Tobacco Use
Conditions
Brief summary
This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.
Detailed description
The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).
Interventions
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks
Sponsors
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Within-subject design comparing smoking behavior when using menthol vs. non-menthol 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 | Menthol smoking (Week 2), Non-menthol smoking (Week 4) | Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Dependence | Week 4 (non-menthol) | Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence. |
| Quitting Interest | Week 4 (non-menthol) | Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item how important is quitting smoking to you? from 1 not at all to 10 extremely. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cigarette Brand Switching Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Cigarette Brand Switching |
|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non Hispanic Black | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non Hispanic White | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 3 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Total Number of Cigarettes Smoked
Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes
Time frame: Menthol smoking (Week 2), Non-menthol smoking (Week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cigarette Brand Switching | Total Number of Cigarettes Smoked | 2.2 cigarettes per day | Standard Deviation 3.2 |
Secondary
Nicotine Dependence
Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence.
Time frame: Week 4 (non-menthol)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cigarette Brand Switching | Nicotine Dependence | 36.8 score on a scale | Standard Deviation 10.9 |
Secondary
Quitting Interest
Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item how important is quitting smoking to you? from 1 not at all to 10 extremely.
Time frame: Week 4 (non-menthol)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cigarette Brand Switching | Quitting Interest | 5.4 units on a scale | Standard Deviation 2.5 |