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Completed

NCT Number: NCT05849051

Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs

The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.

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Key information

Conditions

Tobacco Use Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study.

At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol.

For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions.

On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts.

For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Members of the recruitment panel (the investigators are partnering with a panel provider for recruitment of all participants)
  • Agree to provide their honest answers
  • Current little cigar and/or cigarillo every day or some day users
  • Over 21 years old
  • Currently living in US
  • Feel comfortable taking a survey in English without help
  • Feel comfortable taking an online survey without help
  • Have an email address that they check regularly
  • Have access to the internet at work or home
  • Able to read and respond to surveys delivered to their email
  • Able to complete 2 surveys that take approximately 20 minutes
  • Able to complete a 5 minute survey each day for 20 days
  • Able to verify they are not a bot using CAPTCHA
  • Able to answer a simple, random math question

Exclusion criteria

  • None

Treatment and study plan

Newly developed warnings with images at 30% size

Behavioral

On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.

FDA proposed text-only warnings at 30% size

Behavioral

On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.

Primary outcomes

  1. LCC Quit Intentions

    Time frame: day 21 (post test)

    Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.

Secondary outcomes

  1. Number of LCCs Smoked in Past Day

    Time frame: day 1

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.

  2. Number of LCCs Smoked in Past Day

    Time frame: day 2

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  3. Number of LCCs Smoked in Past Day

    Time frame: day 3

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants.

  4. Number of LCCs Smoked in Past Day

    Time frame: day 4

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.

  5. Number of LCCs Smoked in Past Day

    Time frame: day 5

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  6. Number of LCCs Smoked in Past Day

    Time frame: day 6

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  7. Number of LCCs Smoked in Past Day

    Time frame: day 7

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  8. Number of LCCs Smoked in Past Day

    Time frame: day 8

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  9. Number of LCCs Smoked in Past Day

    Time frame: day 9

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  10. Number of LCCs Smoked in Past Day

    Time frame: day 10

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  11. Number of LCCs Smoked in Past Day

    Time frame: day 11

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  12. Number of LCCs Smoked in Past Day

    Time frame: day 12

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  13. Number of LCCs Smoked in Past Day

    Time frame: day 13

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  14. Number of LCCs Smoked in Past Day

    Time frame: day 14

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  15. Number of LCCs Smoked in Past Day

    Time frame: day 15

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  16. Number of LCCs Smoked in Past Day

    Time frame: day 16

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  17. Number of LCCs Smoked in Past Day

    Time frame: day 17

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  18. Number of LCCs Smoked in Past Day

    Time frame: day 18

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  19. Number of LCCs Smoked in Past Day

    Time frame: day 19

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  20. Number of LCCs Smoked in Past Day

    Time frame: day 20

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  21. Number of LCCs Smoked in Past Day

    Time frame: day 21 (post test)

    The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant

  22. Number of Days Smoked LCCs in Past Week

    Time frame: day 7

    The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week

  23. Number of Days Smoked LCCs in Past Week

    Time frame: day 14

    The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week

  24. Number of Days Smoked LCCs in Past Week

    Time frame: day 21 (post test)

    The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week

  25. Number of LCCs Smoked in the Past Week

    Time frame: day 7

    The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant

  26. Number of LCCs Smoked in the Past Week

    Time frame: day 14

    The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant

  27. Number of LCCs Smoked in the Past Week

    Time frame: day 21 (post test)

    The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant

  28. Number of LCCs Butted Out in the Past Week

    Time frame: day 7

    The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week

  29. Number of LCCs Butted Out in the Past Week

    Time frame: day 14

    The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week

  30. Number of LCCs Butted Out in the Past Week

    Time frame: day 21 (post test)

    The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week

  31. Number of LCCs Forgone in the Past Week

    Time frame: day 7

    The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week

  32. Number of LCCs Forgone in the Past Week

    Time frame: day 14

    The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week

  33. Number of LCCs Forgone in the Past Week

    Time frame: day 21 (post test)

    The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week

  34. LCC Quit Attempts in Past Week

    Time frame: day 7

    The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week

  35. LCC Quit Attempts in Past Week

    Time frame: day 14

    The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week

  36. LCC Quit Attempts in Past Week

    Time frame: day 21 (post test)

    The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week

  37. LCC Quit Intentions

    Time frame: day 7

    Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.

  38. LCC Quit Intentions

    Time frame: day 14

    Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.

  39. Self Reported Learning

    Time frame: day 21 (post test)

    Mean self-reported learning reported by participants. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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