N/A
N=220
Heated Tobacco Products vs Electronic Cigarettes
Smoking, Cigarette
Bottom Line
View on ClinicalTrials.gov: NCT03569748 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Smoking Cessation — 60; 44 Participants — p=0.0051
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IQOS (Device); E-CIG (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Catania
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Smoking Cessation |
60; 44 | 0.0051 sig |
| SECONDARY Number of Participants Smoking Reduction |
100; 77 | 0.0003 sig |
| SECONDARY Adoption Rate |
102; 84 | 0.0003 sig |
| SECONDARY Acceptability |
0.73; -0.17 | — |
| SECONDARY Number of Participants With Product-related Adverse Events |
20; 24 | — |
| SECONDARY Changes in Biomarkers of Biological Effects (BoBE) |
8.2; 10.1 | — |
| SECONDARY Reliability |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- Able to comply with the study procedures
- Male or female healthy smokers aged ≥19
- Smoking at least 10 cigarettes a day
- Smoking for at least one year
- 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?'')
- 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:
- 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.
- Use of nicotine replacement therapy or other smoking cessation therapies within the last 3 months and at baseline.
- Self-reported pregnancy, planned pregnancy or breastfeeding.
- Tobacco industry employees and 1st degree relatives will be excluded in order to safeguard independence of the study
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Data sourced from ClinicalTrials.gov (NCT03569748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.