NCT02897401

Brief 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"). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

September 7, 2016

Last Update Submit

September 7, 2016

Conditions

SmokingCarcinogenesis of the Nicotine

Keywords

urinary N'Nitrosonornicotinenicotineelectronic cigarettenicotine remplacement treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the inclusion

Secondary Outcomes (4)

  • NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"

    At the inclusion

  • NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine"

    At the inclusion

  • NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker"

    At the inclusion

  • NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine"

    At the inclusion

Study Arms (4)

Smocker

EXPERIMENTAL

Cigarette consumption in the context of their habit (not related to the particiapion under study).

Biological: pregnancy testBiological: Urinary NNN assesement

Electronic cigarette

EXPERIMENTAL

Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).

Biological: pregnancy testBiological: urinary cotinine assesmentBiological: Urinary NNN assesementBehavioral: 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).

Biological: pregnancy testBiological: Urinary NNN assesement

Without nicotine

PLACEBO COMPARATOR

No consumption in the context of their habit (not related to the particiapion under study).

Biological: pregnancy testBiological: urinary cotinine assesmentBiological: Urinary NNN assesementBehavioral: Questionnaire (Fagerstrom test)Procedure: Measurement of carbon monoxide levels expired

Interventions

pregnancy testBIOLOGICAL

Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center.

Electronic cigaretteNicotine replacement therapySmockerWithout nicotine
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.

Electronic cigaretteWithout nicotine
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.

Electronic cigaretteNicotine replacement therapySmockerWithout nicotine
Questionnaire (Fagerstrom test)BEHAVIORAL

This questionnaire will permit to assess the smoking habits of the participants.

Electronic cigaretteWithout nicotine
Measurement of carbon monoxide levels expiredPROCEDURE

This test will permit to determinate if the participant are axposed to passive smoking or not.

Electronic cigaretteWithout nicotine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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
  • +24 more criteria

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP, Paul Brousse Hospital

Villejuif, 94800, France

Location

MeSH Terms

Conditions

SmokingVaping

Interventions

Pregnancy TestsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and GynecologicalInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Patrick Dupont, MD

    APHP, Paul Brousse Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick DUPONT, MD

CONTACT

01.45.59.69.25patrick.dupont@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)