NCT03402243

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

Completed NA Results posted Last updated 10 August 2021

What this trial tests

NA trial testing Menthol ban on cigarettes in Tobacco Use Disorder in 47 participants. Completed in 25 March 2020.

Timeline

26 February 2018

Primary endpoint
25 March 2020

25 March 2020

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	47
Start date	26 February 2018
Primary completion	25 March 2020
Estimated completion	25 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Menthol ban on cigarettes
• Menthol ban on cigarettes and e-cigarettes
• No menthol ban

Conditions studied

• Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

University of Minnesota

Who can join

Adults 18 to 64, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Amount of Tobacco Product Used Primary · 6 weeks

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

Cigarettes smoked per day

Group	Value	95% CI
Menthol Ban Only for Cigarettes	13.1	± 5.5
Menthol Ban for Cigarettes and E-cigarettes	18.6	± 5.7
No Menthol Ban	15.3	± 5.0

Puffs of e-cigarettes used per day

Group	Value	95% CI
Menthol Ban Only for Cigarettes	56.7	± 180.2
Menthol Ban for Cigarettes and E-cigarettes	10.7	± 24.9
No Menthol Ban	4.5	± 8.6

How Much of Each Product is Obtained From the "Experimental Marketplace" Secondary · 6 weeks

Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"

Packs of cigarettes

Group	Value	95% CI
Menthol Ban Only for Cigarettes	22.6	± 10.38
Menthol Ban for Cigarettes and E-cigarettes	29.3	± 11.06
No Menthol Ban	28.8	± 10.7

Units of e-cigarette liquid

Group	Value	95% CI
Menthol Ban Only for Cigarettes	3.13	± 3.16
Menthol Ban for Cigarettes and E-cigarettes	1.2	± 1.57
No Menthol Ban	1.06	± 1.34

Motivation to Quit Smoking Cigarettes Secondary · 6 weeks

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

Group	Value	95% CI
Menthol Ban Only for Cigarettes	3.6	± 2.2
Menthol Ban for Cigarettes and E-cigarettes	3.1	± 2.2
No Menthol Ban	3.2	± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: For the duration of each participant's participation (up to 6 weeks for each participant). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Menthol Ban Only for Cigarettes

Serious: 0/16 (0%)

Deaths: 0/16

Menthol Ban for Cigarettes and E-cigarettes

Serious: 0/15 (0%)

Deaths: 0/15

No Menthol Ban

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (2 terms — click to expand)

Reaction	System	Menthol Ban Only for Cigar…	Menthol Ban for Cigarettes…	No Menthol Ban
throat irritation / cough	Respiratory, thoracic and mediastinal disorders	—	—	—
pain / discomfort during inhalation	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03402243 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes.
   Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, et al · · 2022 · cited 6× · PMID 35430631 · DOI 10.1093/ntr/ntac107