Clinical trial NCT05434013: The Impact of Cigarillo Warnings on Purchasing
Official title: The Impact of Cigarillo Warnings on Purchasing Behaviors Among Young Adult Cigarillo Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigar Smoking
Keywords: Cigarillo smoking
Cigarillo packaging warnings
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institutes of Health (NIH)
name: Food and Drug Administration (FDA)
name: National Cancer Institute (NCI)
name: Wake Forest University Health Sciences
First posted: 2022-06-27
Enrollment: 1578
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Warning labels on tobacco products convey the health risks and discourage use. Warnings are even more effective when they contain images that depict the health consequences. However, little is known about the impact of cigarillo warnings, including pictorial warnings, on consumer behavior. The Experimental Tobacco Marketplace (ETM) task examines the effects of regulations on tobacco purchasing in the context of a complex tobacco marketplace. This project aims to address the gap in the knowledge about cigarillo risk communication by providing information on best practices for cigarillo warnings. Identifying effective cigarillo warnings is important to inform policy and guide research on effectively communicating risk to ultimately decrease use and tobacco-related morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Average Total Number of Cigarillos Purchased
timeFrame: Within the 20-minute survey
Secondary outcomes:
measure: Average Total Amount of mg Combusted Tobacco Purchased
timeFrame: Within the 20-minute survey
measure: Average Total Amount of mg Non-combusted Tobacco Purchased
timeFrame: Within the 20-minute survey
measure: Intensity Index for Cigarillos
timeFrame: Within the 20 minute survey.
measure: Cost Related Indices for Cigarillos
timeFrame: Within the 20-minute survey
measure: Rate of Change for Cigarillo Demand
timeFrame: Within the 20-minute survey
Other outcomes:
measure: Negative Affect
timeFrame: Within the 20-minute survey
measure: Cognitive Elaboration
timeFrame: Within the 20-minute survey
measure: Intentions to Quit Using Cigarillos
timeFrame: Within the 20-minute survey
measure: Warning Recall
timeFrame: Within the 20-minute survey
measure: Warning Recognition
timeFrame: Within the 20-minute survey
measure: Mean Perceived Message Effectiveness
timeFrame: Within the 20-minute survey
measure: Self-Reported Learning
timeFrame: Within the 20-minute survey
measure: Average Total Amount of Non-tobacco Products Purchased
timeFrame: Within the 20-minute survey
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: BU School of Public Health
name: Jennifer C Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References: