Clinical trial NCT03953508: Perceptions of Cigarette Smoking in Young Adults
Official title: Menthol and Non-Menthol Cigarette Smoking in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale
timeFrame: immediately after smoking usual brand cigarette, at baseline
measure: Average Daily Subjective Response From Smoking
timeFrame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
measure: Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)
timeFrame: Lab session 3 (estimated average 1-4 weeks after baseline)
measure: Past 30-day Cigarette Smoking Frequency
timeFrame: 6-month follow-up survey (6-months post-baseline)
measure: Puff Topography
timeFrame: Laboratory session 1 (up to 4 weeks after baseline)
Secondary outcomes:
measure: Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task
timeFrame: immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline)
measure: Quantity of Past 30-day Tobacco Product Use
timeFrame: 6-month follow-up (6-months post-baseline)
measure: Number of Participants With Intentions to Smoke Menthol Cigarettes
timeFrame: 6-month follow-up (6-months post-baseline)
measure: Cigarettes Per Day
timeFrame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
measure: Average Daily Craving From Smoking
timeFrame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Health Promotion Research Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Amy Cohn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.