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NCT05707871 | Recruiting | Tobacco Use


Cardiovascular Effects of Very Low Nicotine Content Cigarettes
Sponsor:

Wake Forest University Health Sciences

Brief Summary:

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

Condition or disease

Tobacco Use

Intervention/treatment

SPECTRUM cigarettes

usual brand of Cigarettes

Phase

Early Phase 1

Detailed 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.

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
Criteria
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

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Location Details


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Cardiovascular Effects of Very Low Nicotine Content Cigarettes

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

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