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Table 5 Schedules for second, third and fourth in-clinic evaluations 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

Days and suggested times

Sampling

Procedure

45, 76, 108

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; clinical laboratory tests; electrocardiography; lung- function tests; dinner

1900 h

None

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

2100 h

None

Snack

46, 77, 109

0700 h

Blood

Measure BP, PR, RR and temperature; measure creatinine in serum; biomarkers and gene expression

0800 h

None

Breakfast

1000 h

None

Administer sensory questionnaire; administer quality-of-life and diet and lifestyle questionnairesa

1200 h

None

Lunch

1500 h

None

Measure exhaled CO

1700 h

Saliva

Cotinine testing; dinner

1900 h

None

End 24 h urine collection, monitoring of cigarette consumption and collection of filters; 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, aOn day 108–109 visit only; may be conducted on either day.