CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 220 enrolled
Drug / intervention
IQOS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03569748
NCT03569748N/ACompleted

Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol

University of Catania·interventional·Posted Jun 26, 2018·Updated Jun 25, 2021

In Brief

A clinical study evaluating IQOS and E-CIG for Smoking, Cigarette. Completed, enrolled 220 participants across 1 site.

Detailed Summary

This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartMay 25, 2019
Primary CompletionMay 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 8.0 years ago

Interventions

IQOSdevice

IQOS USE FOR 12 WEEKS

E-CIGdevice

ELECTRONIC CIGARETTE FOR 12 WEEKS