Cardiovascular Effects of Very Low Nicotine Content Cigarettes

NCT05707871 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB00092813
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use

Keywords

Cigarette smoking; Nicotine Content; Cardiovascular Disorders

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

  Hour 1

• Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

  Hour 1

• Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

  Hour 1

• Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

  Hour 1

• Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC300/301(2.4mg nicotine)

  Hour 1

Study Arms (2)

Usual Brand of Cigarettes

ACTIVE COMPARATOR

Participants will smoke 2-3 cigarettes of their usual brand

Other: usual brand of Cigarettes

Research Cigarettes (SPECTRUM)

EXPERIMENTAL

Participants will smoke 1-2 SPECTRUM cigarettes

Drug: SPECTRUM cigarettes

Interventions

SPECTRUM cigarettes DRUG

SPECTRUM cigarettes have varying amount of nicotine content

Also known as: Cigarette Smoke

Research Cigarettes (SPECTRUM)

usual brand of Cigarettes OTHER

Usual Brand of Cigarettes

Usual Brand of Cigarettes

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related 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.

  PMID: 7818638 BACKGROUND

• 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.

  PMID: 23591498 BACKGROUND

• 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.

  PMID: 20078491 BACKGROUND

• 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.

  PMID: 688779 BACKGROUND

• 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.

  PMID: 28931527 BACKGROUND

MeSH Terms

Conditions

Tobacco Use; Cigarette Smoking; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Smoking

Study Officials

• Eric C Donny, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Anwar, MS

CONTACT

802-922-3343; manwar@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to content of nicotine in cigarettes
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within Subject

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: April 4, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)