Recruiting

Menthol Flavoring

Sponsor:

Rosalind Franklin University of Medicine and Science

Code:

NCT06232447

Conditions

Cigarette Smoking

Inflammatory Response

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Cigarette Type Switching

Study Details

Brief summary:

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.

Conditions

Cigarette Smoking

Inflammatory Response

Study ID

NCT06232447

Start date

Mar 26, 2024

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

68 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cigarette Type Switching

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

Interventions

Cigarette Type Switching

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

Primary outcome measure

  • high sensitivity C-reactive protein [ Time Frame: 4 weeks ]
  • Fibrinogen [ Time Frame: 4 weeks ]
  • Cytokine Panel 13 [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Nancy C Jao, PhD

847-578-8747nancy.jao@rosalindfranklin.edu

Locations

Rosalind Franklin University of Medicine and Science

Recruiting

North Chicago, Illinois, United States, 60064

Contacts

Nancy C Jao, PhD

847-578-8747nancy.jao@rosalindfranklin.edu

More Information

Sponsor

Rosalind Franklin University of Medicine and Science

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rosalind Franklin University of Medicine and Science on 2026-04-16.