Tobacco Use
Conditions
Brief summary
This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.
Detailed description
The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.
Interventions
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
OTHERE-cigarette Flavor
Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Sponsors
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 or older * Able to read English * Cigarette smoker
Exclusion criteria
* Seeking smoking cessation treatment * Serious psychiatric or medical condition * Use of other drugs * Unable or unwilling to complete study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Cigarettes Smoked | Week 6 | Self-reported total number of cigarettes smoked per day (Timeline Follow Back) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-cigarette Use | Week 6 | Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back) |
| Tobacco Product Satisfaction | Week 6 | Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction |
| Motivation to Quit Smoking | Week 6 | Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit |
| Nicotine Dependence | Week 6 | Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Menthol E-cigarette Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes | 3 |
| Tobacco E-cigarette Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Tobacco E-cigarette | Total | Menthol E-cigarette |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Continuous | — | 43.3 years STANDARD_DEVIATION 13.6 | 43.3 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | — | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | — | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | — | 2 Participants | 2 Participants |
| Region of Enrollment United States | — | 3 participants | 3 participants |
| Sex: Female, Male Female | — | 1 Participants | 1 Participants |
| Sex: Female, Male Male | — | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Total Number of Cigarettes Smoked
Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
Time frame: Week 6
Population: No participants were enrolled in the tobacco e-cigarette condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol E-cigarette | Total Number of Cigarettes Smoked | 19 cigarettes per day | Standard Deviation 16 |
Secondary
E-cigarette Use
Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)
Time frame: Week 6
Population: Analyses were not conducted for this outcome examining use by e-cigarette flavor condition because no participants were enrolled in the tobacco e-cigarette condition.
Secondary
Motivation to Quit Smoking
Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit
Time frame: Week 6
Population: No participants were enrolled in the tobacco e-cigarette condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol E-cigarette | Motivation to Quit Smoking | 7.7 units on a scale | Standard Deviation 2.1 |
Secondary
Nicotine Dependence
Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence
Time frame: Week 6
Population: No participants were enrolled in the tobacco e-cigarette condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol E-cigarette | Nicotine Dependence | 3.8 score on a scale | Standard Deviation 1.1 |
Secondary
Tobacco Product Satisfaction
Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction
Time frame: Week 6
Population: No participants were enrolled in the tobacco e-cigarette condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol E-cigarette | Tobacco Product Satisfaction | 1.7 units on a scale | Standard Deviation 1.6 |