Perceptions of Cigarette Smoking in Young Adults (PRISM)

Menthol and Non-Menthol 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 24) who started smoking in the past 6-months.

Study Overview

• Status: Completed
• Conditions: Smoking, Cigarette
• Intervention / Treatment: Other: Cigarette flavor type

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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Project Coordinator; Phone Number: 405-271-7759; Email: prismStudy@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Health Promotion Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Amy Cohn, PhD, University of Oklahoma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PRISM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No