Tobacco Use Disorder
Conditions
Brief summary
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive credits that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.
Interventions
OTHERMenthol ban on cigarettes
Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
OTHERMenthol ban on cigarettes and e-cigarettes
Participants will have neither menthol flavored cigarettes or e-cigarettes available
OTHERNo menthol ban
Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
Sponsors
National Institute on Drug Abuse (NIDA)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between the ages of 18 and 64 * Purchase exclusively menthol cigarettes * Not currently motivated to quit smoking * Smoking a minimum number of cigarettes per day
Exclusion criteria
* Report a serious, unstable medical or psychiatric condition * Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking) * Have used any smoking cessation therapy during the past month * Regularly use any form of tobacco other than cigarettes * Are pregnant or breast feeding or planning to become pregnant or breast feed during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Tobacco Product Used | 6 weeks | Total number of cigarettes smoked and puffs of e-cigarettes used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| How Much of Each Product is Obtained From the Experimental Marketplace | 6 weeks | Number of packs of cigarettes obtained and amount of e-liquid obtained from the experimental marketplace |
| Motivation to Quit Smoking Cigarettes | 6 weeks | Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Menthol Ban Only for Cigarettes Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes | 16 |
| Menthol Ban for Cigarettes and E-cigarettes Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available | 15 |
| No Menthol Ban Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available | 16 |
| Total | 47 |
Baseline characteristics
| Characteristic | Total | Menthol Ban Only for Cigarettes | Menthol Ban for Cigarettes and E-cigarettes | No Menthol Ban |
|---|---|---|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 10.3 | 45.8 years STANDARD_DEVIATION 9.8 | 44.9 years STANDARD_DEVIATION 11.2 | 44.1 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 16 Participants | 14 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 7 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 7 Participants | 10 Participants | 9 Participants |
| Region of Enrollment United States | 47 participants | 16 participants | 15 participants | 16 participants |
| Sex: Female, Male Female | 25 Participants | 8 Participants | 8 Participants | 9 Participants |
| Sex: Female, Male Male | 22 Participants | 8 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 2 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 16 |
Outcome results
Primary
Amount of Tobacco Product Used
Total number of cigarettes smoked and puffs of e-cigarettes used
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Menthol Ban Only for Cigarettes | Amount of Tobacco Product Used | Cigarettes smoked per day | 13.1 tobacco products use per day | Standard Deviation 5.5 |
| Menthol Ban Only for Cigarettes | Amount of Tobacco Product Used | Puffs of e-cigarettes used per day | 56.7 tobacco products use per day | Standard Deviation 180.2 |
| Menthol Ban for Cigarettes and E-cigarettes | Amount of Tobacco Product Used | Cigarettes smoked per day | 18.6 tobacco products use per day | Standard Deviation 5.7 |
| Menthol Ban for Cigarettes and E-cigarettes | Amount of Tobacco Product Used | Puffs of e-cigarettes used per day | 10.7 tobacco products use per day | Standard Deviation 24.9 |
| No Menthol Ban | Amount of Tobacco Product Used | Cigarettes smoked per day | 15.3 tobacco products use per day | Standard Deviation 5 |
| No Menthol Ban | Amount of Tobacco Product Used | Puffs of e-cigarettes used per day | 4.5 tobacco products use per day | Standard Deviation 8.6 |
95% CI: [1.1, 1.75]
95% CI: [0.68, 1.11]
95% CI: [0.99, 1.45]
Comparison: Average number of puffs per participants over the 6 week study periodp-value: 0.349Kruskal-Wallis
Secondary
How Much of Each Product is Obtained From the Experimental Marketplace
Number of packs of cigarettes obtained and amount of e-liquid obtained from the experimental marketplace
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Menthol Ban Only for Cigarettes | How Much of Each Product is Obtained From the Experimental Marketplace | Packs of cigarettes | 22.6 units of tobacco | Standard Deviation 10.38 |
| Menthol Ban Only for Cigarettes | How Much of Each Product is Obtained From the Experimental Marketplace | Units of e-cigarette liquid | 3.13 units of tobacco | Standard Deviation 3.16 |
| Menthol Ban for Cigarettes and E-cigarettes | How Much of Each Product is Obtained From the Experimental Marketplace | Packs of cigarettes | 29.3 units of tobacco | Standard Deviation 11.06 |
| Menthol Ban for Cigarettes and E-cigarettes | How Much of Each Product is Obtained From the Experimental Marketplace | Units of e-cigarette liquid | 1.2 units of tobacco | Standard Deviation 1.57 |
| No Menthol Ban | How Much of Each Product is Obtained From the Experimental Marketplace | Packs of cigarettes | 28.8 units of tobacco | Standard Deviation 10.7 |
| No Menthol Ban | How Much of Each Product is Obtained From the Experimental Marketplace | Units of e-cigarette liquid | 1.06 units of tobacco | Standard Deviation 1.34 |
Comparison: Comparison among groups in number of cigarette packs selectedp-value: 0.185Mixed Models Analysis
Comparison: Comparison among groups in number of e-cigarette liquid units selectedp-value: 0.076Mixed Models Analysis
Secondary
Motivation to Quit Smoking Cigarettes
Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol Ban Only for Cigarettes | Motivation to Quit Smoking Cigarettes | 3.6 units on a scale | Standard Deviation 2.2 |
| Menthol Ban for Cigarettes and E-cigarettes | Motivation to Quit Smoking Cigarettes | 3.1 units on a scale | Standard Deviation 2.2 |
| No Menthol Ban | Motivation to Quit Smoking Cigarettes | 3.2 units on a scale | Standard Deviation 1.7 |
p-value: 0.27Mixed Models Analysis