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Completed

NCT Number: NCT03953508

Perceptions of Cigarette Smoking in Young Adults

This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).

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Key information

Conditions

Smoking, Cigarette Behavior Cigarette Smoking Smoking Tobacco Smoking Tobacco Use

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Experimental cigarette smoking

Primary outcomes

  1. Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale

    Time frame: 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.

  2. Average Daily Subjective Response From Smoking

    Time frame: 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.

  3. Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)

    Time frame: 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.

  4. Past 30-day Cigarette Smoking Frequency

    Time frame: 6-month follow-up survey (6-months post-baseline)

    Number of days smoked cigarettes in the past 30-days

  5. Puff Topography

    Time frame: 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 outcomes

  1. Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task

    Time frame: 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).

  2. Quantity of Past 30-day Tobacco Product Use

    Time frame: 6-month follow-up (6-months post-baseline)

    Number of tobacco products used in the past 30-days

  3. Number of Participants With Intentions to Smoke Menthol Cigarettes

    Time frame: 6-month follow-up (6-months post-baseline)

    Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire

  4. Cigarettes Per Day

    Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)

    Daily report of numbers of cigarettes smoked per day, over 14 days

  5. Average Daily Craving From Smoking

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Menthol and Non-Menthol Cigarette Smoking in Young Adults

Acronym: PRISM

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 16, 2019
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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