Smoking, CigaretteNCT03569748
Heated Tobacco Products vs Electronic Cigarettes
A study testing IQOS and E-CIG in people with Smoking, Cigarette, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- IQOS and E-CIG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2019to 25 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Before the baseline visit, a face to face screening (V0) for pre-eligibility checks will be conducted. Subjects will be asked to practice with the step test for 10-15 minand will be instructed how to collect and store their morning urine before bringing it to the hospital on their Baseline visit (V1). This study will consist of a baseline visit (V1) and 6 follow-up study visits (V2-V7). At baseline (V1), participants will be randomized in two separate study groups. The randomization sequence will be computer generated by using blocks size of 5, with an allocation ratio of 1:1 for each of the study products (IQOS, JustFog-EC). Subjects will use and familiarize with their allocated product, as per randomization. They will be trained and counseled on the use of their allocated study product; oral explanation and practical demonstration will be followed by product trial during which participants will also have the option to try and choose their preferred flavour (either from a selection of 3 e-liquids or 3 tobacco sticks, depending on the allocated arm). Participants randomized in the IQOS arm will receive one iQOS kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those randomized in the JustFog-EC arm of the study will receive one JustFog Starter Kit and a full 1 week supply of e-liquids of their choice (they will receive 4, 10 mls refill containers).Free products will be supplied at each subsequent visit throughout the study. No supply of tobacco stick or e-liquid will be given at week-12, but users will be offered to keep using their products to minimize the risk of relapsing back to cigarette smoking. A prospective evaluation of cigarette consumption, adoption rates, acceptability and tolerability will be recorded throughout the study.
Visit 2 (V2):This will be scheduled 1 week after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured and product use recorded. Full 1 week supply of the chosen product will be provided.
Visit 3 (V3):This will be scheduled 2 weeks after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured and product use recorded. Participants will be instructed on how to collect and store their second urine sample before bringing it to the hospital at V4. Full 2 weeks supply of the chosen product will be provided.
Visit 4 (V4):This will be scheduled 4 weeks after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured, questionnaires completed and product use recorded. Step test will be carried out. Second urine sample will be collected, aliquotted and stored. Full 4 weeks supply of the chosen product will be provided.
Visit 5 (V5):This will be scheduled 8 weeks after V1 (with a tolerance of +/- 7 days). Cigarette/day, eCO, AEs, BP, HR will be measured, questionnaires completed and product use recorded. Full 4 weeks supply of the chosen product will be provided.
Visit 6 (V6):This will be scheduled 12 weeks after V1 (with a tolerance of +/- 7 days). Cigarette/day, eCO, AEs, BP, HR, weight, height will be measured, questionnaires completed and product use recorded. Step test will be carried out. No more products will be dispensed.
Follow-up Visit (V7):This final visit will be scheduled 24 weeks after V1 (with a tolerance of +/- 7 days)to review product usage and smoking behavior under naturalistic condition of use. Cigarette/day, eCO, AEs, BP, HR, weight, height will be measured, questionnaires completed and product use recorded. Step test will be carried out.
Data will be recorded from every subject on an electronic CRF, provided by a CRO, GCP compliant, 21 CFR Part 11 FDA compliant, listed in AIFA list of operating CRO. Urine samples will be collected at baseline and wk 4, and sent to an external laboratory for analytical assessment of selected Biomarkers of Exposure (BoE).
The study will be conducted at the University of Catania, Catania, Italy.
Participants Healthy smokers, not motivated to quit, will be randomized in two intervention groups in a 1:1 ratio to compare HTPs vs ECs in terms of reductions in cigarette consumption, adoption rate and acceptability, tolerability, and tobacco harm reduction. Sample size determination (better detailed below, in the relevant section) for no-inferiority testing is based on the assumptions that 1) expected quit rates based on most recent EC literature is about 20-25% and 2) that differences in quit rates between products under investigation should not exceed 10-15% (as per non-inferiority definition). According to these hypotheses the required number of participants per study arm is 104. Hence investigators intend to include 220 participants, 110 per group.
Study Products Tested
- Heated Tobacco Product (HTP):Investigators will use a HTP that does not involve combustion, generating a nicotine-containing aerosol. At the time of writing, IQOS is the only HTP available on the Italian market. IQOS is composed by: 1) a tobacco stick - a novel patent-pending tobacco product with unique processed tobacco made from tobacco powder; 2) an electronic holder into which the tobacco stick is inserted and which heats the tobacco by means of an electronically controlled heating blade; 3) a charger that is used to recharge the holder after each use.
- Investigators will use the three types of tobacco sticks specifically designed for IQOS(named HEETS) that are currently for sale in the Italian market: Heets Amber, Heets Yellow, and Heets Turquoise. These products are compliant to the EU Tobacco Product Directive.
- Electronic Cigarette (EC):JustFog Q16 Starter Kit and three types of e-liquid flavours, Puff Riserva Country 16 mg, Puff Riserva Toscana 16 mg, and Puff Artic 16 mg (2 tobacco-flavours and one menthol flavour), were chosen for the study.
- Products were selected by an Italian expert panel of 3 e-liquid producers and 3 vaping product distributors, moderated by the editor of a popular e-cigarette blog. Experts convened in Verona (Italy) during a major vaping expo event. Through consensus, the expert panel provided specific recommendation on the device(JustFog Q16 Starter Kit is one of the most popular e-cigarette device in Italy due to its good performance and quality, affordable price, and user friendliness especially for beginners) and the choice of e-liquids that could best match the sensorial experience of the iQOS tobacco sticks to be used in a switching study and minimize the local irritant effects of excessive PG/VG ratio. These products are compliant to the EU Tobacco Product Directive.
- Conditions
- Smoking, Cigarette
- Being tested
- IQOS, E-CIG
- Keywords
- smoking, harm reduction, electronic cigarette, heated tobacco product
- Medical subject headings
- Cigarette Smoking, Smoking, Harm Reduction, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQOSDevice
IQOS USE FOR 12 WEEKS
E-CIGDevice
ELECTRONIC CIGARETTE FOR 12 WEEKS
| Study group | Role | What they receive |
|---|---|---|
| IQOS | Experimental | HEAT NOT BURN REDUCED RISK PRODUCT Receives: Device: IQOS |
| E-CIG | Active comparator | ELECTRONIC CIGARETTE REDUCED RISK PRODUCT Receives: Device: E-CIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 12 WEEK
Secondary outcomes (6)
Number of Participants Smoking Reduction
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;
Measured: Week 12
Adoption Rate
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];
Measured: Week 12
Acceptability
To compare the acceptability derived from the use of HTP and EC by the modified Cigarette Evaluation Questionnaire (mCEQ). It is a self-administered questionnaire that contains 12 items covering both reinforcing and aversive effects of smoking. The items are rated on a 7-point scale from 1 not at all to 7 extremely
The total mCEQ score range from min 12 to max 84. Higher scores for the total mCEQ reflect a better outcome. There are also the following 5 subscales:
- Smoking Satisfaction (items 1, 2, 12) range of scores min 3 max 21;higher scores mean a better outcome.
- Psychological Reward (items 4-8), range of scores min 5 max 35; higher scores mean a better outcome.
- Aversion (items 9 and 10), range of scores min 2 max 14;higher scores mean a worse outcome.
- Single item score Enjoyment Respiratory Tract Sensations (item 3) range scores min 1 max 7;higher scores mean a better outcome.
- Single item score Craving Reduction (item 11), higher scores mean a better outcome
Measured: Week 12
Number of Participants With Product-related Adverse Events
To compare number of participants with adverse events derived from the use of HTP and EC as assessed by CTCAE v4.0
Measured: Week 12
Changes in Biomarkers of Biological Effects (BoBE)
changes in Biomarkers of Biological Effects (BoBE) such as: eCO in the exhaled breath (i.e. eCO), step test values
Measured: Week 12
Reliability
To compare the reliability of HTP and EC, in terms of incidence and kind of malfunctioning events, through self-reporting.
Measured: Baseline visit, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start25 May 2019
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris Products S.A.
- Responsible party
- Principal investigator, Enrico Gian Maria Mondati, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569748
- Sponsor's protocol ID
- 215/2017/PO
- Status last verified
- Jun 2021
- First submitted
- 14 May 2018
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37014673Caponnetto 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.
PubMed 31956726
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03569748
- Acronym / sponsor ID
- 215/2017/PO
- Conditions
- Smoking, Cigarette
- Keywords
- smoking, harm reduction, electronic cigarette, heated tobacco product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Collaborators
- Philip Morris Products S.A.
- Study start
- 25 May 2019 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Before the baseline visit, a face to face screening (V0) for pre-eligibility checks will be conducted. Subjects will be asked to practice with the step test for 10-15 minand will be instructed how to collect and store their morning urine before bringing it to the hospital on their Baseline visit (V1). This study will consist of a baseline visit (V1) and 6 follow-up study visits (V2-V7). At baseline (V1), participants will be randomized in two separate study groups. The randomization sequence will be computer generated by using blocks size of 5, with an allocation ratio of 1:1 for each of the study products (IQOS, JustFog-EC). Subjects will use and familiarize with their allocated product, as per randomization. They will be trained and counseled on the use of their allocated study product; oral explanation and practical demonstration will be followed by product trial during which participants will also have the option to try and choose their preferred flavour (either from a selection of 3 e-liquids or 3 tobacco sticks, depending on the allocated arm). Participants randomized in the IQOS arm will receive one iQOS kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those randomized in the JustFog-EC arm of the study will receive one JustFog Starter Kit and a full 1 week supply of e-liquids of their choice (they will receive 4, 10 mls refill containers).Free products will be supplied at each subsequent visit throughout the study. No supply of tobacco stick or e-liquid will be given at week-12, but users will be offered to keep using their products to minimize the risk of relapsing back to cigarette smoking. A prospective evaluation of cigarette consumption, adoption rates, acceptability and tolerability will be recorded throughout the study.
Visit 2 (V2):This will be scheduled 1 week after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured and product use recorded. Full 1 week supply of the chosen product will be provided.
Visit 3 (V3):This will be scheduled 2 weeks after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured and product use recorded. Participants will be instructed on how to collect and store their second urine sample before bringing it to the hospital at V4. Full 2 weeks supply of the chosen product will be provided.
Visit 4 (V4):This will be scheduled 4 weeks after V1 (with a tolerance of +/- 3 days). Cigarette/day, eCO, AEs, BP, HR will be measured, questionnaires completed and product use recorded. Step test will be carried out. Second urine sample will be collected, aliquotted and stored. Full 4 weeks supply of the chosen product will be provided.
Visit 5 (V5):This will be scheduled 8 weeks after V1 (with a tolerance of +/- 7 days). Cigarette/day, eCO, AEs, BP, HR will be measured, questionnaires completed and product use recorded. Full 4 weeks supply of the chosen product will be provided.
Visit 6 (V6):This will be scheduled 12 weeks after V1 (with a tolerance of +/- 7 days). Cigarette/day, eCO, AEs, BP, HR, weight, height will be measured, questionnaires completed and product use recorded. Step test will be carried out. No more products will be dispensed.
Follow-up Visit (V7):This final visit will be scheduled 24 weeks after V1 (with a tolerance of +/- 7 days)to review product usage and smoking behavior under naturalistic condition of use. Cigarette/day, eCO, AEs, BP, HR, weight, height will be measured, questionnaires completed and product use recorded. Step test will be carried out.
Data will be recorded from every subject on an electronic CRF, provided by a CRO, GCP compliant, 21 CFR Part 11 FDA compliant, listed in AIFA list of operating CRO. Urine samples will be collected at baseline and wk 4, and sent to an external laboratory for analytical assessment of selected Biomarkers of Exposure (BoE).
The study will be conducted at the University of Catania, Catania, Italy.
Participants Healthy smokers, not motivated to quit, will be randomized in two intervention groups in a 1:1 ratio to compare HTPs vs ECs in terms of reductions in cigarette consumption, adoption rate and acceptability, tolerability, and tobacco harm reduction. Sample size determination (better detailed below, in the relevant section) for no-inferiority testing is based on the assumptions that 1) expected quit rates based on most recent EC literature is about 20-25% and 2) that differences in quit rates between products under investigation should not exceed 10-15% (as per non-inferiority definition). According to these hypotheses the required number of participants per study arm is 104. Hence investigators intend to include 220 participants, 110 per group.
Study Products Tested
- Heated Tobacco Product (HTP):Investigators will use a HTP that does not involve combustion, generating a nicotine-containing aerosol. At the time of writing, IQOS is the only HTP available on the Italian market. IQOS is composed by: 1) a tobacco stick - a novel patent-pending tobacco product with unique processed tobacco made from tobacco powder; 2) an electronic holder into which the tobacco stick is inserted and which heats the tobacco by means of an electronically controlled heating blade; 3) a charger that is used to recharge the holder after each use.
- Investigators will use the three types of tobacco sticks specifically designed for IQOS(named HEETS) that are currently for sale in the Italian market: Heets Amber, Heets Yellow, and Heets Turquoise. These products are compliant to the EU Tobacco Product Directive.
- Electronic Cigarette (EC):JustFog Q16 Starter Kit and three types of e-liquid flavours, Puff Riserva Country 16 mg, Puff Riserva Toscana 16 mg, and Puff Artic 16 mg (2 tobacco-flavours and one menthol flavour), were chosen for the study.
- Products were selected by an Italian expert panel of 3 e-liquid producers and 3 vaping product distributors, moderated by the editor of a popular e-cigarette blog. Experts convened in Verona (Italy) during a major vaping expo event. Through consensus, the expert panel provided specific recommendation on the device(JustFog Q16 Starter Kit is one of the most popular e-cigarette device in Italy due to its good performance and quality, affordable price, and user friendliness especially for beginners) and the choice of e-liquids that could best match the sensorial experience of the iQOS tobacco sticks to be used in a switching study and minimize the local irritant effects of excessive PG/VG ratio. These products are compliant to the EU Tobacco Product Directive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQOS | Experimental | Device: IQOSHEAT NOT BURN REDUCED RISK PRODUCT |
| E-CIG | Active comparator | Device: E-CIGELECTRONIC CIGARETTE REDUCED RISK PRODUCT |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQOSIQOS USE FOR 12 WEEKS | Device | IQOS |
| E-CIGELECTRONIC CIGARETTE FOR 12 WEEKS | Device | E-CIG |
Primary outcome
Number of Participants With 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)]
6 secondary outcomes
Number of Participants Smoking Reduction
Time frame: Week 12
Adoption Rate
Time frame: Week 12
Acceptability
Time frame: Week 12
Number of Participants With Product-related Adverse Events
Time frame: Week 12
Changes in Biomarkers of Biological Effects (BoBE)
Time frame: Week 12
Reliability
Time frame: Baseline visit, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37014673Caponnetto 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.
- Derived from this study: PubMed 31956726Caponnetto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQOS and E-CIG in people with Smoking, Cigarette, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Smoking Cessation (time frame: 12 WEEK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569748, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.