Clinical trial NCT05707871: Cardiovascular Effects of Very Low Nicotine Content Cigarettes
Official title: Cardiovascular Effects of Very Low Nicotine Content Cigarettes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Tobacco Use
Keywords: Cigarette smoking
Nicotine Content
Cardiovascular Disorders
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Within Subject
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility 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

Primary outcomes:
measure: Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
timeFrame: Hour 1
measure: Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
timeFrame: Hour 1
measure: Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
timeFrame: Hour 1
Secondary outcomes:
measure: Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
timeFrame: Hour 1
measure: Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
timeFrame: Hour 1
measure: Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
timeFrame: Hour 1
measure: Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
timeFrame: Hour 1
measure: Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC300/301(2.4mg nicotine)
timeFrame: Hour 1
measure: Change in electrocardiogram (ECG) Measures - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
timeFrame: Hour 1
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Eric C Donny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N Engl J Med. 1994 Jul 14;331(2):123-5. doi: 10.1056/NEJM199407143310212. No abstract available.
citation: Benowitz NL, Henningfield JE. Reducing the nicotine content to make cigarettes less addictive. Tob Control. 2013 May;22 Suppl 1(Suppl 1):i14-7. doi: 10.1136/tobaccocontrol-2012-050860.
citation: Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.
citation: Tachmes L, Fernandez RJ, Sackner MA. Hemodynamic effects of smoking cigarettes of high and low nicotine content. Chest. 1978 Sep;74(3):243-6. doi: 10.1378/chest.74.3.243.
citation: Moheimani RS, Bhetraratana M, Peters KM, Yang BK, Yin F, Gornbein J, Araujo JA, Middlekauff HR. Sympathomimetic Effects of Acute E-Cigarette Use: Role of Nicotine and Non-Nicotine Constituents. J Am Heart Assoc. 2017 Sep 20;6(9):e006579. doi: 10.1161/JAHA.117.006579.