18 score on a scale | Standard Deviation 27.13 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Want - Week 4 | 61.87 score on a scale | Standard Deviation 27.34 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Like - Week 4 | 67.78 score on a scale | Standard Deviation 25.36 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 4 | 68.35 score on a scale | Standard Deviation 24.31 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 4 | 65.95 score on a scale | Standard Deviation 24.63 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 4 | 63.88 score on a scale | Standard Deviation 23.08 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Want - Week 12 | 53.59 score on a scale | Standard Deviation 29.5 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Like - Week 12 | 60.71 score on a scale | Standard Deviation 30.64 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 12 | 60.78 score on a scale | Standard Deviation 30.26 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 12 | 60.27 score on a scale | Standard Deviation 30.23 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 12 | 57.13 score on a scale | Standard Deviation 29.77 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Want - Week 26 | 60.53 score on a scale | Standard Deviation 20.04 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Like - Week 26 | 66.53 score on a scale | Standard Deviation 23.86 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 26 | 68.27 score on a scale | Standard Deviation 18.79 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 26 | 70.20 score on a scale | Standard Deviation 19.39 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 26 | 68.73 score on a scale | Standard Deviation 20.65 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Want - Week 52 | 64.55 score on a scale | Standard Deviation 24.79 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Like - Week 52 | 74.09 score on a scale | Standard Deviation 24.09 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 52 | 71.00 score on a scale | Standard Deviation 26.65 |
| Low Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 52 | 74.82 score on a scale | Standard Deviation 25.42 |
| High Wattage E Cigarette Device | EC Abuse Liability | Like - Week 4 | 69.44 score on a scale | Standard Deviation 24.06 |
| High Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 26 | 61.59 score on a scale | Standard Deviation 24.79 |
| High Wattage E Cigarette Device | EC Abuse Liability | Like - Week 12 | 67.30 score on a scale | Standard Deviation 26.87 |
| High Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 52 | 65.00 score on a scale | Standard Deviation 17.7 |
| High Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 26 | 60.79 score on a scale | Standard Deviation 24.73 |
| High Wattage E Cigarette Device | EC Abuse Liability | Want - Week 12 | 60.45 score on a scale | Standard Deviation 26.85 |
| High Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 52 | 61.08 score on a scale | Standard Deviation 19.38 |
| High Wattage E Cigarette Device | EC Abuse Liability | Want - Week 52 | 49.23 score on a scale | Standard Deviation 29.38 |
| High Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 4 | 65.28 score on a scale | Standard Deviation 23.28 |
| High Wattage E Cigarette Device | EC Abuse Liability | Want - Week 4 | 60.43 score on a scale | Standard Deviation 25.04 |
| High Wattage E Cigarette Device | EC Abuse Liability | Like - Week 52 | 67.46 score on a scale | Standard Deviation 17.28 |
| High Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 4 | 67.13 score on a scale | Standard Deviation 24.79 |
| High Wattage E Cigarette Device | EC Abuse Liability | Want - Week 26 | 50.23 score on a scale | Standard Deviation 22.95 |
| High Wattage E Cigarette Device | EC Abuse Liability | Satisfying - Week 12 | 62.91 score on a scale | Standard Deviation 27.94 |
| High Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 4 | 67.83 score on a scale | Standard Deviation 24.41 |
| High Wattage E Cigarette Device | EC Abuse Liability | Like - Week 26 | 67.33 score on a scale | Standard Deviation 24.79 |
| High Wattage E Cigarette Device | EC Abuse Liability | Pleasurable - Week 12 | 65.33 score on a scale | Standard Deviation 27.96 |
| High Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 52 | 65.54 score on a scale | Standard Deviation 20.41 |
| High Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 26 | 65.36 score on a scale | Standard Deviation 25.56 |
| High Wattage E Cigarette Device | EC Abuse Liability | Enjoy - Week 12 | 66.96 score on a scale | Standard Deviation 26.59 |
Secondary
EC Likeability/Preference
EC modified-Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief. No results are reported for the Usual Brand Cigarette arm as the participants in this arm did not receive a study e-cigarette device and thus were not asked to respond to the e-cigarette modified cigarette evaluation scale items.
Time frame: Week 4, Week 12
Population: Participants who attended the study visit and answered the EC modified Cigarette Evaluation Scale items
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | EC Likeability/Preference | Satisfaction - Week 4 | 4.67 score on a scale | Standard Deviation 1.28 |
| Usual Brand Cigarette | EC Likeability/Preference | Psychological Reward - Week 4 | 2.93 score on a scale | Standard Deviation 1.26 |
| Usual Brand Cigarette | EC Likeability/Preference | Aversion - Week 4 | 1.48 score on a scale | Standard Deviation 0.6 |
| Usual Brand Cigarette | EC Likeability/Preference | Relief - Week 4 | 4.21 score on a scale | Standard Deviation 1.4 |
| Usual Brand Cigarette | EC Likeability/Preference | Satisfaction - Week 12 | 4.44 score on a scale | Standard Deviation 1.47 |
| Usual Brand Cigarette | EC Likeability/Preference | Psychological Reward - Week 12 | 2.73 score on a scale | Standard Deviation 1.41 |
| Usual Brand Cigarette | EC Likeability/Preference | Aversion - Week 12 | 1.40 score on a scale | Standard Deviation 0.55 |
| Usual Brand Cigarette | EC Likeability/Preference | Relief - Week 12 | 4.18 score on a scale | Standard Deviation 1.38 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Relief - Week 12 | 4.13 score on a scale | Standard Deviation 1.41 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Satisfaction - Week 4 | 4.63 score on a scale | Standard Deviation 1.5 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Satisfaction - Week 12 | 4.65 score on a scale | Standard Deviation 1.61 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Psychological Reward - Week 4 | 2.61 score on a scale | Standard Deviation 1.33 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Aversion - Week 12 | 1.46 score on a scale | Standard Deviation 0.72 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Aversion - Week 4 | 1.50 score on a scale | Standard Deviation 0.67 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Psychological Reward - Week 12 | 2.66 score on a scale | Standard Deviation 1.37 |
| Low Wattage E Cigarette Device | EC Likeability/Preference | Relief - Week 4 | 4.06 score on a scale | Standard Deviation 1.33 |