Effects of Cigarette and E-cigarette Flavors on Substitutability in the ETM

NCT06910202 | Completed Results

• 2 other identifiers: VT IRB #25-1855P01CA200512-09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In 2009, the FDA banned all flavored conventional cigarettes except menthol. While no such ban exists for e-cigarettes, proposals have emerged in several regions. Flavors are key targets for tobacco control policy, making it crucial to understand their role in substitution.The first wave of the PATH study found that 80% of youth, 73% of young adults, and 29% of older smokers used flavored products. Over 80% of young adults first used flavored tobacco, compared to about 50% of adults. Among ever-users, current tobacco use was 32% higher if their first product was flavored.One study reported that 75% of flavored product users would quit if flavors were removed. These findings highlight the importance of user type in shaping policy and raise the question of whether banning flavors would increase quitting or drive substitution. The Experimental Tobacco Marketplace (ETM) is a novel method for estimating the effects of new tobacco policies and products on consumption and substitution. By experimentally controlling product mix, prices, and policies, ETM simulates "real-world" conditions to assess potential policy impacts.This methodology has been used to study various policies in adult smokers under this grant: nicotine dose variations (Study 1), tobacco taxes and subsidies (Study 2), and workplace restrictions (Study 3). Study 1 found that cigarette and e-cigarette substitutability increased with e-liquid nicotine strength, with 24mg/mL showing the highest substitution. Study 2 showed that cigarette taxes reduced cigarette purchases and increased e-liquid purchases, while e-liquid subsidies increased e-liquid purchases but did not affect cigarette consumption. No study to date has experimentally examined the effects of flavored tobacco products availability on consumer behavior. The rationale for this specific proposal is to explore prospectively the possible consequences of a flavor ban on consumption and substitution with tobacco products. The results might inform tobacco control policies.

Conditions

Cigarette Smoking Behavior

Keywords

Cigarettes; E-cigarettes; Experimental Tobacco Marketplace; Substitutability; Flavors

Outcome Measures

Primary Outcomes (1)

• Nicotine/Tobacco Products Substitution

  The outcome measure of substitution will be collected and modeled using a virtual store. Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price (cigarette type depending on condition). Other product prices will remain at market price. Substitutability occurs as a function of different flavor conditions. The degree to which other nicotine/tobacco products substitute for usual cigarettes under varying price and flavor restriction conditions will be assessed. Mixed-effects hierarchical linear regression will be used to evaluate purchasing behavior. The model includes a three-way interaction (cigarette policy × e-cigarette policy × log(price)) and a random effect for participant. Model selection based on Bayesian Information Criterion (BIC).

  During the intervention, session 2 (1 day per participant)

Study Arms (1)

Menthol cigarette smokers

EXPERIMENTAL

Menthol cigarette smokers will complete questionnaires on a computer, sample a range of tobacco products, and purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.

Behavioral: Manipulation of nicotine/tobacco product price and availability

Interventions

Manipulation of nicotine/tobacco product price and availability BEHAVIORAL

This study does involve experimental manipulation of nicotine/tobacco product price and availability to understand consumers' behavior. Participants will be provided with a commercially available e-cigarette to use during the study, if they wish. Every participant will purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.

Menthol cigarette smokers

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 21 and 65 years of age
• Cigarette smokers
• Smoke cigarettes daily (≥ 5 cigarettes/day)
• Do not use e-cigarettes regularly (no more than 9 times in the last month)
• Be willing to try e-cigarettes

You may not qualify if:

• Pregnant or lactating women
• Plans to move out of the area
• Use of prescription medication that might affect smoking or nicotine metabolism
• Unmanaged medical or psychiatric conditions
• Plans to quit smoking within the next 30 days
• This study will focus on cigarette smokers and dual users. We will not include individuals under the age of 21 in compliance with Virginia state law. Minors, pregnant women, prisoners, and adults not capable to consent on their own behalf will be excluded from this study.
• Minors, as defined by state law where the study is performed (infants, children, teenagers)
• Pregnant women (can be included in minimal risk studies by mentioning in section 13.1)
• Prisoners (including all incarcerated individuals)
• Adults not capable to consent on their own behalf

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• National Cancer Institute (NCI): collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Related Publications (8)

• Pope DA, Poe L, Stein JS, Kaplan BA, DeHart WB, Mellis AM, Heckman BW, Epstein LH, Chaloupka FJ, Bickel WK. The Experimental Tobacco Marketplace: Demand and Substitutability as a Function of Cigarette Taxes and e-Liquid Subsidies. Nicotine Tob Res. 2020 Apr 21;22(5):782-790. doi: 10.1093/ntr/ntz116.

  PMID: 31350894 BACKGROUND

• Pope DA, Poe L, Stein JS, Kaplan BA, Heckman BW, Epstein LH, Bickel WK. Experimental tobacco marketplace: substitutability of e-cigarette liquid for cigarettes as a function of nicotine strength. Tob Control. 2019 Mar;28(2):206-211. doi: 10.1136/tobaccocontrol-2017-054024. Epub 2018 Apr 18.

  PMID: 29669748 BACKGROUND

• Bickel WK, Pope DA, Kaplan BA, DeHart WB, Koffarnus MN, Stein JS. Electronic cigarette substitution in the experimental tobacco marketplace: A review. Prev Med. 2018 Dec;117:98-106. doi: 10.1016/j.ypmed.2018.04.026. Epub 2018 Apr 24.

  PMID: 29702131 BACKGROUND

• Harrell MB, Loukas A, Jackson CD, Marti CN, Perry CL. Flavored Tobacco Product Use among Youth and Young Adults: What if Flavors Didn't Exist? Tob Regul Sci. 2017 Apr;3(2):168-173. doi: 10.18001/TRS.3.2.4.

  PMID: 28775996 BACKGROUND

• Villanti AC, Johnson AL, Ambrose BK, Cummings KM, Stanton CA, Rose SW, Feirman SP, Tworek C, Glasser AM, Pearson JL, Cohn AM, Conway KP, Niaura RS, Bansal-Travers M, Hyland A. Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014). Am J Prev Med. 2017 Aug;53(2):139-151. doi: 10.1016/j.amepre.2017.01.026. Epub 2017 Mar 16.

  PMID: 28318902 BACKGROUND

• Providenceri.com. Providence Tobacco Laws Go Into Effect January 3. Healthy Communities 2013. https://www.providenceri.com/healthy-communities/providence-tobacco-laws-go-into-effect-january-3.

  BACKGROUND

• FOX32News. Illinois attorney general: ban e-cigarette flavors. 2014. http://www.myfoxchicago.com/story/26238470/illinois-attorney-general-ban-e-cigarette-flavors. Accessed 11-3-14.

  BACKGROUND

• Durkin E. Bill would ban sale of flavored e-cigarettes. Celeste Katz Daily Politics. New York: New York Daily News; 2014.

  BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Limitations and Caveats

This project is a secondary analysis of data originally collected under IRB#20-008. The study was originally designed as a four-arm trial with 100 planned participants and began before COVID-19. Due to funding and safety constraints, data were collected only from exclusive smokers (n=25). Seven cases were lost due to a survey error and treated as missing at random, and we had some trials with only 24 data points for analysis. The secondary analysis protocol was approved (VT IRB#25-185).

Results Point of Contact

• Title: Dr. Roberta Freitas Lemos
• Organization: Fralin Biomedical Research Institute at VTC

rflemos@vtc.vt.edu

5405262106

Study Officials

• Roberta Freitas Lemos, Ph.D.

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 4, 2025
• Study Start: July 8, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 25, 2022
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)