Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs

NCT05849051 | Completed Results

• 2 other identifiers: 22-2531R01CA240732
• Study Type: interventional
• Target: 1,029
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use

Keywords

Cigar Warnings; Little Cigar Use; Cigar Use; Cigarillo Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (39)

• Number of LCCs Smoked in Past Day

  day 1

• Number of LCCs Smoked in Past Day

  day 2

• Number of LCCs Smoked in Past Day

  day 3

• Number of LCCs Smoked in Past Day

  day 4

• Number of LCCs Smoked in Past Day

  day 5

Study Arms (3)

Newly developed warnings with images

EXPERIMENTAL

Participants receive newly developed warnings intervention

Behavioral: Newly developed warnings with images at 30% size

FDA proposed text-only warnings

EXPERIMENTAL

Participants receive FDA proposed text only warning intervention

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

Control group, no intervention

NO INTERVENTION

Participants do not receive an intervention

Interventions

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.

Newly developed warnings with images

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.

FDA proposed text-only warnings

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Goldstein AO, Jarman KL, Ranney LM, Cornacchione Ross J, Kowitt SD, Enyioha C, Clark SA, Sheeran P, Thrasher JF, Jenson D, Vielot NA. Little Cigar and Cigarillo Graphic Health Warnings and Quitting Behaviors: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526799. doi: 10.1001/jamanetworkopen.2025.26799.

  PMID: 40815515 DERIVED

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Adam O Goldstein
• Organization: UNC Lineberger Comprehensive Cancer Center

AOG@med.unc.edu

919-270-6491

Study Officials

• Adam O Goldstein

  the University of North Carolina (UNC) Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 8, 2023
• Study Start: May 22, 2023
• Primary Completion: August 27, 2023
• Study Completion: August 27, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The supporting documents and data will become available when study results are submitted to ClinicalTrials.gov. Deidentified study data sets will be available, by request, following publication of the study's main findings.
• Access Criteria: The investigators will decide whether to share deidentified study data sets on a case by case basis, and will prioritize sharing the data sets with qualified tobacco regulatory science researchers.

Locations

US (1)