SmokingCANICENCT02897401
Determination of Carcinogens Nicotine in Electronic Cigarettes Users
A study testing pregnancy test, urinary cotinine assesment and Urinary NNN assesement in people with Smoking and Carcinogenesis of the Nicotine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Carcinogenesis of the Nicotine
- What is being tested?
- pregnancy test, urinary cotinine assesment and Urinary NNN assesement
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Nov 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group1:
- Adults (18 years old and more)
- Exclusive daily smoker for more than 4 weeks, consuming 10 manufactured cigarettes per day or more
- With health insurance
- Group 2:
- Adults (18 years old and more)
Show all 40Show fewer
- Users of electronic cigarette EGO or MOD type for 4 weeks or more
- Using a nicotine dosage of 12mg / ml or more for at least 4 weeks
- Former smokers who consumed 10 cigarettes per day or more
- Having completely stopped smoking for at least 4 weeks
- No Subjected to passive smoking (verified by measuring carbon monoxide in exhaled air)
- With health insurance
- Group 3:
- Adults (18 years old and more)
- People in patch 21 mg / 24h or 25mg / 16h in the fourth week or more treatment
- Without taking oral nicotine or electronic cigarette for at least 4 weeks
- Not subject to passive smoking (verified by measuring carbon monoxide in exhaled air)
- Former smokers who consumed 10 cigarettes per day or more
- Having completely stopped smoking for at least 4 weeks
- With health insurance
- Group 4 (control group):
- Adults (18 years old and more)
- People Non-smoking, non-users of electronic cigarette, non-users of nicotine replacement therapy for at least 4 weeks
- Not subject to passive smoking (verified by measuring carbon monoxide in exhaled air)
- With health insurance
- Patients in Groups 1, 2 and 3 must have a urinary cotinine ≥ 100 (ratio cotinine / creatinine - Determination Cotinine DRI). Patients in group 4 must have a urinary cotinine ≤ 10 (cotinine / creatinine ratio - Determination Cotinine DRI)
- The thresholds of carbon monoxide from clinical experience are:
- Non current smoker: 0 to 5 parts per million (ppm)
- Passive smoker: 6 to 9 ppm
- Current active smoker : 10 ppm or more
- Non inclusion criteria
- Rolling tobacco, cigars, cigarillos, pipe, bidi, chicha, cannabis smockers during the last 4 weeks
- Users tobacco snuff or chewing tobacco during the last 4 weeks
- Users of oral nicotine replacement therapy (gum, lozenges, inhalers, oral spray) during the last 4 weeks.
- Users of drug for smoking cessation aid other than nicotinic treatment: Varenicline, Bupropion, clonidine, Cytisine during the last 4 weeks
- Pregnant or breastfeeding women
- Non-compliant or unable to follow directions
- Refusing to sign the informed consent
- Refusing to do the urine collection
- Under guardianship or any other protective measures
Who cannot join
- Group 1, 2 and 3:
- -Having an urinary cotinine <100 (ratio cotinine / creatinine - Determination Cotinine DRI)
- Group 4 (control group):
- Having an urinary cotinine> 10 (ratio cotinine / creatinine - Determination Cotinine DRI)
- The determination of urinary cotinine levels will be carried out centrally. The result will not be available at the inclusion visit. The included patients who do not have the urinary cotinine levels required for their group, will secondarily excluded from the study.
- The number of subjects in Groups 1, 2 and 3 with a ratio of cotinine would be less than 100 is expected to be negligible.A102
Trial locations and contacts
1 site in 1 country.
France1 site
APHP, Paul Brousse Hospital
Villejuif, 94800
Patrick Dupont, Dr, 01.45.59.69.25, patrick.dupont@aphp.fr
About this study
Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine").
The main objective of the study is to compare the level of urinary NNN in the electronic cigarette users versus the nicotine replacement therapy (patch) users.
Read the detailed description
The study has only one visit taking place as below:
- Verification of inclusion and non-inclusion criteria.
- Collection of the informed consent of the subject Given the non-invasive nature of the procedure, a period of reflection will be given to the subjects, however, information and obtaining consent will be made during the same visit.
- Collection of 5 mL of required for the pregnancy test in women of childbearing age. This collection does not need to be fasting. If this test is positive, the subject will not be included in the study.
- Collection of 30 mL of urine needed for the cotinine and the NNN quantitative analysis.
This collection does not need to be fasting.
Then , the urine sample is divided into two vials stored at -80 ° C:
- a 10 mL vial for the cotinine analysis,
- a 20 mL vial for the NNN analysis.
- Realization of the Fagerstrom test (FTCD) in order to evaluate subject smoking. This test is not done for the group 4 (group "without nicotine")
- Measurement of carbon monoxide in exhaled air If after signing the consent, the subject realizes that he cannot urinate or he did not enough urine during the inclusion visiting, the subject can come back the next working day to make the urine collection.
- Conditions
- Smoking, Carcinogenesis of the Nicotine
- Being tested
- pregnancy test, urinary cotinine assesment, Urinary NNN assesement, Questionnaire (Fagerstrom test), Measurement of carbon monoxide levels expired
- Keywords
- urinary N'Nitrosonornicotine, nicotine, electronic cigarette, nicotine remplacement treatment
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnancy testBiological
Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center.
urinary cotinine assesmentBiological
Collection of 10 mL of urinary sample for cotinine analysis. The analysis is maid during the study and is centralised at the hospital Paul Brousse.
Urinary NNN assesementBiological
Collection of 20 mL of urinary sample for NNN analysis. The analysis is maid at the end of the study and is centralised in a laboratory located at Strasbourg.
Questionnaire (Fagerstrom test)Behavioural
This questionnaire will permit to assess the smoking habits of the participants.
Measurement of carbon monoxide levels expiredProcedure or surgery
This test will permit to determinate if the participant are axposed to passive smoking or not.
| Study group | Role | What they receive |
|---|---|---|
| Smocker | Experimental | Cigarette consumption in the context of their habit (not related to the particiapion under study). Receives: Biological: pregnancy test; Biological: Urinary NNN assesement |
| Electronic cigarette | Experimental | Electronic cigarette consumption in the context of their habit (not related to the particiapion under study). Receives: Biological: pregnancy test; Biological: urinary cotinine assesment; Biological: Urinary NNN assesement; Behavioral: Questionnaire (Fagerstrom test); Procedure: Measurement of carbon monoxide levels expired |
| Nicotine replacement therapy | Experimental | Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study). Receives: Biological: pregnancy test; Biological: Urinary NNN assesement |
| Without nicotine | Placebo comparator | No consumption in the context of their habit (not related to the particiapion under study). Receives: Biological: pregnancy test; Biological: urinary cotinine assesment; Biological: Urinary NNN assesement; Behavioral: Questionnaire (Fagerstrom test); Procedure: Measurement of carbon monoxide levels expired |
What is being measured
The primary outcome is the main question the study is designed to answer.
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Measured: At the inclusion
Secondary outcomes (4)
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Measured: At the inclusion
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine"
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Measured: At the inclusion
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker"
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Measured: At the inclusion
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine"
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Dupont, MD, Principal investigator, APHP, Paul Brousse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897401
- Sponsor's protocol ID
- P150932
- Acronym
- CANICE
- Status last verified
- Aug 2016
- First submitted
- 7 Sep 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Carcinogens Nicotine in Electronic Cigarettes Users
- ClinicalTrials.gov ID
- NCT02897401
- Acronym / sponsor ID
- CANICE / P150932
- Conditions
- Smoking, Carcinogenesis of the Nicotine
- Keywords
- urinary N'Nitrosonornicotine, nicotine, electronic cigarette, nicotine remplacement treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 13 Sep 2016 (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.
Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine").
The main objective of the study is to compare the level of urinary NNN in the electronic cigarette users versus the nicotine replacement therapy (patch) users.
Detailed description
The study has only one visit taking place as below:
- Verification of inclusion and non-inclusion criteria.
- Collection of the informed consent of the subject Given the non-invasive nature of the procedure, a period of reflection will be given to the subjects, however, information and obtaining consent will be made during the same visit.
- Collection of 5 mL of required for the pregnancy test in women of childbearing age. This collection does not need to be fasting. If this test is positive, the subject will not be included in the study.
- Collection of 30 mL of urine needed for the cotinine and the NNN quantitative analysis.
This collection does not need to be fasting.
Then , the urine sample is divided into two vials stored at -80 ° C:
- a 10 mL vial for the cotinine analysis,
- a 20 mL vial for the NNN analysis.
- Realization of the Fagerstrom test (FTCD) in order to evaluate subject smoking. This test is not done for the group 4 (group "without nicotine")
- Measurement of carbon monoxide in exhaled air If after signing the consent, the subject realizes that he cannot urinate or he did not enough urine during the inclusion visiting, the subject can come back the next working day to make the urine collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smocker | Experimental | Biological: pregnancy test, Biological: Urinary NNN assesementCigarette consumption in the context of their habit (not related to the particiapion under study). |
| Electronic cigarette | Experimental | Biological: pregnancy test, Biological: urinary cotinine assesment, Biological: Urinary NNN assesement, Behavioral: Questionnaire (Fagerstrom test), Procedure: Measurement of carbon monoxide levels expiredElectronic cigarette consumption in the context of their habit (not related to the particiapion under study). |
| Nicotine replacement therapy | Experimental | Biological: pregnancy test, Biological: Urinary NNN assesementNicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study). |
| Without nicotine | Placebo comparator | Biological: pregnancy test, Biological: urinary cotinine assesment, Biological: Urinary NNN assesement, Behavioral: Questionnaire (Fagerstrom test), Procedure: Measurement of carbon monoxide levels expiredNo consumption in the context of their habit (not related to the particiapion under study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Group1:
- Group 2:
- Group 3:
- Group 4 (control group):
- Patients in Groups 1, 2 and 3 must have a urinary cotinine ≥ 100 (ratio cotinine / creatinine - Determination Cotinine DRI). Patients in group 4 must have a urinary cotinine ≤ 10 (cotinine / creatinine ratio - Determination Cotinine DRI)
Key exclusion criteria (6 listed)
- Group 1, 2 and 3:
- -Having an urinary cotinine <100 (ratio cotinine / creatinine - Determination Cotinine DRI)
- Group 4 (control group):
- The determination of urinary cotinine levels will be carried out centrally. The result will not be available at the inclusion visit. The included patients who do not have the urinary cotinine levels required for their group, will secondarily excluded from the study.
- The number of subjects in Groups 1, 2 and 3 with a ratio of cotinine would be less than 100 is expected to be negligible.A102
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 |
|---|---|---|
| pregnancy testCollection of 5 mL of urinary sample.The pregnancy test is done in each investigator center. | Biological | Electronic cigarette, Nicotine replacement therapy, Smocker, Without nicotine |
| urinary cotinine assesmentCollection of 10 mL of urinary sample for cotinine analysis. The analysis is maid during the study and is centralised at the hospital Paul Brousse. | Biological | Electronic cigarette, Without nicotine |
| Urinary NNN assesementCollection of 20 mL of urinary sample for NNN analysis. The analysis is maid at the end of the study and is centralised in a laboratory located at Strasbourg. | Biological | Electronic cigarette, Nicotine replacement therapy, Smocker, Without nicotine |
| Questionnaire (Fagerstrom test)This questionnaire will permit to assess the smoking habits of the participants. | Behavioural | Electronic cigarette, Without nicotine |
| Measurement of carbon monoxide levels expiredThis test will permit to determinate if the participant are axposed to passive smoking or not. | Procedure or surgery | Electronic cigarette, Without nicotine |
Primary outcome
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
Time frame: At the inclusion
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
4 secondary outcomes
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"
Time frame: At the inclusion
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine"
Time frame: At the inclusion
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker"
Time frame: At the inclusion
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine"
Time frame: At the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Patrick Dupont, MD principal investigator
APHP, Paul Brousse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pregnancy test, urinary cotinine assesment and Urinary NNN assesement in people with Smoking and Carcinogenesis of the Nicotine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 40 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. 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 France. 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. Some participants in this study may receive a placebo. 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?
Contact Patrick DUPONT, MD (01.45.59.69.25, patrick.dupont@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment". (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2016.