Clinical trial NCT05849051: Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs
Official title: Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: Cigar Warnings
Little Cigar Use
Cigar Use
Cigarillo Use
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-08
Enrollment: 1029
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: LCC Quit Intentions
timeFrame: day 21 (post test)
Secondary outcomes:
measure: Number of LCCs Smoked in Past Day
timeFrame: day 1
measure: Number of LCCs Smoked in Past Day
timeFrame: day 2
measure: Number of LCCs Smoked in Past Day
timeFrame: day 3
measure: Number of LCCs Smoked in Past Day
timeFrame: day 4
measure: Number of LCCs Smoked in Past Day
timeFrame: day 5
measure: Number of LCCs Smoked in Past Day
timeFrame: day 6
measure: Number of LCCs Smoked in Past Day
timeFrame: day 7
measure: Number of LCCs Smoked in Past Day
timeFrame: day 8
measure: Number of LCCs Smoked in Past Day
timeFrame: day 9
measure: Number of LCCs Smoked in Past Day
timeFrame: day 10
measure: Number of LCCs Smoked in Past Day
timeFrame: day 11
measure: Number of LCCs Smoked in Past Day
timeFrame: day 12
measure: Number of LCCs Smoked in Past Day
timeFrame: day 13
measure: Number of LCCs Smoked in Past Day
timeFrame: day 14
measure: Number of LCCs Smoked in Past Day
timeFrame: day 15
measure: Number of LCCs Smoked in Past Day
timeFrame: day 16
measure: Number of LCCs Smoked in Past Day
timeFrame: day 17
measure: Number of LCCs Smoked in Past Day
timeFrame: day 18
measure: Number of LCCs Smoked in Past Day
timeFrame: day 19
measure: Number of LCCs Smoked in Past Day
timeFrame: day 20
measure: Number of LCCs Smoked in Past Day
timeFrame: day 21 (post test)
measure: Number of Days Smoked LCCs in Past Week
timeFrame: day 7
measure: Number of Days Smoked LCCs in Past Week
timeFrame: day 14
measure: Number of Days Smoked LCCs in Past Week
timeFrame: day 21 (post test)
measure: Number of LCCs Smoked in the Past Week
timeFrame: day 7
measure: Number of LCCs Smoked in the Past Week
timeFrame: day 14
measure: Number of LCCs Smoked in the Past Week
timeFrame: day 21 (post test)
measure: Number of LCCs Butted Out in the Past Week
timeFrame: day 7
measure: Number of LCCs Butted Out in the Past Week
timeFrame: day 14
measure: Number of LCCs Butted Out in the Past Week
timeFrame: day 21 (post test)
measure: Number of LCCs Forgone in the Past Week
timeFrame: day 7
measure: Number of LCCs Forgone in the Past Week
timeFrame: day 14
measure: Number of LCCs Forgone in the Past Week
timeFrame: day 21 (post test)
measure: LCC Quit Attempts in Past Week
timeFrame: day 7
measure: LCC Quit Attempts in Past Week
timeFrame: day 14
measure: LCC Quit Attempts in Past Week
timeFrame: day 21 (post test)
measure: LCC Quit Intentions
timeFrame: day 7
measure: LCC Quit Intentions
timeFrame: day 14
measure: Self Reported Learning
timeFrame: day 21 (post test)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: the University of North Carolina (UNC) Department of Family Medicine
name: Adam O Goldstein
role: PRINCIPAL_INVESTIGATOR
References: