Perceptions of Cigarette Smoking in Young Adults

Not Applicable

Completed

Conditions: Smoking, Cigarette

Interventions: Other: Cigarette flavor type

Registration Number: NCT03953508

Lead Sponsor: University of Oklahoma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 199

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-menthol	Cigarette flavor type	Participants will smoke and rate several puffs of a non-menthol Camel Crush cigarette
Menthol	Cigarette flavor type	Participants will smoke and rate several puffs of a menthol Camel Crush cigarette

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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.