Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849051
• Other study ID #: 22-2531
• Secondary ID: R01CA240732
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: August 27, 2023

Study information

• Verified date: October 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. To collect at least 750 quality completes the investigators anticipate enrolling up to 3,000 people.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: August 27, 2023
• Est. primary completion date: August 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• Newly developed warnings with images at 30% size
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
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LCC quit intentions	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.	day 21 (post test)
Secondary	Number of LCCs smoked in past day	Measured by survey	day 1
Secondary	Number of LCCs smoked in past day	Measured by survey	day 2
Secondary	Number of LCCs smoked in past day	Measured by survey	day 3
Secondary	Number of LCCs smoked in past day	Measured by survey	day 4
Secondary	Number of LCCs smoked in past day	Measured by survey	day 5
Secondary	Number of LCCs smoked in past day	Measured by survey	day 6
Secondary	Number of LCCs smoked in past day	Measured by survey	day 7
Secondary	Number of LCCs smoked in past day	Measured by survey	day 8
Secondary	Number of LCCs smoked in past day	Measured by survey	day 9
Secondary	Number of LCCs smoked in past day	Measured by survey	day 10
Secondary	Number of LCCs smoked in past day	Measured by survey	day 11
Secondary	Number of LCCs smoked in past day	Measured by survey	day 12
Secondary	Number of LCCs smoked in past day	Measured by survey	day 13
Secondary	Number of LCCs smoked in past day	Measured by survey	day 14
Secondary	Number of LCCs smoked in past day	Measured by survey	day 15
Secondary	Number of LCCs smoked in past day	Measured by survey	day 16
Secondary	Number of LCCs smoked in past day	Measured by survey	day 17
Secondary	Number of LCCs smoked in past day	Measured by survey	day 18
Secondary	Number of LCCs smoked in past day	Measured by survey	day 19
Secondary	Number of LCCs smoked in past day	Measured by survey	day 20
Secondary	Number of LCCs smoked in past day	Measured by survey	day 21 (post test)
Secondary	Number of days smoked LCCs in past week	Measured by survey	day 7
Secondary	Number of days smoked LCCs in past week	Measured by survey	day 14
Secondary	Number of days smoked LCCs in past week	Measured by survey	day 21 (post test)
Secondary	Number of LCCs smoked in the past week	Measured by survey	day 7
Secondary	Number of LCCs smoked in the past week	Measured by survey	day 14
Secondary	Number of LCCs smoked in the past week	Measured by survey	day 21 (post test)
Secondary	Number of LCCs butted out in the past week	Measured by survey	day 7
Secondary	Number of LCCs butted out in the past week	Measured by survey	day 14
Secondary	Number of LCCs butted out in the past week	Measured by survey	day 21 (post test)
Secondary	Number of LCCs forgone in the past week	Measured by survey	day 7
Secondary	Number of LCCs forgone in the past week	Measured by survey	day 14
Secondary	Number of LCCs forgone in the past week	Measured by survey	day 21 (post test)
Secondary	LCC quit attempts in past week	Measured by survey	day 7
Secondary	LCC quit attempts in past week	Measured by survey	day 14
Secondary	LCC quit attempts in past week	Measured by survey	day 21 (post test)
Secondary	LCC quit intentions	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.	day 7
Secondary	LCC quit intentions	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.	day 14
Secondary	Self reported learning	Measured by survey. 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.	day 21 (post test)

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials