Nicotine DependenceNCT01195597
Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)
A study testing E-Cigarette 7.2 mg nicotine in people with Nicotine Dependence and Smoking Cessation, run by University of Catania at 1 site in Italy.
Trial summary
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking Cessation
- What is being tested?
- E-Cigarette 7.2 mg nicotine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Jul 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy smokers
- unwilling to quit
- age 18-60 years
- smoking ≥ 15 cig/day for at least 5 years
- exhaled CO level of ≥ 15 ppm
- FTND ≥ 5
Who cannot join
- alcohol and illicit drug use
- breastfeeding or pregnancy
- major depression or other psychiatric conditions
- previous experience with ENDD
- recent myocardial infarction
- angina pectoris
Show all 10Show fewer
- high blood pressure (BP>140mm Hg systolic and/or 90mmHg diastolic)
- diabetes mellitus
- severe allergies
- poorly controlled asthma or other airways diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)
Catania, 95124
About this study
Official title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.
This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.
Read the detailed description
Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The efficacy of these devices in smoking cessation and/or smoking reduction studies has never been investigated.
In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing on smoking reduction and smoking abstinence. Study participants were invited to attend four study visits: at baseline, week-4, week-8, and week-12. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
- Conditions
- Nicotine Dependence, Smoking Cessation
- Being tested
- E-Cigarette 7.2 mg nicotine
- Keywords
- electronic cigarette, ENDD, nicotine, smoking cessation, smoking reduction
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Vaping, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Cigarette 7.2 mg nicotineDevice
Also called E-Cigarette with nicotine cartridges
Participants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarette 7.2 mg nicotine | Experimental | Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. Receives: Device: E-Cigarette 7.2 mg nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).
Measured: number of cigarettes/day as assessed at week 24
Secondary outcomes (1)
Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)
Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24
Measured: number of cigarettes/day as assessed at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010
- Study completionJul 2010
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 Nicotine DependenceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Collaborators
- Lega Italiana Anti Fumo, Arbi Group Srl
- Responsible party
- Principal investigator, Riccardo Polosa, University of Catania
- Investigators
- Riccardo Polosa, MD, PhD, Principal investigator, Università di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195597
- Sponsor's protocol ID
- CAT00/10
- Status last verified
- Jan 2013
- First submitted
- 3 Sep 2010
- Last updated
- 9 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Polosa R, Morjaria JB, Caponnetto P, Campagna D, Russo C, Alamo A, Amaradio M, Fisichella A. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med. 2014 Aug;9(5):537-46. doi: 10.1007/s11739-013-0977-z. Epub 2013 Jul 20.
PubMed 23873169Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786. doi: 10.1186/1471-2458-11-786.
PubMed 21989407
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
- ClinicalTrials.gov ID
- NCT01195597
- Acronym / sponsor ID
- CAT00/10
- Conditions
- Nicotine Dependence, Smoking Cessation
- Keywords
- electronic cigarette, ENDD, nicotine, smoking cessation, smoking reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Collaborators
- Lega Italiana Anti Fumo, Arbi Group Srl
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Posted 11 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.
This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.
Detailed description
Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The efficacy of these devices in smoking cessation and/or smoking reduction studies has never been investigated.
In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing on smoking reduction and smoking abstinence. Study participants were invited to attend four study visits: at baseline, week-4, week-8, and week-12. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette 7.2 mg nicotine | Experimental | Device: E-Cigarette 7.2 mg nicotineWell characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy smokers
- unwilling to quit
- age 18-60 years
- smoking ≥ 15 cig/day for at least 5 years
- exhaled CO level of ≥ 15 ppm
Key exclusion criteria (10 listed)
- alcohol and illicit drug use
- breastfeeding or pregnancy
- major depression or other psychiatric conditions
- previous experience with ENDD
- recent myocardial infarction
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 |
|---|---|---|
| E-Cigarette 7.2 mg nicotineAlso: E-Cigarette with nicotine cartridgesParticipants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer | Device | E-Cigarette 7.2 mg nicotine |
Primary outcome
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
Time frame: number of cigarettes/day as assessed at week 24
Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).
1 secondary outcome
Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)
Time frame: number of cigarettes/day as assessed at week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23873169Polosa R, Morjaria JB, Caponnetto P, Campagna D, Russo C, Alamo A, Amaradio M, Fisichella A. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med. 2014 Aug;9(5):537-46. doi: 10.1007/s11739-013-0977-z. Epub 2013 Jul 20.
- Derived from this study: PubMed 21989407Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786. doi: 10.1186/1471-2458-11-786.
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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.
Riccardo Polosa, MD, PhD principal investigator
Università di Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Cigarette 7.2 mg nicotine in people with Nicotine Dependence and Smoking Cessation, 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 6 inclusion and 10 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 9 Jan 2013. 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 11 Sep 2012). 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?
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (time frame: number of cigarettes/day as assessed at week 24). 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 NCT01195597, 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 9 Jan 2013.