Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Early Phase 1RecruitingNCT05707871

Wake Forest University Health Sciences49 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Tobacco Use

Interventions

SPECTRUM cigarettesDRUG

SPECTRUM cigarettes have varying amount of nicotine content

usual brand of CigarettesOTHER

Usual Brand of Cigarettes

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

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 - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

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 - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

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

Secondary Outcomes

Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

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 Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

Time frame: Hour 1

Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

Central Contacts

Maria Anwar, MS

CONTACT

802-922-3343 manwar@wakehealth.edu

Data from ClinicalTrials.gov

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