Skip to main content

Table 4 Schedule for first in-clinic evaluation of smokers

From: A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of a reduced toxicant prototype cigarette on biomarkers of exposure and of biological effect versus commercial cigarettes

Day and suggested times

Sampling

Procedure

12

1700 h (check in)

Blood, urine

Measure BP, PR, RR and temperature; abbreviated physical examination and medical history; illicit drug, alcohol and cotinine testing; pregnancy testing; collection of diary and cigarette butts; dinner

1900 h

None

Start first 24 h urine collection, monitoring of cigarette consumption and collection of filters

2100 h

None

Snack

13

0700 h

Blood

Measure BP, PR, RR and temperature; blood collection for creatinine in serum, biomarkers and gene expression

0800 h

None

Breakfast

To be scheduled

None

Assess smoking behavioura

1000 h

None

Administer sensory, quality-of-life and diet and lifestyle questionnairesb

1200 h

None

Lunch

1500 h

None

Measure exhaled CO

1700 h

Saliva

Saliva cotinine testing; dinner

1900 h

None

End first and start second 24 h urine collection, monitoring of cigarette consumption and collection of filters

2100 h

None

Snack

14

0700 h

Blood

Measure BP, PR, RR and temperature; blood collection for creatinine in serum, biomarkers and gene expression

0800 h

None

Breakfast

To be scheduled

None

Assess smoking behavioura

1100 h

None

Pulmonary-function test

1200 h

None

Lunch

1500 h

None

Measure exhaled CO

1700 h

Saliva

Saliva cotinine testing; dinner

1900 h

None

End second 24 h urine collection, monitoring of cigarette consumption and collection of filters; switch to next assigned product

2100 h

None

Snack

15

0700 h

None

Measure BP, PR, RR and temperature

0800 h

None

Breakfast

1000 h

None

Administer sensory questionnaire

1200 h

None

Lunch

1700 h

None

Dinner

1900 h

None

End filter collection; dispense interventional products and cigarette butt collection tins for use at home, remind participants of instructions for diet and completion of diaries

  1. BP, blood pressure, PR, pulse rate, RR, respiratory rate CO, carbon monoxide, aTo be performed by sponsor. bMay be done on day 14.