Effects of very low nicotine cigarettes on heart health
Cardiovascular Effects of Very Low Nicotine Content Cigarettes
This study is testing how smoking very low nicotine cigarettes affects heart health in both daily and occasional smokers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05707871 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who smoke cigarettes at least once in the past 30 days.
Not a fit: Patients with recent cardiovascular diseases or unstable health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could inform regulatory policies and improve cardiovascular health outcomes for smokers.
How similar studies have performed: While studies on nicotine content and smoking have been conducted, the specific focus on cardiovascular effects of VLNCC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.