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

Cigarette Smoking Clinical Trial

Official title:

Flavored Tobacco Product Regulation: Behavioral Economic Demand, Visual Attention, and Flavored Tobacco Product Availability

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03897530
• Other study ID #: I 75418
• Secondary ID: R03CA228930
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: July 20, 2023

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Smoking Cessation Intervention
View and purchase hypothetical tobacco products during four distinctly different ETM

Other:
• Functional Assessment
Visual attention is evaluated via eye-tracking equipment
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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), a (demand elasticity), the substitution levels, and the eye-tracking metrics.	At the time of the session , assessed up to 15 months