An Experimental Evaluation of Menthol-Flavored Tobacco Accessories

NCT07092501 | Active Not Recruiting

• 1 other identifier: VT IRB # 25-695
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette; Smoking Behaviors; Cigarette Smoking Behavior

Keywords

Menthol Cigarettes; Subjective Ratings; Experimental Tobacco Marketplace; Menthol Accessories

Outcome Measures

Primary Outcomes (1)

• Modified Cigarette Evaluation Questionnaire (mCEQ)

  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.

  Day 1

Secondary Outcomes (5)

• Own-price and cross-price demand intensity (q0)

  Day 1

• Own-price and cross-price demand elasticity (alpha)

  Day 1

• Own-price and cross-price demand breakpoint

  Day 1

• Own-price and cross-price demand Pmax

  Day 1

• Experimental Tobacco Marketplace purchase patterns

  Day 1

Study Arms (1)

Menthol cigarette smokers

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.

Behavioral: Mentholated cigarette sampling; Behavioral: Hypothetical Policy Scenarios; Behavioral: Subjective value assessment

Interventions

Mentholated cigarette sampling BEHAVIORAL

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.

Menthol cigarette smokers

Hypothetical Policy Scenarios BEHAVIORAL

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.

Menthol cigarette smokers

Subjective value assessment BEHAVIORAL

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

Menthol cigarette smokers

Eligibility Criteria

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

You may qualify if:

• 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)
• Smoke at least 10 cigarettes daily
• Use other tobacco products less than weekly

You may not qualify if:

• 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
• Have plans to move out of the area during the experiment

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Related Publications (6)

• Pickworth WB, Moolchan ET, Berlin I, Murty R. Sensory and physiologic effects of menthol and non-menthol cigarettes with differing nicotine delivery. Pharmacol Biochem Behav. 2002 Jan-Feb;71(1-2):55-61. doi: 10.1016/s0091-3057(01)00623-2.

  PMID: 11812507 BACKGROUND

• Kyriakos CN, Driezen P, Fong GT, Chung-Hall J, Hyland A, Geboers C, Craig LV, Willemsen MC, Filippidis FT. Illicit purchasing and use of flavour accessories after the European Union menthol cigarette ban: findings from the 2020-21 ITC Netherlands Surveys. Eur J Public Health. 2023 Aug 1;33(4):619-626. doi: 10.1093/eurpub/ckad049.

  PMID: 37527828 BACKGROUND

• Erinoso O, Clegg Smith K, Iacobelli M, Saraf S, Welding K, Cohen JE. Global review of tobacco product flavour policies. Tob Control. 2020 May 15;30(4):373-9. doi: 10.1136/tobaccocontrol-2019-055454. Online ahead of print.

  PMID: 32414867 BACKGROUND

• Bandi P, Newton C, Xue Z, Thomson B, Asare S, Patel M, Islami F, Nargis N, Patel AV, Jemal A, Westmaas JL, Diver WR. Association of menthol-flavoured cigarette smoking with all-cause and cause-specific mortality risk. Tob Control. 2025 Feb 13:tc-2024-059020. doi: 10.1136/tc-2024-059020. Online ahead of print.

  PMID: 39947700 BACKGROUND

• Lortet-Tieulent J, Goding Sauer A, Siegel RL, Miller KD, Islami F, Fedewa SA, Jacobs EJ, Jemal A. State-Level Cancer Mortality Attributable to Cigarette Smoking in the United States. JAMA Intern Med. 2016 Dec 1;176(12):1792-1798. doi: 10.1001/jamainternmed.2016.6530.

  PMID: 27775761 BACKGROUND

• Havermans A, Pauwels CGGM, Bakker-'t Hart IME, Fayokun R, van Nierop LE, Hellmich IM, Talhout R. Across the world availability of flavour accessories for tobacco products. Tob Control. 2025 Jul 31;34(4):532-538. doi: 10.1136/tc-2023-058255.

  PMID: 38580443 BACKGROUND

MeSH Terms

Conditions

Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Roberta Freitas-Lemos, Ph.D.

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: September 1, 2025
• Primary Completion: December 20, 2025
• Study Completion: April 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-07

Locations

US (1)