Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | |||||
Timepoint | -t 1 | 0 | t 0 | t 1 | t 2 | t 3 | t 4 | t x |
Enrolment: | ||||||||
Eligibility screen | X | |||||||
Informed consent | X | |||||||
Allocation | X | |||||||
Intervention: | ||||||||
Fixed-user setting (6mg/mL nicotine or 18mg/mL) | X | X | ||||||
Fixed-user setting (6mg/mL nicotine or 18mg/mL) | X | X | ||||||
Assessments: | ||||||||
Demographics (e.g. age, gender, ethnic group, educational qualification) | X | X | ||||||
Vaping and previous smoking history | X | X | ||||||
Breath carbon monoxide (CO) sample | X | X | X | X | X | |||
Puffing behaviour and participant reports | X | X | X | X | ||||
Mood and Physical Symptoms Scale (MPSS) to record withdrawal symptoms | X | X | X | X | X | |||
Urge to vape | X | X | X | X | X | |||
Saliva sample | X | X | X | X | X | |||
Urine sample | X | X | X | X | X | |||
Adverse events | X | X | X | X | X | |||
Participant feedback | X | |||||||
Debrief | X |