Effects of very low nicotine cigarettes on heart health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the cardiovascular effects of very low nicotine content cigarettes (VLNCC) on both daily and non-daily smokers. Participants will smoke two VLNCC and one normal nicotine content cigarette while their electrocardiograms (ECG) are recorded to assess changes in heart rate, heart rate variability, and indices of ventricular repolarization. The research aims to understand how reduced nicotine levels in cigarettes impact cardiovascular health, particularly in light of potential FDA regulations. The findings could provide critical insights into the safety and health implications of VLNCC.

Why it matters

Who can join: the full rules

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

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Eric C Donny, PhD — Wake Forest University Health Sciences
• Study coordinator: Maria Anwar, MS
• Email: manwar@wakehealth.edu
• Phone: 802-922-3343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.