Perceptions of Cigarette Smoking in Young Adults

NCT03953508 | Completed Results

• 1 other identifier: PRISM
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking, Cigarette

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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)

• Quantity of Past 30-day Tobacco Product Use

  6-month follow-up (6-months post-baseline)

• Number of Participants With Intentions to Smoke Menthol Cigarettes

  6-month follow-up (6-months post-baseline)

• Cigarettes Per Day

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

• Average Daily Craving From Smoking

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

Study Arms (2)

Menthol

OTHER

Participants who prefer smoking menthol cigarettes

Other: Cigarette flavor type

Non-menthol

OTHER

Participants who prefer smoking non-menthol cigarettes

Other: Cigarette flavor type

Interventions

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.

Also known as: Experimental cigarette smoking

Menthol; Non-menthol

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

• Cohn AM, Elmasry H, Niznik T, Pickworth W, Smith MA, Margaritis WD, Wyatt R, Dunn D, Hedeker D, Murphy J, Audrain-McGovern J, Villanti AC. Racial and ethnic differences in topography and subjective effects among young adults in response to smoking their usual brand menthol or nonmenthol cigarette. Exp Clin Psychopharmacol. 2025 Apr;33(2):145-154. doi: 10.1037/pha0000765. Epub 2025 Feb 24.

  PMID: 39992758 DERIVED

• 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.

  PMID: 35487522 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Limitations and Caveats

Data were collected during the COVID-19 pandemic, during times when there were complete or intermittent shut-downs in-person data collection. This resulted in some changes to the order of administration of the study periods/phases in the protocol.

Results Point of Contact

• Title: Amy Cohn, PhD
• Organization: University of Oklahoma Health Sciences Center

amy-cohn@ouhsc.edu

4052711903

Study Officials

• Amy Cohn, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: August 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)