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Menthol Tobacco Accessories Trial for Subjective Effects and Purchasing Behavior

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Study AimThis study examines how menthol tobacco accessories affect users' opinions and purchasing behavior, inviting participants to rate products compared to their regular menthol cigarettes.
What is being tested

Mentholated cigarette sampling

+ Hypothetical Policy Scenarios
+ Subjective value assessment
Behavioral
Who is being recruted

Cigarette Smoking
+2

+ Tobacco Smoking
+ Behavior
Over 21 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorVirginia Polytechnic Institute and State University
Study ContactRoberta Freitas-Lemos, Ph.D.More contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual date on which the first participant was enrolled.

This study investigates how menthol-flavored accessories, like crush balls and filter tips, influence the perception and purchasing behavior of menthol cigarette smokers. Menthol cigarettes are popular but known for increasing the likelihood of smoking initiation and making quitting harder. With bans on menthol cigarettes in some areas, many smokers turn to these accessories to flavor regular cigarettes. This study aims to understand if these accessories change how smokers rate the cigarettes' appeal and if they affect purchasing choices, which could undermine public health efforts to reduce smoking. Participants in the study will sample both regular and menthol-flavored cigarettes using these accessories, as well as their usual menthol brand, during a controlled lab visit. They will rate their enjoyment and ease of use for each type. Participants will also engage in purchasing tasks, simulating different market conditions where menthol options are limited. Their choices and preferences will be analyzed to see if the accessories significantly alter perceptions or demand compared to non-menthol and usual menthol brands. This research could influence future tobacco regulations and strategies aimed at reducing smoking rates.

Official TitleAn Experimental Evaluation of Menthol-Flavored Tobacco Accessories: Subjective Effects and Purchasing Behavior 
NCT07092501
Principal SponsorVirginia Polytechnic Institute and State University
Study ContactRoberta Freitas-Lemos, Ph.D.More contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
23 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cigarette Smoking
Tobacco Smoking
Behavior
Smoking
Tobacco Use
Criteria
6 inclusion criteria required to participate
Provide informed consent
Be a menthol cigarette smoker
Be at least 21 years of age or older
Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)

Show More Criteria

5 exclusion criteria prevent from participating
Have uncontrolled physical or mental health conditions
Use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days
Report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days
If they are pregnant or lactating

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Menthol cigarette smokers will sample non-menthol cigarettes mentholated using menthol-flavored 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, strength, ease of use) in comparison to their usual menthol cigarette brand. They will complete hypothetical cross-commodity purchase tasks and ETM trials to assess product demand and likelihood of use in different conditions.

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.

Participants will complete the real Experimental Tobacco Marketplace 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.

Participants will complete a hypothetical purchase task where the price of a variety of products will increase progressively during the task.
Study Objectives
Primary Objectives

Participants will provide the subjective ratings (e.g. liking, strength, ease of use) of each product in comparison to their usual menthol cigarette brand. The scale ranges from not at all (1) to extremely (7). Four factor scoring comprising stimulant effects (sum of items 5, 7 and 8, range from 3 to 21), positive reinforcement (sum of items 2, 3 and 12, range from 3 to 21), negative reinforcement (sum of items 4, 6 and 11, range from 3 to 21) and aversion (sum of items 9 and 10, range from 2 to 14). High scores represents higher positive effects for the first 3 factor and higher negative effect for the last factor.
Secondary Objectives

Participants will complete purchasing trials in a hypothetical purchase task. In the hypothetical purchase task, participants will complete multiple trials where the price of a product will increase progressively. The availability of alternative products will be manipulated. We will measure demand intensity (q0) while product prices increase across trials.

Participants will complete purchasing trials in a hypothetical purchase task. In the hypothetical purchase task, participants will complete multiple trials where the price of a product will increase progressively. The availability of alternative products will be manipulated. We will measure demand elasticity (alpha) while product prices increase across trials.

Participants will complete purchasing trials in a hypothetical purchase task. In the hypothetical purchase task, participants will complete multiple trials where the price of a product will increase progressively. The availability of alternative products will be manipulated. We will measure demand brekapoint while product prices increase across trials.

Participants will complete purchasing trials in a hypothetical purchase task. In the hypothetical purchase task, participants will complete multiple trials where the price of a product will increase progressively. The availability of alternative products will be manipulated. We will measure demand Pmax while product prices increase across trials.

Participants will complete the Experimental Tobacco Marketplace (ETM) which is a virtual store designed to mimic real-world shopping environments. In the ETM participants will complete purchasing trials simulating different policy scenarios. We will measure quantity of products purchased per trial and number of individuals purchasing at least one product in each trial.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Fralin Biomedical Research Institute at VTCRoanoke, United StatesSee the location
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One Study Center
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