NCT04259749

Testing Legally Feasible Options: Study 1

Completed NA Results posted Last updated 30 October 2023

What this trial tests

NA trial testing Flavor Ban in Tobacco Use in 267 participants. Completed in 31 May 2022.

Timeline

16 January 2020

Primary endpoint
31 May 2022

31 May 2022

Quick facts

Lead sponsor	RAND
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	267
Start date	16 January 2020
Primary completion	31 May 2022
Estimated completion	31 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Flavor Ban
• Menthol Ban
• All flavored and mentholated products available

Conditions studied

• Tobacco Use — all drugs for Tobacco Use →

Sponsor

RAND — full company profile →

Who can join

Adults 11 to 20, any sex, with Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored) Primary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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

Group	Value	95% CI
Status Quo	.18	.10 – .30
Flavors Banned	.23	.14 – .36
Flavors and Menthol Banned	.33	.21 – .48

Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol) Primary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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). Pr

Group	Value	95% CI
Status Quo	.13	.06 – .23
Flavors Banned	.19	.10 – .32
Flavors and Menthol Banned	.33	.21 – .48

Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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

Group	Value	95% CI
Status Quo	.17	.09 – .28
Flavors Banned	.23	.13 – .36
Flavors and Menthol Banned	.34	.22 – .49

Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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.

Group	Value	95% CI
Status Quo	.34	.22 – .48
Flavors Banned	.35	.23 – .50
Flavors and Menthol Banned	.42	.28 – .57

Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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).

Group	Value	95% CI
Status Quo	.27	.16 – .41
Flavors Banned	.39	.25 – .54
Flavors and Menthol Banned	.43	.29 – .58

Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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 proportio

Group	Value	95% CI
Status Quo	.09	.04 – .19
Flavors Banned	.10	.05 – .21
Flavors and Menthol Banned	.17	.09 – .31

Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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 dichotom

Group	Value	95% CI
Status Quo	.10	.05 – .19
Flavors Banned	.16	.08 – .28
Flavors and Menthol Banned	.25	.14 – .39

Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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'

Group	Value	95% CI
Status Quo	.10	.05 – .20
Flavors Banned	.13	.07 – .25
Flavors and Menthol Banned	.21	.11 – .35

Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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 outcom

Group	Value	95% CI
Status Quo	.06	.03 – .15
Flavors Banned	.07	.03 – .17
Flavors and Menthol Banned	.12	.06 – .24

Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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

Group	Value	95% CI
Status Quo	.09	.04 – .19
Flavors Banned	.10	.04 – .20
Flavors and Menthol Banned	.20	.11 – .33

Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored) Secondary · There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

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

Group	Value	95% CI
Status Quo	.27	.16 – .41
Flavors Banned	.39	.25 – .54
Flavors and Menthol Banned	.43	.29 – .58

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.