Cross-Sectional Survey on the Use of Tobacco Products - Italy

Tobacco Use Clinical Trial

Official title:

Cross Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Italy (2018-2020)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03527004
• Other study ID #: P1-PMX-02-IT
• Status: Terminated
• Start date: March 20, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2024
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Italy.

Description:

The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Italy and in adult IQOS users registered in the IQOS user database of Philip Morris Italia S.r.l. (Italy IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:

1. Estimate the prevalence of current tobacco use status in the study population.

2. Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).

3. Explore the association between self-reported health status and use of tobacco products in the study population.

4. Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Italy registered in the Italy IQOS User Database.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6107
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (all participants, including IQOS users):

• Legally permitted to buy tobacco products in Italy (=18 years of age).

• Currently residing in Italy.

• Able to read, write and understand Italian.

• Consent to participate in the survey

Inclusion Criteria (IQOS users only):

• Has used more than 100 HEETS tobacco sticks in his or her lifetime.

• Is currently using IQOS.

• Has access to the internet.

• Is not currently employed by Philip Morris International or any of its affiliates

Exclusion Criteria:

• Not meeting the inclusion criteria.

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Survey on Use of Tobacco Products in the General Population
Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Italy.
• Survey on Use of Tobacco Products in IQOS Users
Online survey to describe patterns of use in IQOS users residing in Italy.

Locations

Country	Name	City	State
Switzerland	Philip Morris Products S.A.	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of current tobacco use	Prevalence of current tobacco use status in the study population.	Study duration (3 years).
Primary	Past tobacco use status	Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.	Study duration (3 years).
Primary	Self-reported health status	Association between self-reported health status and use of tobacco products in the study population.	Study duration (3 years).
Primary	Perceived risk	Association between patterns of use with perceived risk.	Study duration (3 years).
Primary	IQOS use experience	Describe the IQOS user experience, including motivation to use, mis-use, satisfaction, and self-reported changes since switching to the product (in a number of relevant domains where IQOS may have potential benefits).	Study duration (3 years).