N/A
N=25
Effects of Cigarette and E-cigarette Flavors on Substitutability in the ETM
Cigarette Smoking Behavior
Bottom Line
View on ClinicalTrials.gov: NCT06910202 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Nicotine/Tobacco Products Substitution — 1326.25; 206; 120.83; 46.79 mg of nicotine purchased
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manipulation of nicotine/tobacco product price and availability (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine/Tobacco Products Substitution |
1326.25; 206; 120.83; 46.79; 2177.2; 528 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06910202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.