Experimental Tobacco Marketplace in Regulating Flavored Tobacco Products in Menthol Cigarette Smokers

Not Applicable

Terminated

• Conditions: Cigarette Smoking
• Interventions: Behavioral: Smoking Cessation Intervention; Other: Functional Assessment; Other: Questionnaire Administration

• Registration Number: NCT03897530
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This trial uses an Experimental Tobacco Marketplace to study the purchase of tobacco products in menthol cigarette smokers. Determining the level of substitutability of both flavored and unflavored/tobacco flavored e-cigarettes when menthol cigarettes are available and unavailable can help determine if a flavor ban (of either menthol cigarettes and/or flavored e-cigarettes) will lead to smoking cessation and/or harm reduction. A greater understanding of tobacco product purchasing could help inform possible regulatory actions by the Food and Drug Administration.

Detailed Description

Participants view and purchase hypothetical tobacco products during four distinctly different Experimental Tobacco Marketplace (ETM) conditions. During the session, participants are presented with these randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

Study Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Study Start: 2019-06-30
• Primary Completion: 2023-07-20
• Study Completion: 2023-07-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Menthol cigarette smokers who report smoking a brand that has a non-menthol equivalent.
• Residing in Western New York.
• Voluntarily provide informed consent to participate in the study.

Exclusion Criteria

• Any known history of macular degeneration, glaucoma, cataracts, eye implant, permanently dilated pupils or the use of a screen reader/magnifier.

• The following special populations will not be included:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention	Smoking Cessation Intervention	During the session, participants are presented with randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.
Prevention	Functional Assessment	During the session, participants are presented with randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.
Prevention	Questionnaire Administration	During the session, participants are presented with randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

Primary Outcome Measures

Name	Time	Method
Eye tracking metrics	At the time of the session , assessed up to 15 months	the interaction of type of cigarette available (menthol versus non-menthol) and type of e-cigarette available (flavors versus unflavored and tobacco), will employ a 2 X 2 repeated measures ANOVA with post-hoc Bonferroni tests to evaluate the outcomes of Q0 (derived initial consumption without cost constraints), α (demand elasticity), the substitution levels, and the eye-tracking metrics.
Cessation of Menthol flavored cigarettes	At the time of the session , assessed up to 15 months	Number of flavored cigarettes purchased inThe Experimental Market Place (ETM) will be used to track tobacco purchase behaviors

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States