Testing Legally Feasible Options Studies 2/3

Tobacco Use Clinical Trial

Official title:

Testing Legally Feasible Options at Retail Point of Sale - Prices and Posters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604508
• Other study ID #: R01CA236608studies23
• Secondary ID: R01CA236608
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: RAND
• Contact: William G Shadel, PhD
• Phone: 14126832300
• Email: shadel[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of this research is to experimentally evaluate different, legally-viable approaches to reducing the impact of the point-of-sale (POS) retail environment on adolescent tobacco use risk. This study will be investigating regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos). Study 2 and study 3 (out of 3 studies), occurring concurrently, will examine whether changing the number and content of posters on the outside doors at POS reduced adolescents' tobacco use risk.

Description:

Tobacco advertising at retail point-of-sale (POS) includes promotional allowances that permit tobacco products to be advertised and sold at reduced cost to consumers (e.g., two-for-one specials); high visibility sale and therefore placement of hundreds of tobacco products on power walls; and the display of a large, diverse collection of poster advertisements on the exterior of the stores. Adolescents are at significant risk for having repeated exposures to this tobacco rich POS environment and such exposures contribute to increases in adolescent tobacco use. Although curbing the effect of the tobacco rich POS environment on adolescent tobacco use is a critical public health goal, some POS advertising regulations are unlikely to be viable in the United States because they impinge upon the tobacco industry's commercial free speech rights. For example, eliminating the tobacco power wall is probably not a viable option in the US as it has been successfully challenged in court by the tobacco industry. POS regulations that do not violate the industry's commercial free speech rights stand a better chance of being upheld by the courts. For example, eliminating tobacco product price promotions, reducing the availability of tobacco products by restricting the sale of flavored products, and restricting how much door/window space tobacco product posters can occupy at POS, all have been implemented as feasible and legally defensible regulatory options at POS. The evidence base supporting the efficacy of these initiatives is, however, almost non-existent - leaving them open to legal scrutiny. The overall aim of this research is to experimentally evaluate different, legally-viable approaches to reducing the impact of the POS retail environment on adolescent tobacco use risk. This research will be investigating the regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos): the extent to which eliminating tobacco product price promotions (Study 2), restricting how much door/window space tobacco posters can occupy at POS (Study 3), and eliminating the sale of flavored and/or mentholated tobacco products (Study 1) reduce adolescent tobacco-use risk. Each study will evaluate for possible gender and race (African-American vs Caucasian) differences. The studies will take place in the RAND StoreLab, a life-sized replica of a convenience store that was developed to experimentally evaluate how altering aspects of tobacco promotion at POS influences tobacco use. The present record is for Study 2 and Study 3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 20 Years

Eligibility

Inclusion Criteria:

ages 18-20, in college - Exclusion Criteria: any medical or psychiatric condition which would make compliance with the study protocol difficult (based on parent report). Previous participation in a previous StoreLab study

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Many posters with prices
No poster number or price restrictions
• Many posters, no prices
No poster number restrictions, but price restrictions
• Fewer posters, no price restrictions
Poster number restrictions, but no price restrictions

Locations

Country	Name	City	State
United States	RAND Corporation	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported cigarette smoking risk after shopping in the StoreLab	Respondents answer the following items: "Do you think you will try a cigarette anytime soon?", "Do you think you will try a cigarette anytime in the next year?"; and "If one of your best friends offered you a cigarette, would you smoke it?". Responses are made on a 1 (Definitely not) to 4 (Definitely yes) scale and summed to produce a total smoking risk scale score (range from 3 - 12). Higher scores reflect greater risk.	There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation
Primary	Self-reported vaping/ENDDS risk of use	Respondents answer the following items: "Do you think you will try a vaping product anytime soon?", "Do you think you will try a vaping product anytime in the next year?"; and "If one of your best friends offered you a vaping product, would you use it?". Responses are made on a 1 (Definitely not) to 4 (Definitely yes) scale and summed to produce a total vaping risk scale score (range from 3 - 12). Higher scores reflect greater risk.	There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation
Primary	Self-reported smokeless tobacco use risk	Respondents answer the following items: "Do you think you will use smokeless tobacco anytime soon?", "Do you think you will try smokeless tobacco anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco, would you use it?". Responses are made on a 1 (Definitely not) to 4 (Definitely yes) scale and summed to produce a total smokeless tobacco risk scale score (range from 3 - 12). Higher scores reflect greater risk.	There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation
Primary	Self-reported cigarillo use risk	Respondents answer the following items: "Do you think you will try a cigarillo anytime soon?", "Do you think you will try a cigarillo anytime in the next year?"; and "If one of your best friends offered you a cigarillo, would you smoke it?". Responses are made on a 1 (Definitely not) to 4 (Definitely yes) scale and summed to produce a total cigarillo risk scale score (range from 3 - 12). Higher scores reflect greater risk.	There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation