An Experimental Evaluation of Menthol-Flavored Tobacco Accessories

Not Applicable

Not yet recruiting

• Conditions: Cigarette; Cigarette Smoking Behavior; Smoking Behaviors

• Registration Number: NCT07092501
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

In a within-subjects design in-laboratory study, participants will sample non-menthol cigarettes mentholated with various accessories (e.g., crush balls, filter tips, aroma cards) in a controlled setting. They will compare these to their preferred menthol brand using subjective ratings (e.g., liking, strength, ease of use) and complete purchase tasks and ETM trials to assess product demand and likelihood of future use.

Detailed Description

Cigarette smoking remains the leading preventable cause of death and disease in the United States (US), accounting for half a million deaths per year and nearly 30% of all cancer deaths. More than 28 million US adults smoke daily, 35% of whom smoke menthol flavored cigarettes. Menthol cigarettes are linked to increased risk of smoking initiation and reduced likelihood of cessation. In addition to increased product appeal and attractiveness, menthol's cooling properties may induce misperceptions of reduced harm and mask early symptoms of respiratory disease. A cohort study (N ≈ 1 million) by the American Cancer Society found that former menthol smokers had a 12-43% higher risk of all-cause and heart disease mortality compared to former non-menthol smokers.

Efforts to reduce the appeal of cigarettes have been enacted worldwide, with several countries adopting regulatory policies on menthol flavor in tobacco products. In the US, state and local governments have been leading these tobacco control efforts, with over 140 localities implementing a menthol cigarette ban as of December 2024, including California and Massachusetts. Menthol bans have been effective in reducing smoking prevalence and increasing cessation rates. Nonetheless, at least one-third of menthol smokers continue to smoke after a menthol ban. A key contributor is the tobacco industry's promotion of mentholation accessories - including crush balls, filter tips, aroma cards - that consumers can use to flavor non-menthol cigarettes after purchase. These accessories, often nicotine-free and sold separately from tobacco products, fall outside the scope of tobacco regulations and have grown in popularity in jurisdictions with bans. Studies indicate that up to 40% of pre-ban menthol smokers may adopt these accessories after restrictions take effect, undermining public health objectives.

In this study, the investigators will experimentally examine subjective ratings of non-menthol cigarettes, flavored with various menthol-flavor accessories (e.g., crush balls, filter tips, aroma cards), compared to participants' own preferred brand of menthol cigarettes and non-menthol cigarettes equivalent.

In a within-subject design, menthol cigarette smokers will sample non-menthol cigarettes mentholated with menthol-flavor accessories (e.g., crush balls, filter tips, aroma cards), non-menthol cigarettes and their own cigarettes. Participants will provide subjective ratings of each product (e.g., liking, strengh, ease of use) in comparison to their usual menthol cigarette brand. They will complete hypothetical cross-commodity purchase tasks and will complete one control trial and two ETM conditions representing different levels of restriction on menthol flavor in cigarettes. Within each condition, the investigators will manipulate availability of products and observe purchasing patterns across tobacco products and menthol-flavored accessories.

The study will consist of one in-lab visit. The study phases include: 1) Screening Phase; 2) Consent and assessments; 3) Sampling and subjective ratings assessments, and 4) ETM and hypothetical purchasing trials.

1. Screening phase Recruited participants will be redirected to an online pre-screening platform (e.g., Ripple) to complete assessments related to tobacco and nicotine use, pregnancy status (if applicable), physical and medical conditions, use of smoking cessation medications, intentions to quit tobacco or nicotine products, and plans to relocate from the area. Individuals who meet the eligibility criteria will be invited to participate in the full research study. Participants will also report on cigarette brand preferences for preparation of the research cigarettes to be sampled.

1.1) Cigarette preparation: In this project, participants' preferred brand of cigarettes will be used for sampling. They will sample their preferred menthol cigarette, a non-menthol equivalent and the non-menthol equivalent flavored with two different types of menthol-flavored accessories. All external indicators of whether a cigarette is menthol or non-menthol will be carefully concealed to prevent participants from identifying the product type based on visual cues. Fisherbrand Labeling Tape (non-toxic, heat-resistent, 13mm wide; Fisher Scientific, Pittsburgh, PA) will be used to cover any identifying marks near the filter end, without obstructing the filter vent holes. If markings are present along the tobacco rod, they will be further masked using top-brand cigarette papers. This procedure ensures that participants are blind to the menthol status of the cigarette, maintaining the integrity of experimental conditions.

2. Consent and Assessments (approximately 1 hour) In the consent and initial assessment session, participants will go through standard consent procedures. Participants will provide a breath sample to confirm recent levels of smoking that will be measured using a CoVita® Micro+ Basic Smokelizer. Participants of childbearing potential will be asked to provide a urine sample for pregnancy testing. Those with a positive pregnancy result will be excluded from the study. Participants will complete a timeline follow back to assess the previous month's smoking habits and consumption of nicotine products to determine ETM budget. Participants will complete a survey with demographic questions and nicotine/tobacco-related assessments (Fagerstrom Test for Cigarette Dependence, Perceived Health Risk adapted, Questionnaire on Smoking Urges-Brief, Motivation to Quit, Self-efficacy to Quit, and The Contemplation Ladder adapted).

3. Sampling and subjective ratings assessments (approximately 2:30 hours) . Participants will participate in five sampling trials (menthol cigarette, non-menthol cigarette, non-menthol cigarette mentholated with accessory 1, with accessory 2, and with accessory 3). They will be exposed to these trials in a randomized order. In each trial, participants will take four guided puffs from one cigarette. They will have a 20-minute washout period between trials. They will first complete subjective ratings for the product they just sampled. Then, during the washout period, participants will be instructed to rinse their mouth thoroughly with room-temperature water three times. Each rinse will last approximately 10 seconds, and participants will be guided to swish the water around all areas of the mouth before expectorating. A one-minute rest will follow each rinse to allow residual taste to dissipate. No food or drink will be allowed during this period.

4. ETM and hypothetical purchasing trials (approximately 30 minutes).

In the ETM session, participants will be provided with an individual 7-day experimental budget calculated based on their average tobacco/nicotine consumption over the past 7 days. For example, if a participant reports smoking 20 cigarettes per day (a pack), they will receive $70.00, equivalent to 140 cigarettes (or 7 packs) multiplied by $0.50 per cigarette (market price of an individual cigarette) to spend in the ETM. In the ETM, first, participants will experience two practice trials. Then, participants will complete the real ETM consisting of one control trial and two menthol flavor restrictions (menthol cigarettes unavailable and both menthol cigarettes and menthol-flavored accessories unavailable). Participants will complete a total of 3 purchasing trials each for 7 days worth of products. In each trial, participants will buy tobacco products to use throughout the next 7 days. At the end of the session, the participant will randomly draw an individual purchasing trial and will receive all the products purchased at that trial to use over the next week. During the following 7 days, the participant is asked to use only the tobacco/nicotine products received during the study.

The investigators will use repeated-measures analysis of variance (ANOVA) to assess differences in subjective ratings (e.g., liking, strength, ease of use) and purchasing behavior across the five product types. Main effects and planned comparisons will be tested to determine whether menthol accessories significantly alter product perceptions or demand compared to non-menthol cigarettes and usual menthol brands.

Purchasing behavior from the ETM trials and hypothetical purchase tasks will be analyzed using generalized linear mixed models (GLMMs) to account for repeated observations within individuals and the categorical nature of product selections. Demand metrics (e.g., breakpoint, elasticity, intensity) will be derived from purchase task data using established demand curve modeling procedures.

Exploratory analyses will examine the moderating effects of demographic variables (e.g., age, gender, race/ethnicity) and baseline smoking behavior (e.g., cigarettes per day, brand preference) on product perceptions and purchasing patterns. All analyses will be conducted using R, with significance set at p \< .05 and adjustments made for multiple comparisons where applicable.

Additional analysis may be conducted.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study Start: 2025-07-23
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute Subjective Ratings	Day 1	Participants will provide the subjective ratings (e.g. liking, strengh, ease of use) of each product in comparison to their usual menthol cigarette brand.

Secondary Outcome Measures

Name	Time	Method
Own-price and cross-price demand indices	Day 1	Participants will complete purchasing trials in a hypothetical purchase task and the Experimental Tobacco Marketplace (ETM) which is a virtual store designed to mimic real-world shopping environments. In the hypothetical purchase task, participants will complete multiple trials where the price of a product will increase progressively. In the ETM participants will complete purchasing trials simulating different policy scenarious.

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC; 🇺🇸 Roanoke, Virginia, United States