PRISM: Perceptions of Cigarette Smoking in Young Adults

Sponsor
University of Oklahoma (Other)
Overall Status
Recruiting
CT.gov ID
NCT03953508
Collaborator
(none)
250
1
2
30
8.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cigarette flavor type
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Menthol and Non-Menthol Cigarette Smoking in Young Adults
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Subjective response to smoking cigarettes from the Cigarette Evaluation Scale [immediately after smoking usual brand cigarette, at baseline]

    ratings of subjective response from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response.

  2. Within-day subjective response from smoking [Phase 2 daily diary surveys (estimated average 2-4 weeks after baseline)]

    within-day ratings of subjective reward from smoking from daily diary surveys

  3. Between-day subjective response to smoking [Phase 2 daily diary surveys (estimated average 2-4 weeks after baseline)]

    day-to-day changes in ratings of subjective response to smoking

  4. Relative reinforcing value of menthol versus non-menthol cigarettes [immediately after completing the behavioral economic choice task, lab session 3 of Phase 1 (estimated average 1-4 weeks)..]

    Breakpoint, or highest trial completed for menthol cigarette puffs on the behavioral

  5. Past 30-day cigarette smoking frequency [6-month follow-up survey (6-months post-baseline)]

    Number of days smoked cigarettes in the past 30-days

  6. Nicotine dependence [6-month follow-up survey (6-months post-baseline)]

    Self-report rating of nicotine dependence severity from the Fagerstrom Test of Nicotine Dependence

  7. Past 30-day cigarette smoking quantity [6-month follow-up survey (6-months post-baseline)]

    Number of cigarettes smoked per day in the past 30-days

Secondary Outcome Measures

  1. Puff Topography [Through Phase 1 completion, estimated up to 4 weeks post-baseline]

    Total inhalation volume

  2. Number of choice task clicks for menthol versus non-menthol cigarettes [immediately after completing the behavioral economic choice task, lab session 3 of Phase 1 (estimated average 1-4 weeks)..]

    Total number of responses for the menthol versus the non-menthol-cigarettes

  3. Quantity of past 30-day tobacco product use [6-month follow-up (6-months post-baseline)]

    Number of tobacco products used in the past 30-days

  4. Quantity of flavored past 30-day tobacco product use [6-month follow-up (6-months post-baseline)]

    Number of flavored tobacco products use in the past 30-days

  5. Frequency of past 30-day tobacco product use [6-month follow-up (6-months post-baseline)]

    Number of days used any tobacco products in the past 30-days

  6. Frequency of flavored past 30-day tobacco product use [6-month follow-up (6-months post-baseline)]

    Number of days used any flavored tobacco products in the past 30-days

  7. Intentions to smoke menthol cigarettes [6-month follow-up (6-months post-baseline)]

    Self-reported intentions to smoke menthol cigarettes assessed via a questionnaire

  8. Daily ratings of subjective response to smoking [Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)]

    Daily ratings of subjective response to smoking, over 14 days, from the Modified Cigarette Evaluation Questionnaire

  9. Day-to-day change in subjective response to smoking [Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)]

    Changes in daily ratings of subjective response response to smoking, over 14 days, from the Modified Cigarette Evaluation Questionnaire

  10. Day-to-day variability in subjective response to smoking [Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)]

    Examining the standard deviation of daily ratings of subjective response to smoking, over 14 days, from the Modified Cigarette Evaluation Questionnaire

  11. Cigarettes per day [Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)]

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

  12. Daily ratings of craving intensity [Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)]

    Daily self-report of craving intensity, from a 1-item questionnaire measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Health Promotion Research Center Oklahoma City Oklahoma United States 73104

Sponsors and Collaborators

  • University of Oklahoma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT03953508
Other Study ID Numbers:
  • PRISM
First Posted:
May 16, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 12, 2022