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Testing Legally Feasible Options: Study 1

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RanD

Status

Completed

Conditions

Tobacco Use

Treatments

Other: All flavored and mentholated products available
Other: Flavor Ban
Other: Menthol Ban

Study type

Interventional

Funder types

Other

Identifiers

NCT04259749
R01CA236608

Details and patient eligibility

About

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 the regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos). Study 1 (study 1 out of 3 proposed) will examine whether eliminating the sale of flavored tobacco products at POS reduced adolescents' tobacco use risk.

Full 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 1.

Enrollment

267 patients

Sex

All

Ages

11 to 20 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ages 11-20, parental consent/adolescent assent for minors

Exclusion criteria

  • any medical or psychiatric condition which would make compliance with the study protocol difficult (based on parent report).
  • Previous participation (by either adolescent or parent) in a previous StoreLab study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

267 participants in 3 patient groups

Status Quo
Active Comparator group
Description:
The StoreLab power wall will display all tobacco products.
Treatment:
Other: All flavored and mentholated products available
Flavors Banned
Experimental group
Description:
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed.
Treatment:
Other: Flavor Ban
Flavors and Menthol Banned
Experimental group
Description:
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed.
Treatment:
Other: Menthol Ban
Other: Flavor Ban

Trial documents
1

Trial contacts and locations

1

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Central trial contact

William G Shadel, PhD

Data sourced from clinicaltrials.gov

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