Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Tobacco Use

Treatments: Behavioral: FDA proposed text-only warnings at 30% size; Behavioral: Newly developed warnings with images at 30% size

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05849051

22-2531

R01CA240732 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,029 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,029 participants in 3 patient groups

Newly developed warnings with images

Experimental group

Description:

Participants receive newly developed warnings intervention

Treatment:

Behavioral: Newly developed warnings with images at 30% size

FDA proposed text-only warnings

Experimental group

Description:

Participants receive FDA proposed text only warning intervention

Treatment:

Behavioral: FDA proposed text-only warnings at 30% size

Control group, no intervention

No Intervention group

Description:

Participants do not receive an intervention