Cardiovascular Effects of Very Low Nicotine Content Cigarettes (CEV)

Wake Forest University (WFU)

Status and phase: Enrolling; Early Phase 1

Conditions: Tobacco Use

Treatments: Other: usual brand of Cigarettes; Drug: SPECTRUM cigarettes

Study type: Interventional

Funder types: Other

Identifiers

NCT05707871

IRB00092813

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Usual Brand of Cigarettes

Active Comparator group

Description:

Participants will smoke 2-3 cigarettes of their usual brand

Treatment:

Other: usual brand of Cigarettes

Research Cigarettes (SPECTRUM)

Experimental group

Description:

Participants will smoke 1-2 SPECTRUM cigarettes

Treatment:

Drug: SPECTRUM cigarettes