Perceptions of Cigarette Smoking in Young Adults

Study Overview
=================
Brief Summary
-----------------
This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 24) who started smoking in the past 6-months.

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 may differ was a result of COVID-19 restrictions on data collection.

Official Title
-----------------
Menthol and Non-Menthol Cigarette Smoking in Young Adults

Conditions
-----------------
Smoking, Cigarette

Intervention / Treatment
-----------------
* Other: Cigarette flavor type


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Menthol<br>Participants will smoke and rate several puffs of a menthol Camel Crush cigarette | Other: Cigarette flavor type<br>* Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.<br>|
| Other: Non-menthol<br>Participants will smoke and rate several puffs of a non-menthol Camel Crush cigarette | Other: Cigarette flavor type<br>* Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective response to smoking cigarettes from the Cigarette Evaluation Scale | ratings of subjective response from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. | immediately after smoking usual brand cigarette, at baseline | 
| Within-day subjective response from smoking | within-day ratings of subjective reward from smoking from daily diary surveys | Phase 2 daily diary surveys (estimated average 2-4 weeks after baseline) | 
| Between-day subjective response to smoking | day-to-day changes in ratings of subjective response to smoking | Phase 2 daily diary surveys (estimated average 2-4 weeks after baseline) | 
| Relative reinforcing value of menthol versus non-menthol cigarettes | Breakpoint, or highest trial completed for menthol cigarette puffs on the behavioral | immediately after completing the behavioral economic choice task, lab session 3 of Phase 1 (estimated average 1-4 weeks).. | 
| 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) | 
| Nicotine dependence | Self-report rating of nicotine dependence severity from the Fagerstrom Test of Nicotine Dependence | 6-month follow-up survey (6-months post-baseline) | 
| Past 30-day cigarette smoking quantity | Number of cigarettes smoked per day in the past 30-days | 6-month follow-up survey (6-months post-baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puff Topography | Total inhalation volume | Through Phase 1 completion, estimated up to 4 weeks post-baseline | 
| Number of choice task clicks for menthol versus non-menthol cigarettes | Total number of responses for the menthol versus the non-menthol-cigarettes | immediately after completing the behavioral economic choice task, lab session 3 of Phase 1 (estimated average 1-4 weeks).. | 
| 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) | 
| Quantity of flavored past 30-day tobacco product use | Number of flavored tobacco products use in the past 30-days | 6-month follow-up (6-months post-baseline) | 
| Frequency of past 30-day tobacco product use | Number of days used any tobacco products in the past 30-days | 6-month follow-up (6-months post-baseline) | 
| Frequency of flavored past 30-day tobacco product use | Number of days used any flavored tobacco products in the past 30-days | 6-month follow-up (6-months post-baseline) | 
| Intentions to smoke menthol cigarettes | Self-reported intentions to smoke menthol cigarettes assessed via a questionnaire | 6-month follow-up (6-months post-baseline) | 
| Daily ratings of subjective response to smoking | Daily ratings of subjective response to smoking, over 14 days, from the Modified Cigarette Evaluation Questionnaire | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) | 
| Day-to-day change in subjective response to smoking | Changes in daily ratings of subjective response response to smoking, over 14 days, from the Modified Cigarette Evaluation Questionnaire | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) | 
| Day-to-day variability in subjective response to smoking | Examining the standard deviation of daily ratings of subjective response to smoking, over 14 days, from the Modified Cigarette Evaluation Questionnaire | Phase 2 daily diary surveys (estimated 2-4 weeks after 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) | 
| Daily ratings of craving intensity | Daily self-report of craving intensity, from a 1-item questionnaire measure | Phase 2 daily diary surveys (estimated 2-4 weeks after baseline) |