Cigarillo Warnings Image Sorting Study

NCT05838378 | Completed Results

• 2 other identifiers: H-43316R01CA260460
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format. For 4 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of \~18 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert). At the end of the study, participants will be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation. The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.

Conditions

Smoking, Cigar

Keywords

Current cigarillo user; Cigar/cigarillo quit intentions; Pictorial warning format; Surgeon General text warning format; FDA text warning format

Outcome Measures

Primary Outcomes (1)

• Intention to Quit Smoking Cigarillos in the Next 30 Days at Weeks 2-4

  Assessed by the score for 3 survey items: 1) how interested participants are in quitting cigarillo smoking in the next 30 days; 2) how likely they are to quit smoking cigarillos in the next 30 days; and 3) how much they plan to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely). All items are averaged to create a composite quit intentions score which can range from 1 to 5. Higher scores are associated with a greater intention to quit.

  Weeks 2-4

Secondary Outcomes (4)

• Interest Cutting Smoking

  Weeks 2-4

• Number of Participants in Week 2 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week

  Week 2

• Number of Participants in Week 3 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week

  Week 3

• Number of Participants in Week 4 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week

  week 4

Other Outcomes (11)

• Quitting Self-efficacy Based on Anticipated Success

  Weeks 2-4

• Quitting Stages of Change on a Quit Ladder

  Weeks 2-4

• Warning Recall

  Week 4

Study Arms (3)

Pictorial warnings

EXPERIMENTAL

Participants randomized to this group will view pictorial cigarillo warnings.

Other: Package image sorting with pictorial warnings

FDA text-only warnings

ACTIVE COMPARATOR

Participants randomized to this group will view FDA text-only warnings.

Other: Package image sorting with FDA text-only warnings

Surgeon General text-only warnings

ACTIVE COMPARATOR

Participants randomized to this group will view Surgeon General text-only warnings.

Other: Package image sorting with Surgeon General text-only warnings

Interventions

Package image sorting with FDA text-only warnings OTHER

Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories \[fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other\]. Participants will sort 18 images of cigarillo packages from various brands with FDA text-only warnings on each pack.

FDA text-only warnings

Package image sorting with pictorial warnings OTHER

Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories \[fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other\]. Participants will sort 18 images of cigarillo packages from various brands with pictorial warnings on each pack.

Pictorial warnings

Package image sorting with Surgeon General text-only warnings OTHER

Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories \[fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other\]. Participants will sort 18 images of cigarillo packages from various brands with Surgeon General text-only warnings on each pack.

Surgeon General text-only warnings

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current cigarillo user-used cigarillos at least one time per week in the past month
• Recruited through Qualtrics Research Services

You may not qualify if:

• Not recruited through Qualtrics Research Services
• Non-English speaking

Sponsors & Collaborators

• Boston University: lead
• National Cancer Institute (NCI): collaborator
• Wake Forest University Health Sciences: collaborator
• Brown University: collaborator

Study Sites (1)

Boston University School of Public Health, study online

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Cigar Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Jennifer Ross, PhD
• Organization: Boston University School of Public Health, Health Law Policy & Management Dept

jjross@bu.edu

(617) 358-1905

Study Officials

• Jennifer Ross, PhD

  School of Public Health - Health Law Policy & Management Dept

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 18, 2023
• First Posted: May 1, 2023
• Study Start: January 14, 2025
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)