About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

SPECTRUM cigarettes
Drug
SPECTRUM cigarettes have varying amount of nicotine content
usual brand of Cigarettes
Other intervention
Usual Brand of Cigarettes

Treatment groups

49 Participants

are divided into 2 treatment groups

Group A: Usual Brand of CigarettesActive comparator 1 intervention

Group B: Research Cigarettes (SPECTRUM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame

Hour 1

2

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)

Time frame

Hour 1

3

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)

Time frame

Hour 1

Secondary outcomes

1

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

Time frame

Hour 1

2

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

Time frame

Hour 1

3

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

Time frame

Hour 1

4

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

Time frame

Hour 1

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts