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

NCT03402243 | Completed Results

• 1 other identifier: R03DA045150
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• Amount of Tobacco Product Used

  Total number of cigarettes smoked and puffs of e-cigarettes used

  6 weeks

Secondary Outcomes (2)

• How Much of Each Product is Obtained From the "Experimental Marketplace"

  6 weeks

• Motivation to Quit Smoking Cigarettes

  6 weeks

Study Arms (3)

Menthol ban only for cigarettes

EXPERIMENTAL

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

Menthol ban for cigarettes and e-cigarettes

EXPERIMENTAL

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

No Menthol Ban

OTHER

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

Interventions

Menthol ban on cigarettes OTHER

Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes

Menthol ban only for cigarettes

Menthol ban on cigarettes and e-cigarettes OTHER

Participants will have neither menthol flavored cigarettes or e-cigarettes available

Menthol ban for cigarettes and e-cigarettes

No menthol ban OTHER

Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available

No Menthol Ban

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 35430631 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Michael Kotlyar
• Organization: University of Minnesota

kotly001@umn.edu

612-625-1160

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 18, 2018
• Study Start: February 26, 2018
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)