NCT05707871

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers

Detailed description

The FDA is planning regulatory actions to limit nicotine levels in cigarettes as far as it is not reduced to zero. The strategy is designed to reduce the addictiveness of cigarettes. However, nicotine related effects of the cigarettes with reduced nicotine content on various body systems are largely unknown. Following formal implementation of the regulatory policy what cardiovascular effects of reduced nicotine cigarettes, also called very low nicotine content cigarettes (VLNCC) are expected to persist is important to determine. This study will determine the cardiovascular effects of VLNCC such as change in heart rate, autonomic functions and indices of ventricular repolarization in smokers. Participants will be asked to smoke two VLNCC and one normal nicotine content cigarette (NNCC) while we will be recording their electrocardiogram (ECG) to see a change in heart rate, heart rate variability and indices of ventricular repolarization.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
DRUG	SPECTRUM cigarettes	SPECTRUM cigarettes have varying amount of nicotine content
OTHER	usual brand of Cigarettes	Usual Brand of Cigarettes

Timeline

• Start date: 2023-04-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-02-01
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study