Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Tobacco Use Clinical Trial

— CEV  

Official title:

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707871
• Other study ID #: IRB00092813
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 4, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Maria Anwar, MS
• Phone: 802-922-3343
• Email: manwar[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Drug:
• SPECTRUM cigarettes
SPECTRUM cigarettes have varying amount of nicotine content

Other:
• usual brand of Cigarettes
Usual Brand of Cigarettes

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Hour 1
Primary	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)	Hour 1
Primary	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)	Hour 1
Secondary	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	Hour 1
Secondary	Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg 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	Hour 1
Secondary	Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg 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 Normal Nicotine Content Cigarettes (NNCC)s	Hour 1
Secondary	Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)	Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s	Hour 1
Secondary	Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC300/301(2.4mg nicotine)	Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC) s	Hour 1
Secondary	Change in electrocardiogram (ECG) Measures - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)	Measures of ventricular repolarization (Q-T interval, QTc, Tp-e interval)from pre-exposure to post-exposure for the Normal Nicotine Content Cigarettes (NNCC)s	Hour 1