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Testing Legally Feasible Options: Study 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04259749
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
William Shadel, RAND

Brief 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 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Other: Flavor Ban Other: Menthol Ban Other: All flavored and mentholated products available Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Experimentally Testing Legally Feasible Regulatory Options for Reducing the Impact of the Point-of-sale Retail Environment on Adolescent Tobacco Use
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Active Comparator: Status Quo
The StoreLab power wall will display all tobacco products.
Other: All flavored and mentholated products available
No bans: All tobacco products are available

Experimental: Flavors Banned
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed.
Other: Flavor Ban
Only flavored tobacco products are banned

Experimental: Flavors and Menthol Banned
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed.
Other: Flavor Ban
Only flavored tobacco products are banned

Other: Menthol Ban
Mentholated products are banned




Primary Outcome Measures :
  1. Self-reported cigarette smoking risk after shopping in the StoreLab [ Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation. ]
    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.

  2. Self-reported vaping/ENDDS risk of use [ Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation. ]
    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.

  3. Self-reported smokeless tobacco use risk [ Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation. ]
    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.

  4. Self-reported cigarillo use risk [ Time Frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 11-17, parental consent/adolescent assent

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259749


Contacts
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Contact: William G Shadel, PhD 412-683-2300 ext 4489 shadel@rand.org

Locations
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United States, Pennsylvania
RAND Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: William G Shadel, PhD    412-683-2300 ext 4489    shadel@rand.org   
Sponsors and Collaborators
RAND
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Responsible Party: William Shadel, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT04259749    
Other Study ID Numbers: R01CA236608 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents