NCT05707871 · Wake Forest University Health Sciences
Cardiovascular Effects of Very Low Nicotine Content Cigarettes
(CEV)
What this study is about
The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers
View original scientific description
The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers
Interventions
DRUG
SPECTRUM cigarettes
SPECTRUM cigarettes have varying amount of nicotine content
OTHER
usual brand of Cigarettes
Usual Brand of Cigarettes
Primary outcome measures
Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
Time frame: Hour 1
Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
Time frame: Hour 1
Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
Time frame: Hour 1
Change in heart rate from pre-exposure to post-exposure for the normal nicotine content cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations