Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

Tobacco Use Disorder Clinical Trial

Official title:

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402243
• Other study ID #: R03DA045150
• Secondary ID: R03DA045150
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: March 25, 2020

Study information

• Verified date: July 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Be between the ages of 18 and 64

• Purchase exclusively menthol cigarettes

• Not currently motivated to quit smoking

• Smoking a minimum number of cigarettes per day

Exclusion Criteria:

• Report a serious, unstable medical or psychiatric condition

• Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)

• Have used any smoking cessation therapy during the past month

• Regularly use any form of tobacco other than cigarettes

• Are pregnant or breast feeding or planning to become pregnant or breast feed during the study

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Menthol ban on cigarettes
Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
• Menthol ban on cigarettes and e-cigarettes
Participants will have neither menthol flavored cigarettes or e-cigarettes available
• No menthol ban
Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available

Locations

Country	Name	City	State
United States	Clinical and Translational Sciences Institute	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Tobacco Product Used	Total number of cigarettes smoked and puffs of e-cigarettes used	6 weeks
Secondary	How Much of Each Product is Obtained From the "Experimental Marketplace"	Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"	6 weeks
Secondary	Motivation to Quit Smoking Cigarettes	Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time	6 weeks