Recruiting
Early Phase 1

Very Low Nicotine

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05707871

Conditions

Tobacco Use

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

SPECTRUM cigarettes

usual brand of Cigarettes

Study Details

Brief summary:

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

Conditions

Tobacco Use

Study ID

NCT05707871

Start date

Apr 4, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

49 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Usual Brand of Cigarettes

Participants will smoke 2-3 cigarettes of their usual brand

experimental: Research Cigarettes (SPECTRUM)

Participants will smoke 1-2 SPECTRUM cigarettes

Interventions

SPECTRUM cigarettes

SPECTRUM cigarettes have varying amount of nicotine content

usual brand of Cigarettes

Usual Brand of Cigarettes

Primary outcome measure

  • Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine) [ Time Frame: Hour 1 ]
  • Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine) [ Time Frame: Hour 1 ]
  • Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine) [ Time Frame: Hour 1 ]

Central Contacts and Locations

Central contacts

Maria Anwar, MS

802-922-3343manwar@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Maria Anwar, MS

802-922-3343manwar@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Cigarette smoking
  • Nicotine Content
  • Cardiovascular Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-28.