Menthol, Inflammation, and Nicotine Transition Study

NCT06232447 | Recruiting

• 2 other identifiers: CHP22-366K01HL164670
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• high sensitivity C-reactive protein

  from serum in mg/dL

  4 weeks

• Fibrinogen

  from serum in mg/dL

  4 weeks

• Cytokine Panel 13

  from serum in mg/dL

  4 weeks

Secondary Outcomes (2)

• Blood pressure

  4 weeks

• Heart rate

  4 weeks

Other Outcomes (5)

• Affect

  4 weeks

• Urge to smoke

  4 weeks

• Nicotine Dependence

  4 weeks

Study Arms (1)

Cigarette Type Switching

EXPERIMENTAL

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

Other: Cigarette Type Switching

Interventions

Cigarette Type Switching OTHER

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

Cigarette Type Switching

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, 60064, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Nancy C Jao, PhD

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy C Jao, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 30, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)