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Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures

Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03502200
Enrollment
350
Registered
2018-04-18
Start date
2020-10-15
Completion date
2023-01-31
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Cigarette

Keywords

e-cigarettes, harm reduction, smoking behavior

Brief summary

The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.

Detailed description

There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).

Interventions

DEVICEJUUL

Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.

OTHERTreatment As Usual

Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

This study is a comparative randomized study.

Intervention model description

Participants will be assigned to one of two conditions randomly.

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* smoke ≥5 cigarettes per day for the past year * read, write, and speak in English * report at least minimal interest in switching to an alternative product (\> not at all on a Likert scale) * participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.

Exclusion criteria

* \<21 years old * report NRT use or making a quit attempt within the last 7 days * current daily use of an e-cigarette over last month. * unstable or significant medical condition such as respiratory, kidney, or liver disease * unstable or significant psychiatric conditions (past and stable conditions will be allowed) * history of cardiac event or distress within the past 6 months * currently pregnant, planning to become pregnant, or breastfeeding. * currently enrolled in a contradictory study. * cohabitates with a currently enrolled participant in the REACH study * reaction to using patch medication or adhesive tape * known allergy to propylene glycol or vegetable glycerin

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From CigarettesDaily for 12 weeksSelf-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence12 weeksIntent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.

Secondary

MeasureTime frameDescription
Sociodemographic Questionnaire - Employment StatusBaselineAssess participant employment status from the sociodemographic questionnaire
Cigarette/EC Dependency Scale12 weeksAssess e-cigarette and cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Drug Effects/Liking Questionnaire12 weeksAssess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)
Cigarette Purchase Task - BreakpointWeek 1 (Baseline)Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their own brand cigarette. Specifically they will be asked, How much would you be willing to pay for a puff of your usual cigarette brand?.
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)12 WeeksSmoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word cigarette with e-cigarette) for EC users. 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.
Minnesota Nicotine Withdrawal Scale12 WeeksAsses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).
Change in Motivation Rulers (Scale) From Baseline to Week 1212 WeeksAssess for changes in motivation from baseline to week 12 among participants who continue to smoke. Rulers including importance, confidence, and readiness to quit smoking (3-items total, with a scale ranging from 0 not at all important/confident/ready to 10 extremely important/confident/ready). Medians reported are change from baseline \[week 12 score - baseline score\] where negative values indicate a decrease in motivation over time and positive values indicate an increase in motivation over time.
Sociodemographic Questionnaire - AgeBaselineAssess participant age from the sociodemographic questionnaire
Sociodemographic Questionnaire - SexBaselineAssess participant sex from the sociodemographic questionnaire
Sociodemographic Questionnaire - Marital StatusBaselineAssess participant marital status from the sociodemographic questionnaire
Sociodemographic Questionnaire - EthnicityBaselineAssess participant ethnicity from the sociodemographic questionnaire
Sociodemographic Questionnaire - Socioeconomic StatusBaselineAssess participant socioeconomic status via yearly household income

Other

MeasureTime frameDescription
Tobacco Use History Questionnaire - Number of Smokers in the HouseholdWeek 1 (baseline)Assess number of smokers in the household with the tobacco use history questionnaire
Tobacco Use History Questionnaire - Cigarette Expectance EffectsWeek 1 (baseline)Assess cigarette expectance effects with the tobacco use history questionnaire
Tobacco Use History QuestionnaireWeek 1 (Baseline)Assess frequency of use all of nicotine/tobacco products including cigars, cigarillos, little cigars, smokeless tobacco, EC, and hookah.
Tobacco Use History Questionnaire - 24-hour Quit AttemptsWeek 1 (baseline)Assess number of previous 24-hour quit attempts with the tobacco use history questionnaire
Tobacco Use History Questionnaire - Years of SmokingWeek 1 (baseline)Assess years of smoking from the tobacco use history questionnaire
Tobacco Use History Questionnaire - Cigarettes Per DayWeek 1 (baseline)Assess average number of cigarettes per day with the tobacco use history questionnaire

Countries

United States

Participant flow

Participants by arm

ArmCount
E-cigarette
5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling. JUUL: Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
175
Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling. Treatment As Usual: Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
175
Total350

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudyDeath02
Overall StudyLost to Follow-up3638
Overall StudyStudy Team Decision11
Overall StudyWithdrawal by Subject57

Baseline characteristics

CharacteristicE-cigaretteTreatment As UsualTotal
Age, Continuous55.26 years
STANDARD_DEVIATION 12.66
54.19 years
STANDARD_DEVIATION 12.47
54.72 years
STANDARD_DEVIATION 12.56
Cigarettes Smoked per Day16.78 cigarettes per day
STANDARD_DEVIATION 8.16
17.41 cigarettes per day
STANDARD_DEVIATION 8.21
17.10 cigarettes per day
STANDARD_DEVIATION 8.18
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
170 Participants171 Participants341 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Sex: Female, Male
Female
107 Participants105 Participants212 Participants
Sex: Female, Male
Male
66 Participants68 Participants134 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1752 / 175
other
Total, other adverse events
93 / 17587 / 175
serious
Total, serious adverse events
18 / 17510 / 175

Outcome results

Primary

Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence

Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.

Time frame: 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-cigaretteProportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence22 Participants
Treatment As UsualProportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence17 Participants
Primary

Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes

Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.

Time frame: Daily for 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-cigaretteProportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes41 Participants
Treatment As UsualProportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes33 Participants
Secondary

Change in Motivation Rulers (Scale) From Baseline to Week 12

Assess for changes in motivation from baseline to week 12 among participants who continue to smoke. Rulers including importance, confidence, and readiness to quit smoking (3-items total, with a scale ranging from 0 not at all important/confident/ready to 10 extremely important/confident/ready). Medians reported are change from baseline \[week 12 score - baseline score\] where negative values indicate a decrease in motivation over time and positive values indicate an increase in motivation over time.

Time frame: 12 Weeks

Population: Participants who continued to smoke cigarettes at their week 12 visit and provided responses to both the baseline and 12 week motivation ruler questionnaire.

ArmMeasureGroupValue (MEDIAN)
E-cigaretteChange in Motivation Rulers (Scale) From Baseline to Week 12Importance0 score on a scale
E-cigaretteChange in Motivation Rulers (Scale) From Baseline to Week 12Readiness-0.5 score on a scale
E-cigaretteChange in Motivation Rulers (Scale) From Baseline to Week 12Confidence0 score on a scale
Treatment As UsualChange in Motivation Rulers (Scale) From Baseline to Week 12Readiness0 score on a scale
Treatment As UsualChange in Motivation Rulers (Scale) From Baseline to Week 12Importance0 score on a scale
Treatment As UsualChange in Motivation Rulers (Scale) From Baseline to Week 12Confidence0 score on a scale
Secondary

Cigarette/EC Dependency Scale

Assess e-cigarette and cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.

Time frame: 12 weeks

Population: Participants who completed their 12 week visit and provided responses to each item on the cigarette/e-cigarette dependency scale questionnaire.~Participants in the treatment as usual arm were not assessed with the e-cigarette dependence scale as it is only applicable to the e-cigarette arm.

ArmMeasureGroupValue (MEAN)Dispersion
E-cigaretteCigarette/EC Dependency ScaleCigarette Dependence Scale14.42 units on a scaleStandard Deviation 4.51
E-cigaretteCigarette/EC Dependency Scalee-Cigarette Dependence Scale12.63 units on a scaleStandard Deviation 4.99
Treatment As UsualCigarette/EC Dependency ScaleCigarette Dependence Scale14.11 units on a scaleStandard Deviation 4.6
Secondary

Cigarette Purchase Task - Breakpoint

Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their own brand cigarette. Specifically they will be asked, How much would you be willing to pay for a puff of your usual cigarette brand?.

Time frame: Week 1 (Baseline)

Population: Participants who completed the cigarette purchase task at baseline.

ArmMeasureValue (MEAN)Dispersion
E-cigaretteCigarette Purchase Task - Breakpoint2.62 DollarsStandard Deviation 11.16
Treatment As UsualCigarette Purchase Task - Breakpoint5.96 DollarsStandard Deviation 27.42
Secondary

Drug Effects/Liking Questionnaire

Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)

Time frame: 12 weeks

Population: Participants who responded to the drug effects liking questionnaire within 1 week of their week 12 visit.~Participants in the treatment as usual arm were not assessed with the e-cigarette drug effects and liking questionnaires as they are only applicable to the e-cigarette arm.

ArmMeasureGroupValue (MEAN)Dispersion
E-cigaretteDrug Effects/Liking QuestionnaireEffect from smoking cigarettes2.81 score on a scaleStandard Deviation 1.32
E-cigaretteDrug Effects/Liking QuestionnaireLiking of effect after smoking cigarettes3.16 score on a scaleStandard Deviation 1.17
E-cigaretteDrug Effects/Liking QuestionnaireEffect from vaping e-cigarette2.80 score on a scaleStandard Deviation 1.1
E-cigaretteDrug Effects/Liking QuestionnaireLiking of effect from vaping e-cigarette3.39 score on a scaleStandard Deviation 1.07
Treatment As UsualDrug Effects/Liking QuestionnaireEffect from smoking cigarettes3.20 score on a scaleStandard Deviation 1.3
Treatment As UsualDrug Effects/Liking QuestionnaireLiking of effect after smoking cigarettes2.97 score on a scaleStandard Deviation 1.23
Secondary

Minnesota Nicotine Withdrawal Scale

Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).

Time frame: 12 Weeks

Population: Participants who completed their 12 week visit

ArmMeasureGroupValue (MEAN)Dispersion
E-cigaretteMinnesota Nicotine Withdrawal ScaleMNWS1.24 score on a scaleStandard Deviation 1.01
E-cigaretteMinnesota Nicotine Withdrawal ScaleMNWS Craving1.98 score on a scaleStandard Deviation 1.54
Treatment As UsualMinnesota Nicotine Withdrawal ScaleMNWS1.38 score on a scaleStandard Deviation 1.07
Treatment As UsualMinnesota Nicotine Withdrawal ScaleMNWS Craving2.22 score on a scaleStandard Deviation 1.47
Secondary

Sociodemographic Questionnaire - Age

Assess participant age from the sociodemographic questionnaire

Time frame: Baseline

Population: Participants who completed the baseline survey; age was not collected for 4 participants

ArmMeasureValue (MEAN)Dispersion
E-cigaretteSociodemographic Questionnaire - Age55.26 yearsStandard Deviation 12.66
Treatment As UsualSociodemographic Questionnaire - Age54.19 yearsStandard Deviation 12.47
Secondary

Sociodemographic Questionnaire - Employment Status

Assess participant employment status from the sociodemographic questionnaire

Time frame: Baseline

Population: Participants who completed the baseline survey; employment data was not collected for 4 participants; 2 additional participants refused to answer the employment items

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteSociodemographic Questionnaire - Employment StatusSelf-employed11 Participants
E-cigaretteSociodemographic Questionnaire - Employment StatusHomemaker11 Participants
E-cigaretteSociodemographic Questionnaire - Employment StatusEmployed by other full-time for wages26 Participants
E-cigaretteSociodemographic Questionnaire - Employment StatusRetired30 Participants
E-cigaretteSociodemographic Questionnaire - Employment StatusOut of work17 Participants
E-cigaretteSociodemographic Questionnaire - Employment StatusUnable to work/Disabled69 Participants
E-cigaretteSociodemographic Questionnaire - Employment StatusEmployed by others part-time for wages8 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusUnable to work/Disabled60 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusEmployed by others part-time for wages12 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusEmployed by other full-time for wages32 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusSelf-employed13 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusOut of work21 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusHomemaker3 Participants
Treatment As UsualSociodemographic Questionnaire - Employment StatusRetired31 Participants
Secondary

Sociodemographic Questionnaire - Ethnicity

Assess participant ethnicity from the sociodemographic questionnaire

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteSociodemographic Questionnaire - EthnicityHispanic or Latino2 Participants
E-cigaretteSociodemographic Questionnaire - EthnicityNot Hispanic or Latino170 Participants
E-cigaretteSociodemographic Questionnaire - EthnicityUnknown or Not Reported3 Participants
Treatment As UsualSociodemographic Questionnaire - EthnicityHispanic or Latino2 Participants
Treatment As UsualSociodemographic Questionnaire - EthnicityNot Hispanic or Latino171 Participants
Treatment As UsualSociodemographic Questionnaire - EthnicityUnknown or Not Reported2 Participants
Secondary

Sociodemographic Questionnaire - Marital Status

Assess participant marital status from the sociodemographic questionnaire

Time frame: Baseline

Population: Participants who completed the baseline survey; marital status was not collected for 4 participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteSociodemographic Questionnaire - Marital StatusMarried55 Participants
E-cigaretteSociodemographic Questionnaire - Marital StatusNot married, but living with romantic partner16 Participants
E-cigaretteSociodemographic Questionnaire - Marital StatusRomantic partner (not living with)5 Participants
E-cigaretteSociodemographic Questionnaire - Marital StatusDivorced/Separated50 Participants
E-cigaretteSociodemographic Questionnaire - Marital StatusNever married and not in current romantic relationship24 Participants
E-cigaretteSociodemographic Questionnaire - Marital StatusWidowed23 Participants
Treatment As UsualSociodemographic Questionnaire - Marital StatusNever married and not in current romantic relationship25 Participants
Treatment As UsualSociodemographic Questionnaire - Marital StatusWidowed23 Participants
Treatment As UsualSociodemographic Questionnaire - Marital StatusMarried56 Participants
Treatment As UsualSociodemographic Questionnaire - Marital StatusDivorced/Separated46 Participants
Treatment As UsualSociodemographic Questionnaire - Marital StatusNot married, but living with romantic partner18 Participants
Treatment As UsualSociodemographic Questionnaire - Marital StatusRomantic partner (not living with)5 Participants
Secondary

Sociodemographic Questionnaire - Sex

Assess participant sex from the sociodemographic questionnaire

Time frame: Baseline

Population: Participants who completed the baseline survey; sex was not collected for 4 participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteSociodemographic Questionnaire - SexMale66 Participants
E-cigaretteSociodemographic Questionnaire - SexFemale107 Participants
Treatment As UsualSociodemographic Questionnaire - SexMale68 Participants
Treatment As UsualSociodemographic Questionnaire - SexFemale105 Participants
Secondary

Sociodemographic Questionnaire - Socioeconomic Status

Assess participant socioeconomic status via yearly household income

Time frame: Baseline

Population: Participants who completed the baseline survey; household income was not collected for 4 participants; 7 additional participants refused to answer the income item

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteSociodemographic Questionnaire - Socioeconomic Status<$35,000136 Participants
E-cigaretteSociodemographic Questionnaire - Socioeconomic Status≥$35,00034 Participants
Treatment As UsualSociodemographic Questionnaire - Socioeconomic Status<$35,000136 Participants
Treatment As UsualSociodemographic Questionnaire - Socioeconomic Status≥$35,00033 Participants
Secondary

Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)

Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word cigarette with e-cigarette) for EC users. 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: 12 Weeks

Population: Participants who completed their 12 week visit. Participants in the treatment as usual arm were not assessed with the e-cigarette QSU questionnaire as it is only applicable to the e-cigarette arm.~Participants in the e-cigarette arm were not assessed with the NRT QSU questionnaire as it is only applicable to the treatment as usual arm.

ArmMeasureGroupValue (MEAN)Dispersion
E-cigaretteTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Desire (cigarette)12.97 score on a scaleStandard Deviation 9.72
E-cigaretteTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Desire (e-cigarette)16.76 score on a scaleStandard Deviation 10.71
E-cigaretteTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Relief (e-cigarette)11.82 score on a scaleStandard Deviation 8.26
E-cigaretteTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Relief (cigarette)10.13 score on a scaleStandard Deviation 7.98
Treatment As UsualTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Relief (NRT)8.69 score on a scaleStandard Deviation 6.84
Treatment As UsualTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Desire (cigarette)13.66 score on a scaleStandard Deviation 10.38
Treatment As UsualTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Relief (cigarette)10.22 score on a scaleStandard Deviation 7.37
Treatment As UsualTiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)QSU Desire (NRT)10.56 score on a scaleStandard Deviation 8.41
Other Pre-specified

Tobacco Use History Questionnaire

Assess frequency of use all of nicotine/tobacco products including cigars, cigarillos, little cigars, smokeless tobacco, EC, and hookah.

Time frame: Week 1 (Baseline)

Population: Participants who completed the baseline survey

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteTobacco Use History QuestionnaireCigarilloLess than monthly8 Participants
E-cigaretteTobacco Use History QuestionnaireCigarDaily or almost daily1 Participants
E-cigaretteTobacco Use History QuestionnaireCigarilloNot at all151 Participants
E-cigaretteTobacco Use History QuestionnaireLittle CigarRefuse to answer/Don't know0 Participants
E-cigaretteTobacco Use History QuestionnaireCigarilloRefuse to answer/Don't know0 Participants
E-cigaretteTobacco Use History QuestionnaireCigarLess than daily, but at least once a week1 Participants
E-cigaretteTobacco Use History QuestionnaireLittle CigarDaily or almost daily2 Participants
E-cigaretteTobacco Use History Questionnairee-cigaretteDaily or almost daily2 Participants
E-cigaretteTobacco Use History QuestionnaireLittle CigarLess than daily, but at least once a week1 Participants
E-cigaretteTobacco Use History QuestionnaireCigarLess than weekly, but at least once a month2 Participants
E-cigaretteTobacco Use History QuestionnaireLittle CigarLess than weekly, but at least once a month0 Participants
E-cigaretteTobacco Use History QuestionnaireHookahNot at all172 Participants
E-cigaretteTobacco Use History QuestionnaireCigarLess than monthly11 Participants
E-cigaretteTobacco Use History QuestionnaireSmokeless TobaccoDaily or almost daily4 Participants
E-cigaretteTobacco Use History Questionnairee-cigaretteLess than weekly, but at least once a month13 Participants
E-cigaretteTobacco Use History QuestionnaireSmokeless TobaccoLess than daily, but at least once a week1 Participants
E-cigaretteTobacco Use History QuestionnaireCigarNot at all158 Participants
E-cigaretteTobacco Use History QuestionnaireSmokeless TobaccoLess than weekly, but at least once a month0 Participants
E-cigaretteTobacco Use History Questionnairee-cigaretteLess than monthly12 Participants
E-cigaretteTobacco Use History QuestionnaireSmokeless TobaccoLess than monthly2 Participants
E-cigaretteTobacco Use History QuestionnaireCigarRefuse to answer/Don't know0 Participants
E-cigaretteTobacco Use History QuestionnaireSmokeless TobaccoNot at all166 Participants
E-cigaretteTobacco Use History QuestionnaireLittle CigarNot at all165 Participants
E-cigaretteTobacco Use History QuestionnaireSmokeless TobaccoRefuse to answer/Don't know0 Participants
E-cigaretteTobacco Use History QuestionnaireCigarilloDaily or almost daily2 Participants
E-cigaretteTobacco Use History QuestionnaireHookahDaily or almost daily0 Participants
E-cigaretteTobacco Use History Questionnairee-cigaretteNot at all139 Participants
E-cigaretteTobacco Use History QuestionnaireHookahLess than daily, but at least once a week0 Participants
E-cigaretteTobacco Use History QuestionnaireCigarilloLess than daily, but at least once a week5 Participants
E-cigaretteTobacco Use History QuestionnaireHookahLess than weekly, but at least once a month0 Participants
E-cigaretteTobacco Use History QuestionnaireLittle CigarLess than monthly5 Participants
E-cigaretteTobacco Use History QuestionnaireHookahLess than monthly0 Participants
E-cigaretteTobacco Use History QuestionnaireCigarilloLess than weekly, but at least once a month7 Participants
E-cigaretteTobacco Use History Questionnairee-cigaretteRefuse to answer/Don't know1 Participants
E-cigaretteTobacco Use History QuestionnaireHookahRefuse to answer/Don't know1 Participants
E-cigaretteTobacco Use History Questionnairee-cigaretteLess than daily, but at least once a week6 Participants
Treatment As UsualTobacco Use History QuestionnaireHookahRefuse to answer/Don't know0 Participants
Treatment As UsualTobacco Use History Questionnairee-cigaretteLess than daily, but at least once a week2 Participants
Treatment As UsualTobacco Use History Questionnairee-cigaretteLess than weekly, but at least once a month7 Participants
Treatment As UsualTobacco Use History Questionnairee-cigaretteRefuse to answer/Don't know0 Participants
Treatment As UsualTobacco Use History QuestionnaireLittle CigarLess than monthly3 Participants
Treatment As UsualTobacco Use History QuestionnaireLittle CigarNot at all168 Participants
Treatment As UsualTobacco Use History Questionnairee-cigaretteDaily or almost daily2 Participants
Treatment As UsualTobacco Use History Questionnairee-cigaretteLess than monthly13 Participants
Treatment As UsualTobacco Use History Questionnairee-cigaretteNot at all149 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarDaily or almost daily0 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarLess than daily, but at least once a week1 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarLess than weekly, but at least once a month1 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarLess than monthly5 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarNot at all166 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarRefuse to answer/Don't know0 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarilloDaily or almost daily3 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarilloLess than daily, but at least once a week5 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarilloLess than weekly, but at least once a month2 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarilloLess than monthly9 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarilloNot at all153 Participants
Treatment As UsualTobacco Use History QuestionnaireCigarilloRefuse to answer/Don't know1 Participants
Treatment As UsualTobacco Use History QuestionnaireLittle CigarDaily or almost daily1 Participants
Treatment As UsualTobacco Use History QuestionnaireLittle CigarLess than daily, but at least once a week1 Participants
Treatment As UsualTobacco Use History QuestionnaireLittle CigarLess than weekly, but at least once a month0 Participants
Treatment As UsualTobacco Use History QuestionnaireLittle CigarRefuse to answer/Don't know0 Participants
Treatment As UsualTobacco Use History QuestionnaireSmokeless TobaccoDaily or almost daily1 Participants
Treatment As UsualTobacco Use History QuestionnaireSmokeless TobaccoLess than daily, but at least once a week4 Participants
Treatment As UsualTobacco Use History QuestionnaireSmokeless TobaccoLess than weekly, but at least once a month3 Participants
Treatment As UsualTobacco Use History QuestionnaireSmokeless TobaccoLess than monthly1 Participants
Treatment As UsualTobacco Use History QuestionnaireSmokeless TobaccoNot at all164 Participants
Treatment As UsualTobacco Use History QuestionnaireSmokeless TobaccoRefuse to answer/Don't know0 Participants
Treatment As UsualTobacco Use History QuestionnaireHookahDaily or almost daily0 Participants
Treatment As UsualTobacco Use History QuestionnaireHookahLess than daily, but at least once a week1 Participants
Treatment As UsualTobacco Use History QuestionnaireHookahLess than weekly, but at least once a month2 Participants
Treatment As UsualTobacco Use History QuestionnaireHookahLess than monthly2 Participants
Treatment As UsualTobacco Use History QuestionnaireHookahNot at all168 Participants
Other Pre-specified

Tobacco Use History Questionnaire - 24-hour Quit Attempts

Assess number of previous 24-hour quit attempts with the tobacco use history questionnaire

Time frame: Week 1 (baseline)

Population: Participants who completed the tobacco use history questionnaire at baseline

ArmMeasureValue (MEAN)Dispersion
E-cigaretteTobacco Use History Questionnaire - 24-hour Quit Attempts0.93 quit attemptsStandard Deviation 2.39
Treatment As UsualTobacco Use History Questionnaire - 24-hour Quit Attempts0.82 quit attemptsStandard Deviation 1.71
Other Pre-specified

Tobacco Use History Questionnaire - Cigarette Expectance Effects

Assess cigarette expectance effects with the tobacco use history questionnaire

Time frame: Week 1 (baseline)

Population: Participants who completed the baseline survey

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeAgree106 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Refuse to answer / Don't know0 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeRefuse to answer / Don't know0 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downDisagree a little12 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodDisagree49 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Disagree a little9 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodDisagree a little18 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downAgree a little22 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodAgree a little45 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomDisagree26 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodAgree61 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightAgree a little16 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodRefuse to answer / Don't know0 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downRefuse to answer / Don't know3 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldDisagree92 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomDisagree a little23 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldDisagree a little15 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeDisagree18 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldAgree a little28 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Agree a little23 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldAgree36 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeDisagree a little5 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldRefuse to answer / Don't know2 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomAgree a little28 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeDisagree31 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeAgree a little26 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeDisagree a little15 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Disagree12 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeAgree a little30 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeAgree124 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeAgree96 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomAgree95 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeRefuse to answer / Don't know1 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeRefuse to answer / Don't know0 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousDisagree a little3 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Agree129 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousAgree a little32 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeDisagree25 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousAgree125 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomRefuse to answer / Don't know1 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousRefuse to answer / Don't know0 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeDisagree a little14 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightDisagree110 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousDisagree13 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightDisagree a little17 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeAgree a little28 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightAgree26 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downDisagree103 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightRefuse to answer / Don't know4 Participants
E-cigaretteTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downAgree33 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightRefuse to answer / Don't know3 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeRefuse to answer / Don't know1 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightDisagree a little15 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Disagree19 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Disagree a little1 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Agree a little24 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Agree129 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm angry, a cigarette can help calm me down.Refuse to answer / Don't know0 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomDisagree27 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomDisagree a little12 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomAgree a little33 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomAgree101 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes are good for dealing with boredomRefuse to answer / Don't know0 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downDisagree100 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downDisagree a little10 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downAgree a little23 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downAgree37 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking keeps my weight downRefuse to answer / Don't know3 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeDisagree16 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeDisagree a little8 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeAgree a little17 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeAgree132 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm upset with someone, a cigarette helps me copeRefuse to answer / Don't know0 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeDisagree28 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeDisagree a little10 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeAgree a little28 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeAgree107 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsIf I have nothing to do, a smoke can help kill timeRefuse to answer / Don't know0 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodDisagree48 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodDisagree a little23 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodAgree a little36 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodAgree66 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm feeling down, a cigarette can really make me feel goodRefuse to answer / Don't know0 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldDisagree85 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldDisagree a little15 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldAgree a little23 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldAgree47 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsCigarettes keep me from eating more than I shouldRefuse to answer / Don't know3 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeDisagree42 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeDisagree a little12 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeAgree a little23 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsWhen I'm alone, a cigarette can help me pass the timeAgree95 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousDisagree15 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousDisagree a little10 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousAgree a little21 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousAgree126 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking cigarettes calms me down when I feel nervousRefuse to answer / Don't know1 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightDisagree109 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightAgree a little17 Participants
Treatment As UsualTobacco Use History Questionnaire - Cigarette Expectance EffectsSmoking helps me control my weightAgree29 Participants
Other Pre-specified

Tobacco Use History Questionnaire - Cigarettes Per Day

Assess average number of cigarettes per day with the tobacco use history questionnaire

Time frame: Week 1 (baseline)

Population: Participants who completed the tobacco use history questionnaire at baseline

ArmMeasureValue (MEAN)Dispersion
E-cigaretteTobacco Use History Questionnaire - Cigarettes Per Day16.78 cigarettes per dayStandard Deviation 8.16
Treatment As UsualTobacco Use History Questionnaire - Cigarettes Per Day17.41 cigarettes per dayStandard Deviation 8.21
Other Pre-specified

Tobacco Use History Questionnaire - Number of Smokers in the Household

Assess number of smokers in the household with the tobacco use history questionnaire

Time frame: Week 1 (baseline)

Population: Participants who completed the tobacco use history questionnaire at baseline

ArmMeasureValue (MEAN)Dispersion
E-cigaretteTobacco Use History Questionnaire - Number of Smokers in the Household1.59 peopleStandard Deviation 0.84
Treatment As UsualTobacco Use History Questionnaire - Number of Smokers in the Household1.53 peopleStandard Deviation 0.83
Other Pre-specified

Tobacco Use History Questionnaire - Years of Smoking

Assess years of smoking from the tobacco use history questionnaire

Time frame: Week 1 (baseline)

Population: Participants who completed the tobacco use history questionnaire at baseline

ArmMeasureValue (MEAN)Dispersion
E-cigaretteTobacco Use History Questionnaire - Years of Smoking34.15 yearsStandard Deviation 12.99
Treatment As UsualTobacco Use History Questionnaire - Years of Smoking31.59 yearsStandard Deviation 14.45

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026