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Early Phase 1
Age: 21Years +
All Genders
Healthy Volunteers
ID05707871

Study of Heart and Circulation Effects from Very Low Nicotine and Regular Cigarettes

Led by Wake Forest University Health Sciences · Updated on 2025-10-03

49

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the cardiovascular effects of very low nicotine content cigarettes VLNCC compared to normal nicotine cigarettes in daily and non-daily smokers aged 21 and older. This early phase study aims to understand how reduced nicotine in cigarettes impacts heart rate, autonomic functions, and heart electrical activity, which is important as the FDA plans to regulate nicotine levels to reduce cigarette addictiveness. Participants will smoke 2 to 3 cigarettes of their usual brand and 1 to 2 SPECTRUM research cigarettes with varying nicotine content. During these sessions, electrocardiogram ECG recordings will be taken to measure changes in heart rate, heart rate variability, and ventricular repolarization indices. The study is non-randomized and single-masked. Throughout the study visit, participants will be monitored continuously with ECG to assess heart function changes within one hour after smoking each cigarette type. The main outcomes measured include heart rate changes for different nicotine levels and secondary measures such as heart rate variability and other ECG parameters. Participation involves smoking under controlled conditions and undergoing heart monitoring to evaluate cardiovascular responses to different nicotine levels.

CONDITIONS

Brief Title

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Research Team

M

Maria Anwar, MS

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