CClinicalTrials.gg
CompletedNCT04259749Updated Oct 30, 2023Results posted

Testing Legally Feasible Options: Study 1

An interventional study of Flavor Ban and Menthol Ban in Tobacco Use, sponsored by RAND. Completed at 1 site in United States. Open to participants aged 11 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by RAND · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
267
Allocation
Randomized
Ages
11 Years to 20 Years
Sex
All
01

Study 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.

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 1.

02

Conditions studied

  • Tobacco Use
03

In context

Lead sponsor

RAND is the lead sponsor of 110 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
267 participants (actual)

Study arms

  • Active comparator
    Status Quo

    The StoreLab power wall will display all tobacco products.

    Other: All flavored and mentholated products 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

  • 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 · Other: Menthol Ban

Interventions

  • OtherFlavor Ban

    Only flavored tobacco products are banned

  • OtherMenthol Ban

    Mentholated products are banned

  • OtherAll flavored and mentholated products available

    No bans: All tobacco products are available

06

What researchers measure

Primary outcomes

  1. Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)

    Self-report items: "Do you think you will try an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime soon?", "Do you think you will smoke an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarette (unflavored = cigarettes without menthol or mint), would you smoke it?". Responses to each item are made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed for a total scale score. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  2. Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)

    Self-report items: "Do you think you will try a cigarette flavored with menthol or mint anytime soon?", "Do you think you will smoke a cigarette flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarette flavored with menthol or mint, would you smoke it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Secondary outcomes

  1. Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)

    Self-report items: "Do you think you will try an unflavored vaping product soon?", "Do you think you will use an unflavored vaping product anytime in the next year?"; and "If one of your best friends offered you an unflavored vaping product would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is number of participants susceptible to using ENDS after shopping in the StoreLab (non-flavored). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  2. Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)

    Self-report items: "Do you think you will try a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor soon?", "Do you think you will use a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scaled score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  3. Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)

    Self-report items: "Do you think you will try a vaping product flavored with menthol or mint soon?", "Do you think you will use a vaping product flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  4. Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)

    Self-report items: "Do you think you will try an unflavored cigarillos/filtered cigar soon?", "Do you think you will use an unflavored cigarillos/filtered cigar anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarillos/filtered cigar, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  5. Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)

    Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor soon?", "Do you think you will use a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  6. Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored)

    Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with menthol or mint soon?", "Do you think you will use a cigarillos/filtered cigar flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number of susceptible over number in condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  7. Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored)

    Self-report items: "Do you think you will try unflavored smokeless tobacco soon?", "Do you think you will use unflavored smokeless tobacco anytime in the next year?"; and "If one of your best friends offered you unflavored smokeless tobacco, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  8. Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored)

    Self-report items: "Do you think you will try smokeless tobacco flavored with fruit soon?", "Do you think you will use smokeless tobacco flavored with fruit anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with fruit, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

  9. Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored)

    Self-report items: "Do you think you will try smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen soon?", "Do you think you will use smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

    Time frame: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

07

Results

Posted Oct 30, 2023

Participant flow

Participant flow — Overall Study
MilestoneStatus QuoFlavors BannedFlavors and Menthol Banned
Started899187
Completed899187
Not completed000

Outcome measures

PrimaryProportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)

Self-report items: "Do you think you will try an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime soon?", "Do you think you will smoke an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarette (unflavored = cigarettes without menthol or mint), would you smoke it?". Responses to each item are made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed for a total scale score. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored).18 (.10 to .30).23 (.14 to .36).33 (.21 to .48)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.40 · 95% CI 0.58 to 3.40Adjusted for age, education, lifetime use of tobacco products.
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.28 · 95% CI 0.92 to 5.63Adjusted for age, education, and lifetime use of tobacco products
PrimaryProportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)

Self-report items: "Do you think you will try a cigarette flavored with menthol or mint anytime soon?", "Do you think you will smoke a cigarette flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarette flavored with menthol or mint, would you smoke it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol).13 (.06 to .23).19 (.10 to .32).33 (.21 to .48)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.58 · 95% CI 0.61 to 4.07Adjusted for age, education, and lifetime use of tobacco products
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 3.45 · 95% CI 1.32 to 9.02Adjusted for age, education, and lifetime use of tobacco products
SecondaryProportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)

Self-report items: "Do you think you will try an unflavored vaping product soon?", "Do you think you will use an unflavored vaping product anytime in the next year?"; and "If one of your best friends offered you an unflavored vaping product would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is number of participants susceptible to using ENDS after shopping in the StoreLab (non-flavored). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored).17 (.09 to .28).23 (.13 to .36).34 (.22 to .49)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.48 · 95% CI .59 to 3.68Adjusted for age, education, and lifetime use of tobacco
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.60 · 95% CI 1.05 to 6.42Adjusted for age, education, and lifetime use of tobacco products.
SecondaryProportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)

Self-report items: "Do you think you will try a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor soon?", "Do you think you will use a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scaled score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored).34 (.22 to .48).35 (.23 to .50).42 (.28 to .57)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.08 · 95% CI .47 to 2.49Adjusted for age, education, and lifetime use of tobacco
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 1.43 · 95% CI .62 to 3.31Adjusted for age, education, and lifetime use of tobacco products
SecondaryProportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)

Self-report items: "Do you think you will try a vaping product flavored with menthol or mint soon?", "Do you think you will use a vaping product flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored).27 (.16 to .41).39 (.25 to .54).43 (.29 to .58)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.73 · 95% CI .72 to 4.14Adjusted for age, education, and lifetime use of tobacco products
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.03 · 95% CI .83 to 4.95Adjusted for age, education, and lifetime use of tobacco products.
SecondaryProportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)

Self-report items: "Do you think you will try an unflavored cigarillos/filtered cigar soon?", "Do you think you will use an unflavored cigarillos/filtered cigar anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarillos/filtered cigar, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored).09 (.04 to .19).10 (.05 to .21).17 (.09 to .31)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.13 · 95% CI .40 to 3.18Adjusted for age, education, and lifetime tobacco use
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.04 · 95% CI .73 to 5.71Adjusted for age, education, and lifetime tobacco use
SecondaryProportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)

Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor soon?", "Do you think you will use a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored).10 (.05 to .19).16 (.08 to .28).25 (.14 to .39)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.77 · 95% CI .66 to 4.75Adjusted for age, education, and lifetime tobacco use
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 3.06 · 95% CI 1.13 to 8.29Adjusted for age, education, and lifetime use of tobacco
SecondaryProportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored)

Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with menthol or mint soon?", "Do you think you will use a cigarillos/filtered cigar flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number of susceptible over number in condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored).10 (.05 to .20).13 (.07 to .25).21 (.11 to .35)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.38 · 95% CI .51 to 3.70Adjusted for age, education, and lifetime tobacco use
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.32 · 95% CI .85 to 6.31Adjusted for age, education, and lifetime tobacco use
SecondaryProportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored)

Self-report items: "Do you think you will try unflavored smokeless tobacco soon?", "Do you think you will use unflavored smokeless tobacco anytime in the next year?"; and "If one of your best friends offered you unflavored smokeless tobacco, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored).06 (.03 to .15).07 (.03 to .17).12 (.06 to .24)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.11 · 95% CI .29 to 4.26Adjusted for age, education, and lifetime tobacco use
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.00 · 95% CI .57 to 7.06Adjusted for age, education, and lifetime tobacco use
SecondaryProportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored)

Self-report items: "Do you think you will try smokeless tobacco flavored with fruit soon?", "Do you think you will use smokeless tobacco flavored with fruit anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with fruit, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored).09 (.04 to .19).10 (.04 to .20).20 (.11 to .33)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.04 · 95% CI .33 to 3.31Adjusted for age, education, and lifetime tobacco use
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.43 · .95% CI .83 to 7.13Adjusted for age, education, and lifetime tobacco use
SecondaryProportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored)

Self-report items: "Do you think you will try smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen soon?", "Do you think you will use smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Time frame:
There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.
Reported as:
Number · proportion of participants
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored)
proportion of participantsStatus QuoFlavors BannedFlavors and Menthol Banned
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored).27 (.16 to .41).39 (.25 to .54).43 (.29 to .58)
Statistical analysis
  • Status Quo vs Flavors Banned · Odds ratio (or): 1.73 · 95% CI .72 to 4.14Adjusted for age, education, and lifetime tobacco use
  • Status Quo vs Flavors and Menthol Banned · Odds ratio (or): 2.03 · 95% CI .83 to 4.95Adjusted for age, education, and lifetime tobacco use

Adverse events

Collected over Two hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Status Quo0/89 (0%)0/89 (0%)0/89 (0%)
Flavors Banned0/91 (0%)0/91 (0%)0/91 (0%)
Flavors and Menthol Banned0/87 (0%)0/87 (0%)0/87 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Status QuoFlavors BannedFlavors and Menthol BannedTotal
Mean16.73 ± 3.2316.47 ± 3.2616.56 ± 3.1116.56 ± 3.11
Sex/Gender, Customized
Sex/Gender, Customized(participants)Status QuoFlavors BannedFlavors and Menthol BannedTotal
male24283183
female616251174
other/nonbinary41510
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Status QuoFlavors BannedFlavors and Menthol BannedTotal
Hispanic or Latino64616
Not Hispanic or Latino838681250
Unknown or Not Reported0101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Status QuoFlavors BannedFlavors and Menthol BannedTotal
American Indian or Alaska Native0000
Asian13181344
Native Hawaiian or Other Pacific Islander0000
Black or African American771832
White595452165
More than one race79319
Unknown or Not Reported3317
Region of Enrollment
Region of Enrollment(participants)Status QuoFlavors BannedFlavors and Menthol BannedTotal
United States899187267
08

Study locations

1 site
  • RAND
    Pittsburgh, Pennsylvania 15213, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 16, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04259749
Lead sponsor
RAND
Responsible party
William Shadel (Senior Behavioral Scientist, RAND) — Principal investigator
First posted
Feb 6, 2020
Start date
Jan 16, 2020
Primary completion
May 31, 2022
Completion
May 31, 2022
Results posted
Oct 30, 2023
Last update
Oct 30, 2023

Study contacts

William G Shadel, PhD
principal investigator · RAND

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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