Menthol, Inflammation, and Nicotine Transition Study

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2026-06-30

Brief Summary

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This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.

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Detailed Description

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The goal of this study is to examine how switching from menthol (MC) to non-menthol (NMC) cigarette smoking may impact biomarkers of systemic inflammation, smoking behavior, and subjective responses related to smoking. MC smokers (N=68) will be recruited for a five-week study, with one-week of baseline of MC smoking (Phase 1), followed by four weeks of switching to study-provided, brand-matched NMCs (Phase 2). Biomarkers of systemic inflammation and tobacco exposure will be analyzed from blood samples before, during, and after switching for four weeks (baseline, week 1, week 3, and week 5). Ecological momentary assessment methods will also be gathered to measure patterns of smoking and smoking-related subjective responses (affect, craving).

Conditions

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Cigarette Smoking Inflammatory Response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cigarette Type Switching

Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes

Group Type EXPERIMENTAL

Cigarette Type Switching

Intervention Type OTHER

Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks

Interventions

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Cigarette Type Switching

Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women between 21-85 years old
* Currently uses menthol cigarettes
* Daily smoking rate of ≥5 cigarettes/day for ≥1 year
* Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application
* Able to read and communicate fluently in English

Exclusion Criteria

* Currently pregnant or breastfeeding
* Actively trying to quit smoking
* Current heavy alcohol use
* Frequent use of non-menthol cigarettes, other smoking products, or illicit substances
* History of severe medical/psychiatric condition or treatment

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes