Cardiovascular DiseasesNCT01785537
The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study
An observational study of Cardiovascular Diseases and Chronic Obstructive Pulmonary Diseases, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
Trial summary
The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Chronic Obstructive Pulmonary Diseases, Cancer of the Lung
- How many people
- 1,050 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult residents in the Abruzzo and Lazio Region of Italy that are smokers of traditional or electronic cigarettes
Who may be able to join
- resident into the Abruzzo and Lazio Region
- aged between 30 and 75 years;
- smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group);
- smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group);
- smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group).
Who cannot join
- illicit drug use,
- breastfeeding or pregnancy,
- major depression or other psychiatric conditions,
- severe allergies,
- active antihypertensive medication,
- angina pectoris,
- past episodes of major cardiovascular diseases (myocardial infarction, stroke/TIA, congestive heart failure, COPD, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Medicine and Aging Sciences, University of Chieti
Chieti, CH, 66100
About this study
Official title: Multicentric 5-year Follow-up Study to Assess the Efficacy of E-cigarettes as a Tool for Smoking Cessation and to Compare the Risk of Smoking-related Diseases Among Electronic and Traditional Cigarette Smokers, and Smokers of Both.
The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking.
The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit.
Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.
- Conditions
- Cardiovascular Diseases, Chronic Obstructive Pulmonary Diseases, Cancer of the Lung, Cancer of the Bladder, Cancer of the Stomach
- Keywords
- e-cigarette smoking, cigarette smoking, cardiovascular disease, hospitalization, chronic obstructive pulmonary diseases, observational study, efficacy, safety
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Urinary Bladder Neoplasms, Stomach Neoplasms, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarettes only | Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes | |
| Traditional cigarettes only | Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers. | |
| Mixed group | Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional smoking cessation rate
Percentage of subjects that were current (in TC and Mixed groups) or former (in EC group) smokers reporting sustained smoking abstinence from traditional cigarette smoking at 60 months. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. This outcome will be self-reported and checked using CO analyzer after breath.
Measured: 5 years
Change from baseline in the number of traditional cigarette smoked
Change in the average self-reported number of traditional cigarette smoked per day.
Measured: 6, 12, 24, 36 and 60 months.
Secondary outcomes (27)
Rate of subjects with smoking-related hospitalizations
Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once.
Measured: 5 years
Number of smoking-related hospitalizations
Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.
Measured: 5 years
Number of hospitalizations for cardiovascular diseases
Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted.
Measured: 5 years
Number of hospitalizations for smoking-related cancers
Mean number of hospital admissions for cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.
Measured: 5 years
Change from baseline in self-reported quality of life
Change in the average quality of life according to EuroQol EQ-D3.
Measured: 6, 12, 24 and 36 months
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
Time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission.
Measured: 5 year
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Self-reported side effects as measured by VAS and a structured report form.
Measured: 5 years
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Measured: 5 years
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
The primary outcome measure is time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission.
Measured: 3 years
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
The primary outcome measure is time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission.
Measured: 2 years
Rate of subjects with smoking-related hospitalizations
Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once.
Measured: 3 years
Rate of subjects with smoking-related hospitalizations
Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once.
Measured: 2 years
Number of smoking-related hospitalizations
Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.
Measured: 2 years
Number of smoking-related hospitalizations
Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.
Measured: 1 year
Smoking abstinence
Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit.
Measured: 3 years
Smoking abstinence
Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit.
Measured: 2 years
Smoking abstinence
Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit.
Measured: 1 year
Smoking abstinence
Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit.
Measured: 6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Self-reported side effects as measured by VAS and a structured report form.
Measured: 3 years
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Self-reported side effects as measured by VAS and a structured report form.
Measured: 2 years
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Self-reported side effects as measured by VAS and a structured report form.
Measured: 1 year
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Self-reported side effects as measured by VAS and a structured report form.
Measured: 6 months
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Measured: 3 years
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Measured: 2 years
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Measured: 1 year
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Measured: 6 months
Traditional and electronic smoking (overall smoking) cessation
Percentage of subjects in all groups reporting sustained smoking abstinence from both traditional and electronic cigarette smoking at 12 months. Smoking abstinence is defined as complete abstinence from tobacco or electronic smoking (not even a puff) for the 30 days period prior to the visit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, Catholic University of the Sacred Heart, University of Turin, Italy, University of Catania, Mario Negri Institute for Pharmacological Research
- Responsible party
- Principal investigator, Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Investigators
- Lamberto Manzoli, MD, MPH, Principal investigator, Department of Medicine and Aging Sciences, University of Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785537
- Sponsor's protocol ID
- CHLM001
- Status last verified
- May 2017
- First submitted
- 1 Feb 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manzoli L, La Vecchia C, Flacco ME, Capasso L, Simonetti V, Boccia S, Di Baldassarre A, Villari P, Mezzetti A, Cicolini G. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. BMC Public Health. 2013 Sep 24;13:883. doi: 10.1186/1471-2458-13-883.
PubMed 24063569Manzoli L, Flacco ME, Fiore M, La Vecchia C, Marzuillo C, Gualano MR, Liguori G, Cicolini G, Capasso L, D'Amario C, Boccia S, Siliquini R, Ricciardi W, Villari P. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. PLoS One. 2015 Jun 10;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015.
PubMed 26061661Manzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M. A cohort study of electronic cigarette use: Effectiveness and safety at 24 months. Tobacco Control 2016 Jun 7 (epub ahead of print). (doi: 10.1136/tobaccocontrol-2015-052822) Direct link: http://tobaccocontrol.bmj.com/content/early/2016/06/06/tobaccocontrol-2015-052822.full
Manzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M; ISLESE Working Group. Cohort study of electronic cigarette use: effectiveness and safety at 24 months. Tob Control. 2017 May;26(3):284-292. doi: 10.1136/tobaccocontrol-2015-052822. Epub 2016 Jun 6.
PubMed 27272748
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric 5-year Follow-up Study to Assess the Efficacy of E-cigarettes as a Tool for Smoking Cessation and to Compare the Risk of Smoking-related Diseases Among Electronic and Traditional Cigarette Smokers, and Smokers of Both.
- ClinicalTrials.gov ID
- NCT01785537
- Acronym / sponsor ID
- CHLM001
- Conditions
- Cardiovascular Diseases, Chronic Obstructive Pulmonary Diseases, Cancer of the Lung, Cancer of the Bladder, Cancer of the Stomach
- Keywords
- e-cigarette smoking, cigarette smoking, cardiovascular disease, hospitalization, chronic obstructive pulmonary diseases, observational study, efficacy, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, Catholic University of the Sacred Heart, University of Turin, Italy, University of Catania, Mario Negri Institute for Pharmacological Research
- Study start
- Oct 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking.
The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit.
Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E-cigarettes only | – | –Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes |
| Traditional cigarettes only | – | –Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers. |
| Mixed group | – | –Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult residents in the Abruzzo and Lazio Region of Italy that are smokers of traditional or electronic cigarettes
Key inclusion criteria (5 listed)
- resident into the Abruzzo and Lazio Region
- aged between 30 and 75 years;
- smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group);
- smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group);
- smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group).
Key exclusion criteria (7 listed)
- illicit drug use,
- breastfeeding or pregnancy,
- major depression or other psychiatric conditions,
- severe allergies,
- active antihypertensive medication,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Traditional smoking cessation rate
Time frame: 5 years
Percentage of subjects that were current (in TC and Mixed groups) or former (in EC group) smokers reporting sustained smoking abstinence from traditional cigarette smoking at 60 months. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. This outcome will be self-reported and checked using CO analyzer after breath.
Change from baseline in the number of traditional cigarette smoked
Time frame: 6, 12, 24, 36 and 60 months.
Change in the average self-reported number of traditional cigarette smoked per day.
27 secondary outcomes
Rate of subjects with smoking-related hospitalizations
Time frame: 5 years
Number of smoking-related hospitalizations
Time frame: 5 years
Number of hospitalizations for cardiovascular diseases
Time frame: 5 years
Number of hospitalizations for smoking-related cancers
Time frame: 5 years
Change from baseline in self-reported quality of life
Time frame: 6, 12, 24 and 36 months
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
Time frame: 5 year
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 5 years
Adherence to e-cigarette smoking
Time frame: 5 years
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
Time frame: 3 years
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
Time frame: 2 years
Rate of subjects with smoking-related hospitalizations
Time frame: 3 years
Rate of subjects with smoking-related hospitalizations
Time frame: 2 years
Number of smoking-related hospitalizations
Time frame: 2 years
Number of smoking-related hospitalizations
Time frame: 1 year
Smoking abstinence
Time frame: 3 years
Smoking abstinence
Time frame: 2 years
Smoking abstinence
Time frame: 1 year
Smoking abstinence
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 3 years
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 2 years
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 6 months
Adherence to e-cigarette smoking
Time frame: 3 years
Adherence to e-cigarette smoking
Time frame: 2 years
Adherence to e-cigarette smoking
Time frame: 1 year
Adherence to e-cigarette smoking
Time frame: 6 months
Traditional and electronic smoking (overall smoking) cessation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 24063569Manzoli L, La Vecchia C, Flacco ME, Capasso L, Simonetti V, Boccia S, Di Baldassarre A, Villari P, Mezzetti A, Cicolini G. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. BMC Public Health. 2013 Sep 24;13:883. doi: 10.1186/1471-2458-13-883.
- Results publication: PubMed 26061661Manzoli L, Flacco ME, Fiore M, La Vecchia C, Marzuillo C, Gualano MR, Liguori G, Cicolini G, Capasso L, D'Amario C, Boccia S, Siliquini R, Ricciardi W, Villari P. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. PLoS One. 2015 Jun 10;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015.
- Results publicationManzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M. A cohort study of electronic cigarette use: Effectiveness and safety at 24 months. Tobacco Control 2016 Jun 7 (epub ahead of print). (doi: 10.1136/tobaccocontrol-2015-052822) Direct link: http://tobaccocontrol.bmj.com/content/early/2016/06/06/tobaccocontrol-2015-052822.full
- Derived from this study: PubMed 27272748Manzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M; ISLESE Working Group. Cohort study of electronic cigarette use: effectiveness and safety at 24 months. Tob Control. 2017 May;26(3):284-292. doi: 10.1136/tobaccocontrol-2015-052822. Epub 2016 Jun 6.
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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.
Lamberto Manzoli, MD, MPH principal investigator
Department of Medicine and Aging Sciences, University of Chieti, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Chronic Obstructive Pulmonary Diseases, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 May 2017. 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?
Results are not available in the source record.
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?
Traditional smoking cessation rate (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT01785537, which also lists 4 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 5 May 2017.