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Heated Tobacco Products vs Electronic Cigarettes

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ClinicalTrials.gov Identifier: NCT03569748
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Philip Morris Products S.A.
Information provided by (Responsible Party):
Enrico Gian Maria Mondati, University of Catania

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Device: IQOS Device: E-CIG Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IQOS
HEAT NOT BURN REDUCED RISK PRODUCT
Device: IQOS
IQOS USE FOR 12 WEEKS

Active Comparator: E-CIG
ELECTRONIC CIGARETTE REDUCED RISK PRODUCT
Device: E-CIG
ELECTRONIC CIGARETTE FOR 12 WEEKS




Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 12 WEEK ]
    to compare the efficacy of HTP and EC, in terms of quit rates at week 12, by self-reporting abstinence from classic cigarette [validated by an Exhaled breath Carbon monoxide (eCO) measurement ≤10ppm)]


Secondary Outcome Measures :
  1. Smoking Reduction [ Time Frame: Week 12 ]
    To compare the smoking reduction derived from the use of HTP and EC, intended as a 50% reduction in the number of conventional cigarette/day at week 12, defined through self-reporting;

  2. Adoption rate [ Time Frame: Week 12 ]
    To compare the adoption rate to product use [by collecting (empty) refill bottles and used heathsticks on a daily basis, verified by a study diary filled daily by the subject];

  3. Acceptability [ Time Frame: Week 12 ]
    To compare the acceptability derived from the use of HTP and EC [by a validated self-report inventory]

  4. Number of participants with product-related adverse events [ Time Frame: Week 12 ]
    To compare number of participants with adverse events derived from the use of HTP and EC as assessed by CTCAE v4.0

  5. Tobacco Harm Reduction [ Time Frame: Week 12 ]
    changes in Biomarkers of Biological Effects (BoBE) such as: eCO in the exhaled breath (i.e. eCO), step test values

  6. Reliability [ Time Frame: Baseline visit, Week 12 ]
    To compare the reliability of HTP and EC, in terms of incidence and kind of malfunctioning events, through self-reporting.



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:

  1. Able to comply with the study procedures
  2. Male or female healthy smokers aged ≥19
  3. Smoking at least 10 cigarettes a day
  4. Smoking for at least one year
  5. Not currently attempting to quit smoking or wishing to do so in the next 30 days (this will be verified at screening by the answer ''NO'' to both questions ''Do you intend to quit in the next 30 days?'' and ''Are you interested in taking part in one of our smoking cessation programs?'')
  6. Female smokers not planning to become pregnant are using an acceptable form of contraception.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrolment:

  1. Use of smokeless tobacco, or any other tobacco products (including e-cigarettes, cigars, chewing tobacco, snus, etc.) within the last 3 months, at baseline and during the whole study.
  2. Use of nicotine replacement therapy or other smoking cessation therapies within the last 3 months and at baseline.
  3. Self-reported pregnancy, planned pregnancy or breastfeeding.
  4. Tobacco industry employees and 1st degree relatives will be excluded in order to safeguard independence of the study

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569748


Contacts
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Contact: Enrico Mondati 00390953781583 emondati@unict.it

Locations
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Italy
University of Catania, Italy Recruiting
Catania, Italy
Contact: Enrico Mondati         
Sponsors and Collaborators
University of Catania
Philip Morris Products S.A.

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Responsible Party: Enrico Gian Maria Mondati, Researcher of Internal Medicine, University of Catania
ClinicalTrials.gov Identifier: NCT03569748     History of Changes
Other Study ID Numbers: 215/2017/PO
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrico Gian Maria Mondati, University of Catania:
smoking
harm reduction
electronic cigarette
heated tobacco product