Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
NCT Number: NCT05707871
The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Early Phase 1
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SPECTRUM cigarettes have varying amount of nicotine content
Other names: Cigarette Smoke
Usual Brand of Cigarettes
Time frame: Hour 1
Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
Time frame: Hour 1
Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
Time frame: Hour 1
Change in heart rate from pre-exposure to post-exposure for the normal nicotine content cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
Time frame: Hour 1
Change in measures of heart rate variability (HF, LF, LF/HF, RMSSD = root mean square of standard deviation; SDNN = standard deviation of normal-to-normal intervals, Total power) from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s
Time frame: Hour 1
Change in measures of heart rate variability (HF, LF, LF/HF, RMSSD = root mean square of standard deviation; SDNN = standard deviation of normal-to-normal intervals, Total power) from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s
Time frame: Hour 1
Change in measures of heart rate variability (HF, LF, LF/HF, RMSSD = root mean square of standard deviation; SDNN = standard deviation of normal-to-normal intervals, Total power) from pre-exposure to post-exposure for the Normal Nicotine Content Cigarettes (NNCC)s
Time frame: Hour 1
Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s
Time frame: Hour 1
Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC) s
Time frame: Hour 1
Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Normal Nicotine Content Cigarettes (NNCC)s
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Acronym: CEV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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