NCT05707871EARLY_PHASE1RecruitingAccepts Healthy Volunteers

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Wake Forest University Health Sciences

Start Date

4/4/2023

Completion Date

12/1/2026

Summary

The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers

Detailed Description

The FDA is planning regulatory actions to limit nicotine levels in cigarettes as far as it is not reduced to zero. The strategy is designed to reduce the addictiveness of cigarettes. However, nicotine related effects of the cigarettes with reduced nicotine content on various body systems are largely unknown. Following formal implementation of the regulatory policy what cardiovascular effects of reduced nicotine cigarettes, also called very low nicotine content cigarettes (VLNCC) are expected to persist is important to determine. This study will determine the cardiovascular effects of VLNCC such as change in heart rate, autonomic functions and indices of ventricular repolarization in smokers. Participants will be asked to smoke two VLNCC and one normal nicotine content cigarette (NNCC) while we will be recording their electrocardiogram (ECG) to see a change in heart rate, heart rate variability and indices of ventricular repolarization.

Eligibility Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: * Self-reported cigarette smoking at least once in the past 30 days * ≥21 years old * Willingness to smoke research cigarettes or usual brand cigarettes during lab visit. * Ability to speak, comprehend, and read English sufficiently to complete study procedures Exclusion Criteria: * Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism \& blood clots in legs and arm in the past 3 months * Body temperature ≥ 100.4˙F * Unstable health conditions interfering with electrocardiogram (ECG) measurements * Self-reported diagnosis of hyperthyroidism or thyrotoxicosis * Currently pregnant (as indicated by urine pregnancy test at the start of laboratory visit) or breastfeeding. * Currently seeking treatment to quit smoking

Interventions

DRUG

SPECTRUM cigarettes

OTHER

usual brand of Cigarettes

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Conditions

Tobacco Use

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States