Sympathomimetic 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/Actively Recruiting
Led by Wake Forest University Health Sciences · Updated on 2025-10-03
49
Participants Needed
1
Research Sites
N/A
Total Duration
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
Cardiovascular Effects of Very Low Nicotine Content Cigarettes
M
Maria Anwar, MS
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Wake Forest University Health Sciences
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | VLNC SPECTRUM Cigarettes | Usual Brand Cigarettes |
|---|---|---|
| What it is | Cigarettes manufactured with very low nicotine content (VLNC) provided as research cigarettes (SPECTRUM), used to examine acute cardiovascular effects in adult smokers. | Conventional commercial cigarettes with standard nicotine content commonly smoked by adults, representing the usual product used by the trial population. |
| Role in Trial | This is the experimental product in the study, tested to measure acute effects on heart rate, heart rate variability, and ECG within regular smokers. | Serves as a clinical comparator, representing the product typically used by the eligible population outside a research setting. |
| Primary use | Designed for research into acute cardiac and vascular responses to significantly reduced nicotine exposure in people who smoke. | Widely used for tobacco consumption, providing typical nicotine exposure; used in research to establish usual cardiovascular response for this population. |
| How it is given or performed | Participants smoke SPECTRUM research cigarettes with very low nicotine in a controlled research setting; specific protocols control timing and measurement windows. | Participants smoke their own brand of commercial cigarettes as they would typically, with acute cardiovascular measurements taken afterwards. |
| External evidence status | Published studies show that cigarettes with reduced nicotine content can lower overall nicotine intake and reduce exposure to tobacco toxins, with acute cardiovascular responses studied but long-term outcome evidence still accumulating. | Well-documented to increase heart rate, blood pressure, and trigger acute cardiovascular changes with every cigarette smoked. |
| Important limitations | This research is limited to controlled, short-term outcomes in adult smokers; it cannot address longer-term cardiovascular risks or real-world use patterns. | Although substantial evidence documents acute cardiovascular effects, this column does not capture long-term changes or differences in product additives and smoke composition. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Lead Sponsor