Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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

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Tobacco Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Within Subject

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Participants will be blinded to content of nicotine in cigarettes

Study Groups

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Usual Brand of Cigarettes

Participants will smoke 2-3 cigarettes of their usual brand

Group Type ACTIVE_COMPARATOR

usual brand of Cigarettes

Intervention Type OTHER

Usual Brand of Cigarettes

Research Cigarettes (SPECTRUM)

Participants will smoke 1-2 SPECTRUM cigarettes

Group Type EXPERIMENTAL

SPECTRUM cigarettes

Intervention Type DRUG

SPECTRUM cigarettes have varying amount of nicotine content

Interventions

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SPECTRUM cigarettes

SPECTRUM cigarettes have varying amount of nicotine content

Intervention Type DRUG

usual brand of Cigarettes

Usual Brand of Cigarettes

Intervention Type OTHER

Other Intervention Names

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Cigarette Smoke

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes