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This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol | Other | Participants who prefer smoking menthol cigarettes |
|
| Non-menthol | Other | Participants who prefer smoking non-menthol cigarettes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette flavor type | Other | Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after smoking usual brand cigarette, at baseline |
| 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. | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |
| 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. | Lab session 3 (estimated average 1-4 weeks after baseline) |
| Past 30-day Cigarette Smoking Frequency | Number of days smoked cigarettes in the past 30-days | 6-month follow-up survey (6-months post-baseline) |
| Puff Topography | Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1. | Laboratory session 1 (up to 4 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Cohn, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Promotion Research Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39992758 | Derived | Cohn AM, Elmasry H, Niznik T, Pickworth W, Smith MA, Margaritis WD, Wyatt R, Dunn D, Hedeker D, Murphy J, Audrain-McGovern J, Villanti AC. Racial and ethnic differences in topography and subjective effects among young adults in response to smoking their usual brand menthol or nonmenthol cigarette. Exp Clin Psychopharmacol. 2025 Apr;33(2):145-154. doi: 10.1037/pha0000765. Epub 2025 Feb 24. | |
| 35487522 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol Status | Those who prefer menthol cigarettes |
| FG001 | Non-menthol Status | Those who prefer non-menthol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Ecological Momentary Assessment |
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| Laboratory Period |
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| 6-month Follow-up |
|
Number of participants who completed the baseline survey and attended the first study session to smoke their usual brand cigarette. Some participants completed the baseline survey remotely, due to COVID, and then came to the laboratory to complete the first study visit. Not everyone who completed the baseline survey remotely showed up for the first study visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Menthol Status | Those who prefer menthol cigarettes |
| BG001 | Non-menthol Status | Those who prefer non-menthol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Young adult menthol and non-menthol smokers, ages 18-26 who completed the baseline/first study visit | Posted | Mean | Standard Error | score on a scale | immediately after smoking usual brand cigarette, at baseline |
|
Adverse events data were collected for the entirety of study participation; approximately 6 months.
One participant vomited after smoking a cigarette in the study lab, after smoking a non-menthol Camel Crush cigarette. The participant was instructed to smoke 3 to 5 puffs In a subsequent follow-up (approximately a week later), the participant was feeling fine and wanted to schedule their next session. The participant indicated that they thought they had food poisoning. The adverse event was reported to the IRB and was not considered due to enrollment in the study or the study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Menthol Status | Those who prefer menthol cigarettes | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Gastrointestinal disorders | Other | Non-systematic Assessment | Participant vomited after smoking a study cigarette in the laboratory. |
Data were collected during the COVID-19 pandemic, during times when there were complete or intermittent shut-downs in-person data collection. This resulted in some changes to the order of administration of the study periods/phases in the protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Cohn, PhD | University of Oklahoma Health Sciences Center | 4052711903 | amy-cohn@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2022 | Oct 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline) |
| Quantity of Past 30-day Tobacco Product Use | Number of tobacco products used in the past 30-days | 6-month follow-up (6-months post-baseline) |
| Number of Participants With Intentions to Smoke Menthol Cigarettes | Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire | 6-month follow-up (6-months post-baseline) |
| Cigarettes Per Day | Daily report of numbers of cigarettes smoked per day, over 14 days | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |
| 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. | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |
| Derived |
| Cohn AM, Pickworth W, Audrain-McGovern J, Murphy J, Villanti AC, Hedeker D, Dunn D, Wyatt R, Niznik T, Cotten W, Smith M, Ehlke SJ. Measuring young adult appeal for menthol and non-menthol cigarettes: protocol of a clinical trial using both laboratory and intensive longitudinal methods (PRISM). BMJ Open. 2022 Apr 28;12(4):e058823. doi: 10.1136/bmjopen-2021-058823. |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Highest level of education | Count of Participants | Participants |
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| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes smoked per day |
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| Past 30-day cigarette smoking frequency | Mean | Standard Deviation | Number of days smoked cigarettes |
|
|
|
|
| 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. | Young adult menthol and non-menthol smokers who reported on their daily cigarette smoking during 14-days of ecological momentary assessment | Posted | Mean | Standard Deviation | average daily scores | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |
|
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|
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| 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. | young adult cigarette smokers ages 18-26 who completed the third of three laboratory sessions | Posted | Mean | Standard Deviation | highest trial competed for menthol puffs | Lab session 3 (estimated average 1-4 weeks after baseline) |
|
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| Primary | Past 30-day Cigarette Smoking Frequency | Number of days smoked cigarettes in the past 30-days | Young adult smokers ages 18-26 who completed the 6-month follow-up survey | Posted | Mean | Standard Deviation | days | 6-month follow-up survey (6-months post-baseline) |
|
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|
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| Primary | Puff Topography | Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1. | young adult cigarette smokers ages 18-26 who completed the baseline/visit 1 and provided valid puff topography data | Posted | Mean | Standard Deviation | number of cigarette puffs | Laboratory session 1 (up to 4 weeks after baseline) |
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| 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). | Young adult cigarette smokers (ages 18-26) who completed session 3 | Posted | Mean | Standard Deviation | number of clicks for menthol puffs | immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline) |
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| Secondary | Quantity of Past 30-day Tobacco Product Use | Number of tobacco products used in the past 30-days | Young adult smokers ages 18-26 | Posted | Mean | Standard Deviation | tobacco products | 6-month follow-up (6-months post-baseline) |
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| 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 | Young adult cigarette smokers ages 18-26 | Posted | Count of Participants | Participants | 6-month follow-up (6-months post-baseline) |
|
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| Secondary | Cigarettes Per Day | Daily report of numbers of cigarettes smoked per day, over 14 days | Posted | Mean | Standard Deviation | cigarettes per day | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |
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| 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. | Posted | Mean | Standard Deviation | average daily scores | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |
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|
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Non-menthol Status | Those who prefer non-menthol | 0 | 61 | 0 | 61 | 1 | 61 |
|
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