The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Menthol Flavor Electronic Cigarette

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

Group Type ACTIVE_COMPARATOR

Menthol-flavored electronic cigarette

Intervention Type OTHER

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 Flavor Electronic Cigarette

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

Group Type ACTIVE_COMPARATOR

Tobacco-flavored electronic cigarette

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes