Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
199 participants
INTERVENTIONAL
2020-08-01
2023-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Menthol
Participants who prefer smoking menthol cigarettes
Cigarette flavor type
Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.
Non-menthol
Participants who prefer smoking non-menthol cigarettes
Cigarette flavor type
Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
26 Years
ALL
Yes
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Amy Cohn, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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Health Promotion Research Center
Oklahoma City, Oklahoma, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRISM
Identifier Type: -
Identifier Source: org_study_id