The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Sponsor

Nikki Nollen, PhD, MA (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05555069

Collaborator

(none)

800

Enrollment

Arms

37.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Reduction	Other: Menthol-flavored electronic cigarette Other: Tobacco-flavored electronic cigarette	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Anticipated Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Menthol Flavor Electronic Cigarette 400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.	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.
Active Comparator: Tobacco Flavor Electronic Cigarette 400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.	Other: 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.

Arm

Intervention/Treatment

Active Comparator: Menthol Flavor Electronic Cigarette

400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.

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.

Active Comparator: Tobacco Flavor Electronic Cigarette

400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.

Other: 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.

Outcome Measures

Primary Outcome Measures

Number of participants who switch from cigarettes to electronic cigarettes at Week 12 [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.

Secondary Outcome Measures

Assessment of respiratory symptoms using spirometry [Week 12]
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.
Amount of e-liquid consumed [Week 12]
E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nikki Nollen, PhD, MA

Investigators

Principal Investigator: Nicole Nollen, PhD, University of Kanas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nikki Nollen, PhD, MA, Professor, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT05555069

Other Study ID Numbers:

STUDY00148382

First Posted:

Sep 26, 2022

Last Update Posted:

Sep 26, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Menthol

Study Results

No Results Posted as of Sep 26, 2022