Establishing a nicotine threshold for addiction. The implications for tobacco regulation.
N L Benowitz, J E Henningfield
https://pubmed.ncbi.nlm.nih.gov/7818638Actively Recruiting
Early Phase 1
Age: 21Years +
All Genders
Healthy Volunteers
ID05707871
Cardiovascular Effects of Very Low Nicotine Content Cigarettes Compared to Normal Nicotine Cigarettes
Led by Wake Forest University Health Sciences · Updated on 2025-10-03
49
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Age: 21Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Self-reported cigarette smoking at least once in the past 30 days
- 21 years old or older
- Willingness to smoke research cigarettes or usual brand cigarettes during lab visit
- Ability to speak, comprehend, and read English sufficiently to complete study procedures
You will not qualify if you...
- Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism, or blood clots in legs or arm in the past 3 months
- Body temperature equal to or above 100.4°F
- Unstable health conditions interfering with electrocardiogram (ECG) measurements
- Self-reported diagnosis of hyperthyroidism or thyrotoxicosis
- Currently pregnant or breastfeeding
- Currently seeking treatment to quit smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 day
Participants smoke two very low nicotine content cigarettes and one normal nicotine content cigarette while their heart rate, heart rate variability, and electrocardiogram (ECG) are recorded.
1 in-person visit with smoking and ECG recording
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
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Research Team
M
Maria Anwar, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Published Research Related To This Trial
Reducing the nicotine content to make cigarettes less addictive.
Neal L Benowitz, Jack E Henningfield
https://pubmed.ncbi.nlm.nih.gov/23591498Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation.
Dorothy K Hatsukami, Michael Kotlyar, Louise A Hertsgaard...
https://pubmed.ncbi.nlm.nih.gov/20078491Hemodynamic effects of smoking cigarettes of high and low nicotine content.
L Tachmes, R J Fernandez, M A Sackner
https://pubmed.ncbi.nlm.nih.gov/688779Sympathomimetic Effects of Acute E-Cigarette Use: Role of Nicotine and Non-Nicotine Constituents.
Roya S Moheimani, May Bhetraratana, Kacey M Peters...
https://pubmed.ncbi.nlm.nih.gov/28931527