Cigarillo Warnings Image Sorting Study

Smoking, Cigar Clinical Trial

Official title:

The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users, Aim 2 Survey

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05838378
• Other study ID #: H-43316
• Secondary ID: R01CA260460
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Boston University
• Contact: Jennifer Ross, PhD
• Phone: (617) 358-1905
• Email: jjross[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• Current cigarillo user-used cigarillos at least one time per week in the past month

• Recruited through Qualtrics Research Services

Exclusion Criteria:

• Not recruited through Qualtrics Research Services

• Non-English speaking

Related Conditions & MeSH terms

• Smoking, Cigar

Intervention

Other:
• Package image sorting with pictorial warnings
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.
• Package image sorting with Surgeon General text-only warnings
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.
• Package image sorting with FDA text-only warnings
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.

Locations

Country	Name	City	State
United States	Boston University School of Public Health, study online	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Brown University, National Cancer Institute (NCI), Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quitting self-efficacy based on anticipated success	Assessed by a single survey item asking how successful participants think they would be if they tried to quit smoking in the next 30 days. The survey item has a 5-pt response scale (0=Not at all to 5= Extremely).	Baseline, Weeks 2-4
Other	Quitting stages of change on a quit ladder	Assessed by an image of a quit ladder, asking participants where they are now on the ladder in regards to cigarillo smoking (1 no thought of quitting - 10 taking action to quit).	Baseline, Weeks 2-4
Other	Warning recall	Assessed by one survey item asking participants if they noticed any health warnings on the cigarillo packages during the study, with response options of Yes, No, and I'm not sure. Recall is defined as a "Yes" response.	Baseline, Weeks 2-4
Other	Warning recognition	Assessed by one survey item asking participants to identify which warning they saw during the study period. Participants will be shown their warning, a warning they did not see, and "I don't know" response options. Selecting the correct warning indicates warning recognition.	Baseline, Weeks 2-4
Other	Warning reactions	Assessed by four survey items assessing participants' perceptions of the warning for 1) grabbing attention; 2) eliciting disgust/emotions; 3) thinking about the risks; 4) self-reported learning. Response options from 1 = not at all to 5 = very much.	Baseline, Weeks 2-4
Other	Beliefs about harms associated with cigarillo smoking	Assessed by 11 survey items on participant's beliefs about the harms associated with cigarillo smoking, such as relative risk to cigarettes, getting cancer, and inhaling harmful chemicals. 5 point response scale (1=strongly disagree to 5=strongly agree). Higher scores are associated with stronger beliefs about the harms associated with cigarillo smoking.	Baseline, Weeks 2-4
Other	Knowledge about harms associated with cigarillo smoking	Assessed by 10 survey items on participant's knowledge about the harms associated with cigarillo smoking, such as cigarillos being addictive and causing heart disease with three response options: True, False, I don't know.	Baseline, Weeks 2-4
Other	Social interactions	Assessed with 3 survey items about: 1) the frequency in which participants talked to others about the harms of cigarillo smoking, 20 quitting cigarillo smoking, or 3) about the packages in the study. Response options range from 1 = never to 5 = 10 times or more.	Week 4
Other	Warning Relevance	Assessed with 2 survey items about participants' perceptions about the relevance of the cigarillo warning for those who smoke cigarillos with cannabis (i.e., blunts). 5 response options from 1 = not at all to 5 = very much.	Week 4
Primary	Intention to quit smoking cigarillos in the next 30 days at baseline	Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried 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).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit.	Baseline
Primary	Intention to quit smoking cigarillos in the next 30 days at weeks 2-4	Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried 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).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit.	Weeks 2-4
Secondary	Cigarillo smoking behavior in the past week	Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking?	Baseline, Weeks 2-4