Cigarette Smoking Behavior
Conditions
Keywords
Cigarettes, E-cigarettes, Experimental Tobacco Marketplace, Substitutability, Flavors
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.
Detailed description
This study does not involve any smoking cessation interventions. 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. This study uses a within subject design. 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. Participants will complete a 1) consent and assessment session, and a product sampling phase, 2) an ETM session and a 3) follow-up session: In the consent and initial assessment session, participants will go through standard consent procedures and then provide a breath sample to confirm recent levels of smoking. They may be asked to provide a urine sample for an analysis of cotinine content. Participants will complete a timeline follow back to assess previous month's recent smoking, e-cigarette use, and consumption of nicotine products, and to determine the ETM budget. A Qualtrics survey will administer demographics questions, smoking assessments (Questionnaire on Smoking Urges-Brief, Minnesota Nicotine Withdrawal Scale, Fagerstrom Test of Nicotine Dependence, Perceived Health Risk for cigarettes and e-cigarettes), and delay discounting tasks. At the end of the session, participants will experience a trial of the ETM that will be used in the next session. For the 7-day sampling phase, they will be provided a list of available flavors and identify 5 that they would like to try. They will leave with a sample of each of the 5 flavors to try during the next few days. Participants will also be provided with a sample of any other tobacco product they wish to examine and try. They may sample any products in the smoking lab before they leave. In the ETM session, participants will buy tobacco products to use throughout the next 7 days. Participants will complete a total of 40 purchasing trials each for 7 days' worth of products. They will be exposed to 4 conditions with all cigarettes increasing in price and repeat the same conditions with all e-liquids increasing in price across trials. A balanced Latin square design will be used to present the following conditions: In the Cigarette Flavor Restricted, only conventional tobacco cigarettes will be available. In the Cigarette Flavor Unrestricted, tobacco and menthol cigarettes will be available. In the E-Cigarette Flavor Restricted, only tobacco flavor e-liquids will be available. In the E- Cigarette Flavor Unrestricted, tobacco flavor e-liquid and a variety of other flavors will be available from five broad categories: tobacco, fruit, dessert, menthol, and coffee. A range of other tobacco products will be available across conditions, such as snus, lozenge, gums, dip, and nicotine pouch. 3\) In the follow-up session, participants will be able to return the e-cigarette if they wish. They will answer Perceived Health Risk assessments, complete hypothetical purchase tasks for cigarettes and e-cigarettes, rank order the products they sampled, and complete a liking scale for every tobacco product. We will summarize demographic characteristics (e.g., age, race, income) and smoking-related measures (e.g., FTCD, QSU, PHR) using means, standard deviations, and percentages. For each product category in the ETM, we will test whether policy restrictions differentially influence purchasing of cigarettes, e-cigarettes, oral tobacco/nicotine products, and NRT products. We will use hierarchical linear regression to evaluate differences in purchasing behavior, including a three-way interaction among the cigarette policy condition, the e-cigarette policy condition, and the log-transformed manipulated commodity price, with random intercepts for individuals. Model selection will be performed to identify the best-supported combination of predictors and interaction terms. We will conduct an exhaustive model search and select the optimal model based on the lowest Bayesian Information Criterion (BIC). Model posterior probabilities will be calculated using BIC following Barbieri and Berger \[29\]. Model summary statistics will be reported using Type III sums of squares and Kenward-Roger degrees of freedom \[30\]. All analyses will be performed in R (Version 4.3.0) \[31\], and statistical significance will be defined as p \< 0.05. Additional analyses may be conducted.
Interventions
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.
Sponsors
Study design
Eligibility
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. 1. Minors, as defined by state law where the study is performed (infants, children, teenagers) 2. Pregnant women (can be included in minimal risk studies by mentioning in section 13.1) 3. Prisoners (including all incarcerated individuals) 4. Adults not capable to consent on their own behalf
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine/Tobacco Products Substitution | During the intervention, session 2 (1 day per participant) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Menthol Cigarette Smokers 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.
Manipulation of nicotine/tobacco product price and availability: 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Menthol Cigarette Smokers |
|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 12.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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).
Time frame: During the intervention, session 2 (1 day per participant)
Population: All participants who completed at least one of the experimental purchase scenarios. Missing data for participants who did not complete a condition are noted in the outcome data table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; Cig price increased; product: Cigarette | 1326.25 mg of nicotine purchased | Standard Error 290.72 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; Cig price increased; product: E-Liquid | 206 mg of nicotine purchased | Standard Error 57.29 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; Cig price increased; product: NRT | 120.83 mg of nicotine purchased | Standard Error 39.18 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; Cig price increased; product: OTNP | 46.79 mg of nicotine purchased | Standard Error 26.2 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; Cig price increased; product: Cigarette | 2177.2 mg of nicotine purchased | Standard Error 330.38 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; Cig price increased; product: E-Liquid | 528 mg of nicotine purchased | Standard Error 150.78 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; Cig price increased; product: NRT | 41.28 mg of nicotine purchased | Standard Error 16.49 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; Cig price increased; product: OTNP | 20.72 mg of nicotine purchased | Standard Error 12.57 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: Cigarette | 1373.2 mg of nicotine purchased | Standard Error 316.93 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: E-Liquid | 921.6 mg of nicotine purchased | Standard Error 277.03 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: NRT | 74.72 mg of nicotine purchased | Standard Error 28.75 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: OTNP | 16.16 mg of nicotine purchased | Standard Error 7.55 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: Cigarette | 2182 mg of nicotine purchased | Standard Error 307.2 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: E-Liquid | 126.72 mg of nicotine purchased | Standard Error 40.22 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: NRT | 96.8 mg of nicotine purchased | Standard Error 48.93 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: OTNP | 19.08 mg of nicotine purchased | Standard Error 9.34 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; E-cig price increased; product: Cigarette | 1590 mg of nicotine purchased | Standard Error 332.35 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; E-cig price increased; product: E-Liquid | 164.16 mg of nicotine purchased | Standard Error 44.74 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; E-cig price increased; product: NRT | 121.44 mg of nicotine purchased | Standard Error 53.82 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors restricted; E-cig price increased; product: OTNP | 50.76 mg of nicotine purchased | Standard Error 35.23 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; E-cig price increased; product: Cigarette | 2674.58 mg of nicotine purchased | Standard Error 503.29 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; E-cig price increased; product: E-Liquid | 327 mg of nicotine purchased | Standard Error 103.98 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; E-cig price increased; product: NRT | 37.17 mg of nicotine purchased | Standard Error 16.01 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig & E-cig flavors unrestricted; E-cig price increased; product: OTNP | 9.33 mg of nicotine purchased | Standard Error 5.16 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: Cigarette | 1774.17 mg of nicotine purchased | Standard Error 425.03 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: E-Liquid | 821 mg of nicotine purchased | Standard Error 248.81 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: NRT | 58 mg of nicotine purchased | Standard Error 24.64 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: OTNP | 14.21 mg of nicotine purchased | Standard Error 7.53 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: Cigarette | 3312.92 mg of nicotine purchased | Standard Error 491.67 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: E-Liquid | 116 mg of nicotine purchased | Standard Error 37.08 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: NRT | 62.33 mg of nicotine purchased | Standard Error 22.86 |
| Menthol Cigarette Smokers | Nicotine/Tobacco Products Substitution | Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: OTNP | 13.42 mg of nicotine purchased | Standard Error 7.39 |