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    Clinical Trial Results:
    Efficacy of smoking cessation with varenicline for e-cigarettes users: a randomized controlled trial (VAREVAPE)

    Summary
    EudraCT number
    		 2016-000339-42
    Trial protocol
    		 IT  
    Global end of trial date
    31 Mar 2020

    Results information
    Results version number
    		 v1
    This version publication date
    05 Apr 2022
    First version publication date
    05 Apr 2022
    Other versions
    		 v2
    Summary report(s)
    		 Results

    Trial information

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    Trial identification
    Sponsor protocol code
    W1206810
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Unict: Unict
    Sponsors
    Sponsor organisation name
    Centro Prevenzione Cura Tabagismo
    Sponsor organisation address
    via Santa Sofia Catania, Catania, Italy,
    Public contact
    Medicina Interna, Centro per la prevenzione e cura tabagismo, AOU Policlinico Vittorio Emanuele- Università di Catania, 0039 0953781537, cpctunict@gmail.com
    Scientific contact
    Medicina Interna, Centro per la prevenzione e cura tabagismo, AOU Policlinico Vittorio Emanuele- Università di Catania, 0039 0953781537, cpctunict@gmail.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study intends to evaluate the efficacy and safety of varenicline 1 mg BID in the cessation of smoking electronic cigarette (single users) or combined use, electronic and classical cigarette (dual users).
    Protection of trial subjects
    Vital signs monitor
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 280
    Worldwide total number of subjects
    280
    EEA total number of subjects
    280
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    280
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Made by social media

    Pre-assignment
    Screening details
    		 At screening visit, participants were seen in a screening visit, during which informed consent was be obtained prior to any study procedures. Physical examination, blood pressure, pulse rate cardiological visit and electrocardiogram were done. A serum pregnancy test was completed for all females at the screening.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Varenicline plus Motivational Interviewing
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    varenicline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Buccal use
    Dosage and administration details
    0,5 mg

    Number of subjects in period 1
    		Varenicline plus Motivational Interviewing
    Started
    280
    Completed
    280

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Varenicline plus Motivational Interviewing
    Reporting group description
    		 -

    Primary: vaping cessation

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    End point title
    		 vaping cessation [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: "Validate full set data"
    End point values
    		 Varenicline plus Motivational Interviewing
    Number of subjects analysed
    280
    Units: numbers
    280
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: "Validate full set data"

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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