Wake Forest University Health Sciences
The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers
Tobacco Use
SPECTRUM cigarettes
usual brand of Cigarettes
Early Phase 1
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.
Study Type : | Interventional |
Estimated Enrollment : | 25 participants |
Masking: | Single |
Masking Description: | Participants will be blinded to content of nicotine in cigarettes |
Primary Purpose: | Health Services Research |
Official Title: | Cardiovascular Effects of Very Low Nicotine Content Cigarettes |
Actual Study Start Date : | April 4, 2023 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Usual Brand of Cigarettes Participants will smoke 2-3 cigarettes of their usual brand |
Other: usual brand of Cigarettes |
Experimental: Research Cigarettes (SPECTRUM) Participants will smoke 1-2 SPECTRUM cigarettes |
Drug: SPECTRUM cigarettes |
Ages Eligible for Study: | 21 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157