Caponnetto 2020.

Study name	Non‐inferiority trial comparing cigarette consumption, adoption rates, acceptability, tolerability, and tobacco harm reduction potential in smokers switching to Heated Tobacco Products or electronic cigarettes: Study protocol for a randomized controlled trial
Methods	RCT 12 weeks
Participants	220 healthy people who smoke tobacco cigarettes
Interventions	Arm 1 ‐ Heated Tobacco Products (HTPs) Arm 2 ‐ E‐cigarettes (ECs)
Outcomes	12‐week study. Follow‐up 24 weeks Biochemically‐verified self‐reported continuous abstinence at 12 weeks from the previous visit Secondary outcomes will include: smoking reduction from baseline, adoption rates and product acceptability, tolerability, changes in step test values and in the level of selected biomarkers of exposure in exhaled breath (i.e. eCO) and in spot urine samples A follow‐up visit at 24 weeks to review product usage and smoking behavior under naturalistic condition of use
Starting date	Recruitment May 2019, enrolment is expected to be completed in November 2019 Results to be reported in 2020
Contact information	Pasquale Caponnetto, p.caponnetto@unict.it
Notes	NCT03569748 Funded by Philip Morris