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 26).

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 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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

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

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 who prefer smoking menthol cigarettes	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 Names: Experimental cigarette smoking
Other: Non-menthol; Participants who prefer smoking non-menthol cigarettes	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 Names: Experimental cigarette smoking

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 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.	immediately after smoking usual brand cigarette, at baseline
Average Daily Subjective Response From Smoking	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.	Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)	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.	Lab session 3 (estimated average 1-4 weeks after baseline)
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)
Puff Topography	Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1.	Laboratory session 1 (up to 4 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task	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).	immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline)
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)
Number of Participants With Intentions to Smoke Menthol Cigarettes	Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire	6-month follow-up (6-months post-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)
Average Daily Craving From Smoking	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.	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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

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