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

NCT03897530 | Terminated

• 2 other identifiers: I 75418R03CA228930
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Cessation of Menthol flavored cigarettes

  Number of flavored cigarettes purchased inThe Experimental Market Place (ETM) will be used to track tobacco purchase behaviors

  At the time of the session , assessed up to 15 months

• Eye tracking metrics

  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.

  At the time of the session , assessed up to 15 months

Study Arms (1)

Prevention

EXPERIMENTAL

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.

Behavioral: Smoking Cessation Intervention; Other: Functional Assessment; Other: Questionnaire Administration

Interventions

Smoking Cessation Intervention BEHAVIORAL

View and purchase hypothetical tobacco products during four distinctly different ETM

Prevention

Functional Assessment OTHER

Visual attention is evaluated via eye-tracking equipment

Prevention

Questionnaire Administration OTHER

Ancillary studies

Prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Amanda Quisenberry

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: June 30, 2019
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)