Tobacco UseNCT05604508
Testing Legally Feasible Options Studies 2/3
A study testing Many posters with prices, Many posters, no prices and Fewer posters, no price restrictions in people with Tobacco Use, run by RAND at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Many posters with prices, Many posters, no prices and Fewer posters, no price restrictions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-20, in college
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing Legally Feasible Options at Retail Point of Sale - Prices and Posters
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.
Read the 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 2 and Study 3.
- Conditions
- Tobacco Use
- Being tested
- Many posters with prices, Many posters, no prices, Fewer posters, no price restrictions
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Many posters with pricesOther
No poster number or price restrictions
Many posters, no pricesOther
No poster number restrictions, but price restrictions
Fewer posters, no price restrictionsOther
Poster number restrictions, but no price restrictions
| Study group | Role | What they receive |
|---|---|---|
| Status Quo | Active comparator | This condition will allow for many posters with pricing information to be displayed. Receives: Other: Many posters with prices |
| Reduced Poster | Experimental | This condition will allow for a reduced number of posters with pricing information to be displayed. Receives: Other: Fewer posters, no price restrictions |
| No price | Experimental | This condition will allow for many posters with no pricing information to be displayed. Receives: Other: Many posters, no prices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 10 (Definitely yes) scale and summed to produce a total smoking risk scale score (range from 3 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of cigarette smoking (number of participants at risk over number of participants within condition).
Measured: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation
Self-reported Vaping/ENDS 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 10 (Definitely yes) scale and summed to produce a total vaping risk scale score (range from 3 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of vaping (number of participants at risk over number of participants within condition).
Measured: There is one visit in this research: This variable is assessed at that visit, within 5 minutes after experimental manipulation
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 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of smokeless tobacco use (number of participants at risk over number of participants within condition).
Measured: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation
Self-reported Cigarillo/Little Cigar *LCC) Use Risk
Respondents answer the following items: "Do you think you will try a cigarillo/little cigar 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 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of LCC use (number of participants at risk over number of participants within condition).
Measured: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start12 Oct 2022
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Shadel, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604508
- Sponsor's protocol ID
- R01CA236608studies23
- Other IDs
- R01CA236608
- Status last verified
- Jan 2025
- First submitted
- 28 Oct 2022
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Legally Feasible Options at Retail Point of Sale - Prices and Posters
- ClinicalTrials.gov ID
- NCT05604508
- Acronym / sponsor ID
- R01CA236608studies23
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 2 and Study 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Status Quo | Active comparator | Other: Many posters with pricesThis condition will allow for many posters with pricing information to be displayed. |
| Reduced Poster | Experimental | Other: Fewer posters, no price restrictionsThis condition will allow for a reduced number of posters with pricing information to be displayed. |
| No price | Experimental | Other: Many posters, no pricesThis condition will allow for many posters with no pricing information to be displayed. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ages 18-20, in college
- -
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Many posters with pricesNo poster number or price restrictions | Other | Status Quo |
| Many posters, no pricesNo poster number restrictions, but price restrictions | Other | No price |
| Fewer posters, no price restrictionsPoster number restrictions, but no price restrictions | Other | Reduced Poster |
Primary outcome
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, within 5 minutes of 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 10 (Definitely yes) scale and summed to produce a total smoking risk scale score (range from 3 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of cigarette smoking (number of participants at risk over number of participants within condition).
Self-reported Vaping/ENDS Risk of Use
Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes after 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 10 (Definitely yes) scale and summed to produce a total vaping risk scale score (range from 3 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of vaping (number of participants at risk over number of participants within condition).
Self-reported Smokeless Tobacco Use Risk
Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of 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 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of smokeless tobacco use (number of participants at risk over number of participants within condition).
Self-reported Cigarillo/Little Cigar *LCC) Use Risk
Time frame: There is one visit in this research: This variable is assessed at that visit, within 5 minutes of the experimental manipulation
Respondents answer the following items: "Do you think you will try a cigarillo/little cigar 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 - 30). Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of LCC use (number of participants at risk over number of participants within condition).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Many posters with prices, Many posters, no prices and Fewer posters, no price restrictions in people with Tobacco Use, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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, within 5 minutes of the experimental manipulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.