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Perceptions of Cigarette Smoking in Young Adults (PRISM)

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ClinicalTrials.gov Identifier: NCT03953508
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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
Smoking, Cigarette Other: Cigarette flavor type Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
Drug Information available for: Menthol

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Puff Topography [ Time Frame: Phase 1: During cigarette smoking ]
    Total inhalation volume

  2. Subjective satisfaction from smoking [ Time Frame: immediately after cigarette smoking ]
    ratings of satisfaction from smoking

  3. Subjective reward from smoking [ Time Frame: immediately after cigarette smoking ]
    ratings of reward from smoking

  4. Subjective throat hit from smoking [ Time Frame: immediately after cigarette smoking ]
    ratings of perceptions on the throat and tongue from smoking



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18-24
  • Started regular smoking in the past 6-months
  • Currently smoke cigarettes "everyday" or "somedays"
  • A strong preference for menthol or non-menthol cigarettes

Exclusion Criteria:

  • Current use of nicotine replacement therapy
  • Pregnant or planning to become pregnant; or at risk of becoming pregnant
  • Past or current self-report clinically significant heart disease or hypertension, or other smoking-related disease (by history) that would preclude successful study completion
  • Previous or current use of the experimental cigarette (Camel Crush)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953508


Contacts
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Contact: Research Project Coordinator 405-271-7759 PRISMStudy@ouhsc.edu

Locations
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United States, Oklahoma
Oklahoma Tobacco Research Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Research Project Coordinator    405-271-7759    prismStudy@ouhsc.edu   
Principal Investigator: Amy Cohn, PhD         
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Amy Cohn, PhD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03953508     History of Changes
Other Study ID Numbers: 10581 PRISM
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents