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Heated Tobacco Products vs Electronic Cigarettes

NCT03569748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-06-25

Study results available
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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.

Conditions

  • Smoking, Cigarette

Interventions

DEVICE

IQOS

IQOS USE FOR 12 WEEKS

DEVICE

E-CIG

ELECTRONIC CIGARETTE FOR 12 WEEKS

Sponsors & Collaborators

  • Philip Morris Products S.A.

    collaborator INDUSTRY

  • University of Catania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-25
Primary Completion
2020-05-25
Completion
2020-05-25

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569748 on ClinicalTrials.gov