Smoking, Cigarette
Conditions
Brief summary
This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).
Detailed description
The study will occur in three phases. In session 1 of Phase 1, participants will engage in ad libitum smoking session of one's preferred cigarette brand (menthol or non-menthol). In session 2, participants will take several puffs each of a commercially available menthol and non-menthol cigarette (i.e., Camel Crush) and complete a complete a series of pre-post smoking questionnaires, and in Session 3 participants will complete a computerized task to measure perceptions of cigarette smoking. For the computerized task, participants will be able to win points toward earning puffs of a cigarette and will be able to smoke puffs earned. Participants will be asked to abstain from smoking for at least 12 hours before each in-person visit. Phase 2 participants will engage in 14 days of surveys they will complete on their cell to measure different aspects of smoking behavior. These surveys will happen twice a day at random times. For phase 3, participants will complete an assessment of smoking behavior and related factors 6-months after the baseline assessment either in-person, in the laboratory, or via telephone or online (if in-person follow-up is not viable). The order in which phases occur differed was a result of COVID-19 restrictions on data collection. For some participants, they started EMA first and then began laboratory data collection when in-person was allowed. For others, they started laboratory data collection when COVID restrictions were lifted. Thus, the participant flow may appear unbalanced.
Interventions
OTHERCigarette flavor type
Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18-26 * Currently smoke cigarettes everyday or somedays * A strong preference for menthol or non-menthol cigarettes * able to read and understand the consent form * willingness to abstain from nicotine or tobacco products for at least 12 hours prior to smoking sessions
Exclusion criteria
* Current use of nicotine replacement therapy * Pregnant or planning to become pregnant; or breastfeeding * self-reported diagnosis of lung disease, including asthma, cystic fibrosis, or chronic obstructive pulmonary disease; or * self-reported history of cardiac event or distress within the past 3-months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Puff Topography | Laboratory session 1 (up to 4 weeks after baseline) | Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1. |
| Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale | immediately after smoking usual brand cigarette, at baseline | ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7. |
| Average Daily Subjective Response From Smoking | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) | average daily scores of subjective reward from smoking from daily diary surveys, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. Averaged across 14 days. |
| Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes) | Lab session 3 (estimated average 1-4 weeks after baseline) | Participants completed a choice task assessing willingness to work to click targets on a computer screen to earn menthol or non-menthol cigarette puffs. The relative reinforcing value for menthol was defined by the Breakpoint, or the highest trial (out of 10 trials) completed for a menthol cigarette puff. |
| Past 30-day Cigarette Smoking Frequency | 6-month follow-up survey (6-months post-baseline) | Number of days smoked cigarettes in the past 30-days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task | immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline) | This outcome represents the total number of clicks (over 10 trials) for the menthol cigarette puff on the behavioral choice task. The reinforcement schedule to click/earn a menthol cigarette puff increased progressively by 25 clicks at each trial such that 25, 50, 75, 100, 125, 150, 175, 200, 225, and 250 clicks of the menthol cigarette image on a computer screen had to be achieved to earn a menthol puff at each trial (maximum possible of 1375 clicks over the task for menthol puffs). All puffs were taken once the entire task was completed (after all 10 trials were done). |
| Quantity of Past 30-day Tobacco Product Use | 6-month follow-up (6-months post-baseline) | Number of tobacco products used in the past 30-days |
| Number of Participants With Intentions to Smoke Menthol Cigarettes | 6-month follow-up (6-months post-baseline) | Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire |
| Cigarettes Per Day | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) | Daily report of numbers of cigarettes smoked per day, over 14 days |
| Average Daily Craving From Smoking | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) | Average daily cigarette craving, aggregated over 14 days, from a 1-item questionnaire measure that was administered daily. Scores range from 0 = not at all to 4 = extremely, where higher scores indicate greater craving intensity. |
Countries
United States
Participant flow
Pre-assignment details
The order in which phases occurred differed as a result of COVID-19 restrictions on in-person data collection. Some participants started EMA first and then began laboratory data collection when in-person data collection was allowed. Other participants started laboratory data collection first (when COVID restrictions were lifted), and then did EMA after laboratory data collection. Thus, the participant flow may appear unbalanced.
Participants by arm
| Arm | Count |
|---|---|
| Menthol Status Those who prefer menthol cigarettes | 60 |
| Non-menthol Status Those who prefer non-menthol | 61 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6-month Follow-up | Lost to Follow-up | 62 | 70 |
| Baseline | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Non-menthol Status | Total | Menthol Status |
|---|---|---|---|
| Age, Continuous | 24.2 years STANDARD_DEVIATION 2 | 23.9 years STANDARD_DEVIATION 2.1 | 23.6 years STANDARD_DEVIATION 2.2 |
| Cigarettes smoked per day | 11.8 cigarettes smoked per day STANDARD_DEVIATION 7.4 | 10 cigarettes smoked per day STANDARD_DEVIATION 6.7 | 8.1 cigarettes smoked per day STANDARD_DEVIATION 5.4 |
| Highest level of education High school education or less | 35 Participants | 59 Participants | 24 Participants |
| Highest level of education Some college education or more | 26 Participants | 62 Participants | 36 Participants |
| Past 30-day cigarette smoking frequency | 26.5 Number of days smoked cigarettes STANDARD_DEVIATION 7.9 | 25.2 Number of days smoked cigarettes STANDARD_DEVIATION 8.4 | 24.0 Number of days smoked cigarettes STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Non-White | 22 Participants | 45 Participants | 23 Participants |
| Race/Ethnicity, Customized White | 39 Participants | 76 Participants | 37 Participants |
| Region of Enrollment United States | 61 Participants | 121 Participants | 60 Participants |
| Sex: Female, Male Female | 33 Participants | 69 Participants | 36 Participants |
| Sex: Female, Male Male | 28 Participants | 52 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 61 |
| other Total, other adverse events | 0 / 60 | 1 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 61 |
Outcome results
Primary
Average Daily Subjective Response From Smoking
average daily scores of subjective reward from smoking from daily diary surveys, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. Averaged across 14 days.
Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
Population: Young adult menthol and non-menthol smokers who reported on their daily cigarette smoking during 14-days of ecological momentary assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Average Daily Subjective Response From Smoking | 1.68 average daily scores | Standard Deviation 0.98 |
| Non-menthol | Average Daily Subjective Response From Smoking | 1.79 average daily scores | Standard Deviation 0.86 |
p-value: >0.05t-test, 2 sided
Primary
Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)
Participants completed a choice task assessing willingness to work to click targets on a computer screen to earn menthol or non-menthol cigarette puffs. The relative reinforcing value for menthol was defined by the Breakpoint, or the highest trial (out of 10 trials) completed for a menthol cigarette puff.
Time frame: Lab session 3 (estimated average 1-4 weeks after baseline)
Population: young adult cigarette smokers ages 18-26 who completed the third of three laboratory sessions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes) | 9.2 highest trial competed for menthol puffs | Standard Deviation 2.05 |
| Non-menthol | Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes) | 0.83 highest trial competed for menthol puffs | Standard Deviation 2.47 |
p-value: <0.05ANOVA
Primary
Past 30-day Cigarette Smoking Frequency
Number of days smoked cigarettes in the past 30-days
Time frame: 6-month follow-up survey (6-months post-baseline)
Population: Young adult smokers ages 18-26 who completed the 6-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Past 30-day Cigarette Smoking Frequency | 20.8 days | Standard Deviation 11.9 |
| Non-menthol | Past 30-day Cigarette Smoking Frequency | 20.7 days | Standard Deviation 11.4 |
p-value: <0.05t-test, 2 sided
Primary
Puff Topography
Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1.
Time frame: Laboratory session 1 (up to 4 weeks after baseline)
Population: young adult cigarette smokers ages 18-26 who completed the baseline/visit 1 and provided valid puff topography data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Puff Topography | 18.7 number of cigarette puffs | Standard Deviation 6.1 |
| Non-menthol | Puff Topography | 18.4 number of cigarette puffs | Standard Deviation 7.3 |
p-value: >0.05ANOVA
Primary
Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale
ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7.
Time frame: immediately after smoking usual brand cigarette, at baseline
Population: Young adult menthol and non-menthol smokers, ages 18-26 who completed the baseline/first study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale | 4.68 score on a scale | Standard Error 0.16 |
| Non-menthol | Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale | 4.50 score on a scale | Standard Error 0.16 |
p-value: >0.05ANCOVA
Secondary
Average Daily Craving From Smoking
Average daily cigarette craving, aggregated over 14 days, from a 1-item questionnaire measure that was administered daily. Scores range from 0 = not at all to 4 = extremely, where higher scores indicate greater craving intensity.
Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Average Daily Craving From Smoking | 1.55 average daily scores | Standard Deviation 0.75 |
| Non-menthol | Average Daily Craving From Smoking | 1.53 average daily scores | Standard Deviation 0.75 |
p-value: >0.05t-test, 2 sided
Secondary
Cigarettes Per Day
Daily report of numbers of cigarettes smoked per day, over 14 days
Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Cigarettes Per Day | 9.9 cigarettes per day | Standard Deviation 7.6 |
| Non-menthol | Cigarettes Per Day | 9.5 cigarettes per day | Standard Deviation 7.6 |
p-value: >0.05t-test, 2 sided
Secondary
Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task
This outcome represents the total number of clicks (over 10 trials) for the menthol cigarette puff on the behavioral choice task. The reinforcement schedule to click/earn a menthol cigarette puff increased progressively by 25 clicks at each trial such that 25, 50, 75, 100, 125, 150, 175, 200, 225, and 250 clicks of the menthol cigarette image on a computer screen had to be achieved to earn a menthol puff at each trial (maximum possible of 1375 clicks over the task for menthol puffs). All puffs were taken once the entire task was completed (after all 10 trials were done).
Time frame: immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline)
Population: Young adult cigarette smokers (ages 18-26) who completed session 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task | 1244.56 number of clicks for menthol puffs | Standard Deviation 326.49 |
| Non-menthol | Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task | 104.11 number of clicks for menthol puffs | Standard Deviation 334.44 |
p-value: <0.05ANOVA
Secondary
Number of Participants With Intentions to Smoke Menthol Cigarettes
Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire
Time frame: 6-month follow-up (6-months post-baseline)
Population: Young adult cigarette smokers ages 18-26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menthol | Number of Participants With Intentions to Smoke Menthol Cigarettes | 16 Participants |
p-value: >0.05Fisher Exact
Secondary
Quantity of Past 30-day Tobacco Product Use
Number of tobacco products used in the past 30-days
Time frame: 6-month follow-up (6-months post-baseline)
Population: Young adult smokers ages 18-26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menthol | Quantity of Past 30-day Tobacco Product Use | 1.3 tobacco products | Standard Deviation 1 |
| Non-menthol | Quantity of Past 30-day Tobacco Product Use | 2 tobacco products | Standard Deviation 0.9 |
p-value: <0.05t-test, 2 sided