The Impact of Cigarillo Warnings on Purchasing

NCT05434013 | Completed Results

• 2 other identifiers: NE-1R01CA260460
• Study Type: interventional
• Target: 1,578
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether different cigarillo warning formats (pictorial, FDA-proposed text-only, current Surgeon General text-only) reduces demand for cigarillos. A previous study has identified that pictorial cigarillo warnings are perceived as more effective, but more information is needed on their impact. This study will address this issue by randomizing participants to see different cigarillo warning formats on cigarillo products within an online experimental tobacco marketplace. Participants will be cigarillo users who are ages 21-35.

Conditions

Cigar Smoking

Keywords

Cigarillo smoking; Cigarillo packaging warnings

Outcome Measures

Primary Outcomes (1)

• Average Total Number of Cigarillos Purchased

  Participants in each arm will participate in six mock shopping trips with a specified budget. They will purchase (mock) single cigarillos. The primary outcome is the average number of cigarillos purchased during each of the six mock shopping trips.

  Within the 20-minute survey

Secondary Outcomes (5)

• Average Total Amount of mg Combusted Tobacco Purchased

  Within the 20-minute survey

• Average Total Amount of mg Non-combusted Tobacco Purchased

  Within the 20-minute survey

• Intensity Index for Cigarillos

  Within the 20 minute survey.

• Cost Related Indices for Cigarillos

  Within the 20-minute survey

• Rate of Change for Cigarillo Demand

  Within the 20-minute survey

Other Outcomes (8)

• Negative Affect

  Within the 20-minute survey

• Cognitive Elaboration

  Within the 20-minute survey

• Intentions to Quit Using Cigarillos

  Within the 20-minute survey

Study Arms (3)

Cigarillo warnings-Surgeon General Text-Only

EXPERIMENTAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.

Behavioral: Cigarillo warnings-Surgeon General Text-Only

Cigarillo warnings-FDA proposed text-only

EXPERIMENTAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.

Behavioral: Cigarillo warnings-FDA proposed text-only

Cigarillo warnings-Pictorial

EXPERIMENTAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.

Behavioral: Cigarillo warnings-Pictorial

Interventions

Cigarillo warnings-Surgeon General Text-Only BEHAVIORAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.

Cigarillo warnings-Surgeon General Text-Only

Cigarillo warnings-FDA proposed text-only BEHAVIORAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.

Cigarillo warnings-FDA proposed text-only

Cigarillo warnings-Pictorial BEHAVIORAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.

Cigarillo warnings-Pictorial

Eligibility Criteria

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

You may qualify if:

• Current cigarillo users: used cigarillos at least one time per week in the past month
• Members of the Kantar Media panel

You may not qualify if:

• Non-English speakers
• Non-current cigarillo users
• Not members of Kantar Media

Sponsors & Collaborators

• Boston University: lead
• Brown University: collaborator
• National Institutes of Health (NIH): collaborator
• Food and Drug Administration (FDA): collaborator
• National Cancer Institute (NCI): collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, 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: BU School of Public Health

jjross@bu.edu

617 358 1905

Study Officials

• Jennifer C Ross, PhD

  BU School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to one of 3 conditions. In each of these conditions participants will see one of the following warning label formats on the cigarillos when they are shopping for tobacco products: a pictorial warning, a text-based warning, or a surgeon general warning. Participants don't know which condition they're assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will conduct a three-group, between-subjects experiment to compare varying cigarillo warning formats: Surgeon General text-only, FDA-proposed text-only, and study developed pictorial cigarillo warning labels.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: June 24, 2022
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 9-36 months following publication
• Access Criteria: Qualified researchers engaged in independent scientific research with IRB approval and a data use agreement with Wake Forest University Health Sciences.

Locations

US (1)