Tobacco Use Disorder
Conditions
Brief summary
The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes
Interventions
OTHERmenthol flavored e-cigarette
menthol flavored e-cigarette
OTHERtobacco flavored e-cigarette
tobacco flavored e-cigarette
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Self identify as African American * smoke primarily menthol cigarettes * be between the ages of 18 and 64 * smoke a minimum number of cigarettes per day * agree to abstain from menthol cigarettes for an 8 week period
Exclusion criteria
* current unstable medical / psychiatric condition * regular use any form of nicotine or tobacco other than cigarettes * are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cigarettes Smoked Per Day | 1 month | Number of cigarettes smoked per day as self-reported on tobacco diary |
| Number of E-cigarette Puffs Used Per Day | 1 month | Self-reported number of puffs of e-cigarettes used per day |
Countries
United States
Participant flow
Pre-assignment details
Participants included as having started the study are those who completed the baseline visit
Participants by arm
| Arm | Count |
|---|---|
| Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes | 11 |
| Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes | 7 |
| Usual Cigs; Menthol E-cig Then Tobacco E-cigs Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes | 10 |
| Usual Cigs; Tobacco E-cig Then Menthol E-cigs Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes | 9 |
| Total | 37 |
Baseline characteristics
| Characteristic | Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs | Total | Usual Cigs; Tobacco E-cig Then Menthol E-cigs | Usual Cigs; Menthol E-cig Then Tobacco E-cigs | Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs |
|---|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11 | 47 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 8 | 49 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 37 Participants | 9 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 11 participants | 37 participants | 9 participants | 10 participants | 7 participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 3 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 22 Participants | 6 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 1 / 18 | 1 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 | 0 / 16 | 0 / 15 |
Outcome results
Primary
Number of Cigarettes Smoked Per Day
Number of cigarettes smoked per day as self-reported on tobacco diary
Time frame: 1 month
Population: Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avoid Menthol Cigarettes; Menthol E-cigarettes | Number of Cigarettes Smoked Per Day | 2.2 model estimated cigarettes per day |
| Avoid Menthol Cigarettes; Tobacco E-cigarettes | Number of Cigarettes Smoked Per Day | 1.8 model estimated cigarettes per day |
| Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes | Number of Cigarettes Smoked Per Day | 6.0 model estimated cigarettes per day |
| Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes | Number of Cigarettes Smoked Per Day | 7.1 model estimated cigarettes per day |
Comparison: Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes95% CI: [0.13, 0.72]
Comparison: Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes95% CI: [0.78, 1.22]
Primary
Number of E-cigarette Puffs Used Per Day
Self-reported number of puffs of e-cigarettes used per day
Time frame: 1 month
Population: Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avoid Menthol Cigarettes; Menthol E-cigarettes | Number of E-cigarette Puffs Used Per Day | 61.4 model estimated e-cig puffs per day |
| Avoid Menthol Cigarettes; Tobacco E-cigarettes | Number of E-cigarette Puffs Used Per Day | 57 model estimated e-cig puffs per day |
| Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes | Number of E-cigarette Puffs Used Per Day | 25.5 model estimated e-cig puffs per day |
| Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes | Number of E-cigarette Puffs Used Per Day | 14.9 model estimated e-cig puffs per day |
Comparison: Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes95% CI: [1.39, 6.61]
Comparison: Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes95% CI: [0.59, 0.92]