Table 3.
Schedule of assessments.
| Assessment | Screening | Admission (day 1) | On study (days 1-2) | Discharge (day 2) | Poststudy follow-upa |
| Participants are free to use NPb or smoke as usualc | ✓ | ✓ | ✓ | ✓ | ✓ |
| Participants collect used NPsd |
|
|
✓ |
|
|
| Unused pouch collection |
|
|
✓ |
|
|
| Informed consent | ✓ |
|
|
|
|
| Inclusion and exclusion criteria | ✓ |
|
|
|
|
| Sociodemographic data | ✓ |
|
|
|
|
| Medical history | ✓ |
|
|
|
|
| Prior and concomitant medications | ✓ | ✓ | ✓ | ✓ | ✓ |
| Tobacco and nicotine use history questionnaire | ✓ |
|
|
|
|
| Pregnancy test (urine and serum)e | ✓ | ✓ |
|
|
|
| COVID-19 test (Sweden only) | ✓ | ✓ |
|
|
|
| Height, weight, BMI, and waist circumference | ✓ |
|
|
|
|
| Vital signsf | ✓ | ✓ |
|
|
|
| 12-lead ECGg | ✓ |
|
|
|
|
| Physical examinationh | ✓ | ✓ |
|
✓ |
|
| Urinary cotinine screen (dipstick) | ✓ | ✓ |
|
|
|
| Urine drugs of abuse panel and alcohol screeni | ✓ | ✓ |
|
|
|
| Serum biochemistry and hematology | ✓ |
|
|
|
|
| Urinalysis | ✓ |
|
|
|
|
| Virology (hepatitis B and C and HIV) | ✓ |
|
|
|
|
| Exhaled carbon monoxide measurementj | ✓ | ✓ |
|
|
|
| Spirometry (without bronchodilator)k | ✓ |
|
|
|
|
| FeNOl measurementm |
|
|
✓ |
|
|
| 24-hour urine collection |
|
|
✓ |
|
|
| Blood sampling for biomarker analysisn |
|
|
✓ |
|
|
| Carotid intima-media thickness assessment |
|
|
✓ |
|
|
| Quality-of-life questionnaire |
|
|
✓ |
|
|
| Oral health assessment |
|
|
✓ |
|
|
| Adverse event recordingo | ✓ | ✓ | ✓ | ✓ | ✓ |
aWithin 7 days of discharge.
bNP: nicotine pouch.
cAt any time, unless it would interfere with study assessments.
dAll pouches used during confinement collected from participants in arm A commencing just before the start of 24-hour urine collection.
eUrine pregnancy test only at admission.
fIncludes pulse rate, systolic and diastolic blood pressure, respiratory rate, and tympanic temperature.
gECG: electrocardiogram.
hFull physical examination at screening; symptom-driven physical examination at admission and discharge, if deemed necessary.
iBy breath test (alcometer).
jNo food, smoking, or nicotine pouch use within 30 minutes before assessment.
kNo food within 2 hours before assessment; no smoking or nicotine pouch use within 1 hour before assessment.
lFeNO: fractional exhaled nitric oxide.
mNo food or drink within 1 hour before assessment; no smoking or nicotine pouch use within 30 minutes before assessment.
nBlood sampling for the following biomarker analysis: N-(2-cyanoethyl)valine, carboxyhemoglobin (drawn between 6 PM and 8 PM), lipid panel (for high-density lipoprotein analysis), soluble intercellular adhesion molecule-1, and white blood cell count.
oReporting begins at provision of informed consent.