Health TrialsbyHealthPanel

Menthol, Inflammation, and Nicotine Transition Study

ConditionsCigarette SmokingInflammatory Response
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorRosalind Franklin University of Medicine and Science

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cigarette Type Switching

    Other intervention

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

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: Cigarette Type SwitchingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

high sensitivity C-reactive protein

from serum in mg/dL

Time frame
4 weeks
2

Fibrinogen

from serum in mg/dL

Time frame
4 weeks
3

Cytokine Panel 13

from serum in mg/dL

Time frame
4 weeks

Secondary outcomes

1

Blood pressure

systolic blood pressure and diastolic blood pressure, in mm Hg

Time frame
4 weeks
2

Heart rate

beats per minute

Time frame
4 weeks

Other outcomes

1

Affect

Positive and Negative Affect Scale (PANAS)

Time frame
4 weeks
2

Urge to smoke

Questionnaire on Smoking Urges-Brief (QSU)

Time frame
4 weeks
3

Nicotine Dependence

Fagerström Test for Cigarette Dependence (FTCD)

Time frame
4 weeks
4

Number of cigarettes smoked

Self-reported total number of menthol and non-menthol cigarettes smoked per day

Time frame
4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rosalind Franklin University of Medicine and Science

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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