Perceptions of Cigarette Smoking in Young Adults

Smoking, Cigarette Clinical Trial

— PRISM  

Official title:

Menthol and Non-Menthol Cigarette Smoking in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953508
• Other study ID #: PRISM
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking, Cigarette

Intervention

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.

Locations

Country	Name	City	State
United States	Health Promotion Research Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)..
Primary	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)
Primary	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)
Primary	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	Puff Topography	Total inhalation volume	Through Phase 1 completion, estimated up to 4 weeks post-baseline
Secondary	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)..
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Intentions to smoke menthol cigarettes	Self-reported intentions to smoke menthol cigarettes assessed via a questionnaire	6-month follow-up (6-months post-baseline)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)