The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Smoking Reduction Clinical Trial

Official title:

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555069
• Other study ID #: STUDY00148382
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Tricia Snow
• Phone: 816-398-8960
• Email: psnow[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.

Description:

Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes at week 12.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: November 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• = 21 years of age

• Smoke = 5 cigarettes per day (CPD)

• Smoke menthol cigarettes for = 6 months

• Verified smoker (CO >5ppm)

• Functioning telephone

• Interested in switching to E-cigarettes

Exclusion Criteria:

• Interested in quitting smoking

• Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes)

• E-cigarette use on = 4 of the past 30 days

• Uncontrolled hypertension: BP = 180(systolic) or = 105 (diastolic)

• Use of smoking cessation pharmacotherapy in the month prior to enrollment

• Pregnant, contemplating getting pregnant, or breastfeeding

• Plans to move from Kansas City during the treatment and follow-up phase

• Another household member enrolled in the study

Related Conditions & MeSH terms

• Smoking Reduction

Intervention

Other:
• Menthol-flavored electronic cigarette
Participants will receive 12 weeks of menthol -flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.
• Tobacco-flavored electronic cigarette
Participants will receive 12 weeks of tobacco-flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Nikki Nollen, PhD, MA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who switch from cigarettes to electronic cigarettes at Week 12	Complete switching is defined as exclusive use of e-cigarettes, confirmed with CO< 6ppm and predominant switching; defined as use of the e-cigarette with >50% reduction in CPD. This will compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching at Week 12.	Week 12
Secondary	Assessment of respiratory symptoms using spirometry	Spirometry summarizing forced expiratory flow (FEF) 25-75% and the American Thoracic Society Questionnaire will assess will assess acute respiratory symptoms experienced by cigarette and electronic cigarette smokers. This will help assess the tobacco harm reduction of electronic cigarettes.	Week 12
Secondary	Amount of e-liquid consumed	E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes.	Week 12