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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: Menthol ban on cigarettes; Other: Menthol ban on cigarettes and e-cigarettes; Other: No menthol ban

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Clinical and Translational Sciences Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Menthol ban only for cigarettes; Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge	Other: Menthol ban on cigarettes; Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
EXPERIMENTAL: Menthol ban for cigarettes and e-cigarettes; Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge	Other: Menthol ban on cigarettes and e-cigarettes; Participants will have neither menthol flavored cigarettes or e-cigarettes available
OTHER: No Menthol Ban; Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge	Other: No menthol ban; Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Tobacco Product Used	Total number of cigarettes smoked and puffs of e-cigarettes used	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Hatsukami DK. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes. Nicotine Tob Res. 2022 Aug 6;24(9):1448-1457. doi: 10.1093/ntr/ntac107.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2018
• Primary Completion (ACTUAL): March 25, 2020
• Study Completion (ACTUAL): March 25, 2020

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (ACTUAL): January 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: R03DA045150 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No identifiable information will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No