Heated Tobacco Products vs Electronic Cigarettes

NCT03569748 | Completed Results DMC

• 1 other identifier: 215/2017/PO
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Cigarette

Keywords

smoking; harm reduction; electronic cigarette; heated tobacco product

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Smoking Cessation

  to compare the efficacy of HTP and EC, in terms of quit rates at week 12, by self-reporting abstinence from classic cigarette \[validated by an Exhaled breath Carbon monoxide (eCO) measurement ≤10ppm)\]

  12 WEEK

Secondary Outcomes (6)

• Number of Participants Smoking Reduction

  Week 12

• Adoption Rate

  Week 12

• Acceptability

  Week 12

• Number of Participants With Product-related Adverse Events

  Week 12

• Changes in Biomarkers of Biological Effects (BoBE)

  Week 12

Study Arms (2)

IQOS

EXPERIMENTAL

HEAT NOT BURN REDUCED RISK PRODUCT

Device: IQOS

E-CIG

ACTIVE COMPARATOR

ELECTRONIC CIGARETTE REDUCED RISK PRODUCT

Device: E-CIG

Interventions

IQOS DEVICE

IQOS USE FOR 12 WEEKS

IQOS

E-CIG DEVICE

ELECTRONIC CIGARETTE FOR 12 WEEKS

E-CIG

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead
• Philip Morris Products S.A.: collaborator

Study Sites (1)

University of Catania, Italy

Catania, Italy

Location

Related Publications (2)

• Caponnetto P, Campagna D, Maglia M, Benfatto F, Emma R, Caruso M, Caci G, Busa B, Pennisi A, Ceracchi M, Migliore M, Signorelli M. Comparing the Effectiveness, Tolerability, and Acceptability of Heated Tobacco Products and Refillable Electronic Cigarettes for Cigarette Substitution (CEASEFIRE): Randomized Controlled Trial. JMIR Public Health Surveill. 2023 Apr 4;9:e42628. doi: 10.2196/42628.

  PMID: 37014673 DERIVED

• Caponnetto P, Caruso M, Maglia M, Emma R, Saitta D, Busa B, Polosa R, Prosperini U, Pennisi A, Benfatto F, Sartorio C, Guastella M, Mondati E. Non-inferiority trial comparing cigarette consumption, adoption rates, acceptability, tolerability, and tobacco harm reduction potential in smokers switching to Heated Tobacco Products or electronic cigarettes: Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2020 Jan 8;17:100518. doi: 10.1016/j.conctc.2020.100518. eCollection 2020 Mar.

  PMID: 31956726 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Harm Reduction; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Maria Signorelli
• Organization: University of Catania

maria.signorelli@unict.it

095.378.2636/794

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Internal Medicine

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 26, 2018
• Study Start: May 25, 2019
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Locations

IT (1)