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    Clinical Trial Results:
    An open label pragmatic randomised controlled trial of nicotine patch preloading for smoking cessation.

    Summary
    EudraCT number
    		 2011-005134-19
    Trial protocol
    		 GB  
    Global end of trial date
    12 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2017
    First version publication date
    28 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RG_11-171
    Additional study identifiers
    ISRCTN number
    		 ISRCTN33031001
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Churchill Hospital, Oxford, United Kingdom, OX3 7LE
    Public contact
    Heather House, University of Oxford, 0044 01865 572245, heather.house@admin.ox.ac.uk
    Scientific contact
    Heather House, University of Oxford, 0044 01865 572245, heather.house@admin.ox.ac.uk
    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
    01 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives are: 1. To examine the relative efficacy of nicotine patch worn for four weeks prior to quitting plus standard NHS care post-quit versus standard care only in smokers undergoing NHS treatment for tobacco dependence. 2. To examine the adverse effects and safety of the nicotine pre-treatment.
    Protection of trial subjects
    A risk assessment was carried out in accordance with MHRA guidance on Risk Adapted Approaches to Monitoring. A suitable monitoring plan was drawn up and appropriate on-site and central monitoring performed.
    Background therapy
    		 In both arms, at the first and second contacts in both arms, we facilitated contact between the participant and the local stop smoking services and wrote a referral letter to encourage the stop smoking service to work with us on respecting the preloading treatment. In particular, we asked the stop smoking advisors to ignore the presence or absence of preloading when discussing and recommending pharmacotherapy for use to support the quit attempt. We especially asked advisors to feel free to use varenicline, which starts prior to quit day and hence would be used concurrently with nicotine preloading. This is because we were keen that the treatment provided by the stop smoking services did not differ between trial arms. The NHS trains stop smoking advisors to give weekly behavioural support starting 1-2 weeks prior to quit day and continuing until at least four weeks after quit day. This support addresses issues such as planning for the quit day, the ‘not a puff rule’, and how to deal with difficult situations, such as others smoking around the quitter. It also provides monitoring of behaviour and validation of abstinence through carbon monoxide testing. The support is largely withdrawal-orientated therapy.
    Evidence for comparator
    		 The research team were keen to offer participants in the control arm a placebo, but the funding would not allow this. We were concerned that offering no treatment would lead to disengagement and, to counteract this, we developed a behavioural intervention which could seem plausible to participants but had no evidence that it would increase abstinence. We asked participants to consider their smoking pattern, the triggers for particular cigarettes, and to plan ways to reduce these cues. Such a process is standard in smoking cessation support anyway, so that participants in the intervention group were likely to engage in this after preloading and in preparation for quitting. As in the intervention group, the control group received a booklet outlining this process, which was designed to be comparable to the booklet supplied to the intervention group. As in the intervention group, participants in the control group were referred to the NHS Stop Smoking Service to commence a quit attempt between three and five weeks after enrolment.
    Actual start date of recruitment
    13 Aug 2012
    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
    United Kingdom: 1792
    Worldwide total number of subjects
    1792
    EEA total number of subjects
    1792
    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)
    1561
    From 65 to 84 years
    229
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 four recruitment centres Birmingham, Bristol and Nottingham, all recruiting between 1 February 2012 and March 2016

    Pre-assignment
    Screening details
    		 Inclusion criteria: Regular smokers of cigarettes, cigars, and rollup tobacco cigarettes, with or without marijuana aged ≥18 years of age. People who would be suitable for preloading in the judgement of the researcher Prepared to set a quit day in four weeks.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 preloading
    Arm description
    		 In the intervention arm, participants wore a 21mg nicotine patch daily for an intended four weeks prior to quit day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nicotine replacement therapy patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    21 mg Niquitin CQ Glaxo Smith Kline Consumer Healthcare daily nicotine patch worn for four weeks before their smoking quit day, from the day of their enrolment. They were advised to wear the patch for 24 hours a day.

    Arm title
    		 control
    Arm description
    		 standard smoking cessation support only
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		preloading control
    Started
    899
    893
    6 months
    728
    733
    Completed
    689
    700
    Not completed
    210
    193
         Adverse event, serious fatal
    -
    2
         died
    4
    -
         Lost to follow-up
    195
    171
         withdrawn
    11
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    preloading
    Reporting group description
    		 In the intervention arm, participants wore a 21mg nicotine patch daily for an intended four weeks prior to quit day.

    Reporting group title
    control
    Reporting group description
    		 standard smoking cessation support only

    Reporting group values
    		 preloading control Total
    Number of subjects
    		 899 893 1792
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.1 ( 13.3 ) 48.8 ( 13.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 426 423 849
        Male
    		 473 470 943
    carbon monoxide
    carbon monoxide reading
    Units: parts per million
        arithmetic mean (standard deviation)
    		 23.5 ( 12.3 ) 23.8 ( 12.8 ) -
    nicotine dependence
    nicotine dependence (NCSCT)
    Units: scale 0 to 10
        arithmetic mean (standard deviation)
    		 5.22 ( 2.2 ) 5.2 ( 2.24 ) -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all patients randomised irrespective of whether the participants received any trial medication and irrespective of whether they completed

    Subject analysis sets values
    		 ITT
    Number of subjects
    1792
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    age continuous
    Units: years
        arithmetic mean (standard deviation)
    48.9 ( 13.4 )
    Gender categorical
    Units: Subjects
        Female
    849
        Male
    943
    carbon monoxide
    carbon monoxide reading
    Units: parts per million
        arithmetic mean (standard deviation)
    23.7 ( 12.5 )
    nicotine dependence
    nicotine dependence (NCSCT)
    Units: scale 0 to 10
        arithmetic mean (standard deviation)
    5.21 ( 2.2 )

    End points

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    End points reporting groups
    Reporting group title
    preloading
    Reporting group description
    		 In the intervention arm, participants wore a 21mg nicotine patch daily for an intended four weeks prior to quit day.

    Reporting group title
    control
    Reporting group description
    		 standard smoking cessation support only

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all patients randomised irrespective of whether the participants received any trial medication and irrespective of whether they completed

    Primary: smoking abstinence at 6 months (russell criteria)

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    End point title
    		 smoking abstinence at 6 months (russell criteria)
    End point description
    smoking abstinence 6 months after quit date
    End point type
    Primary
    End point timeframe
    6 months after quit date
    End point values
    		 preloading control
    Number of subjects analysed
    899 [1]
    893 [2]
    Units: 0 1
        no
    573
    608
        yes
    326
    285
    Notes
    [1] - ITT
    [2] - ITT
    Statistical analysis title
    		 abstinence at 6 months
    Statistical analysis description
    logistic regression with adjustment for centre
    Comparison groups
    preloading v control
    Number of subjects included in analysis
    1792
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.081
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.62

    Secondary: russell standard abstinence at 4 weeks

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    End point title
    		 russell standard abstinence at 4 weeks
    End point description
    validated abstinence at 4 weeks after quit date
    End point type
    Secondary
    End point timeframe
    4 weeks after quit date
    End point values
    		 preloading control ITT
    Number of subjects analysed
    899
    893
    1792
    Units: 0 1
        no
    573
    608
    1181
        yes
    326
    285
    611
    Statistical analysis title
    		 validated abstinence at 4 weeks
    Statistical analysis description
    logistic regression for validated abstinence at 4 weeks adjusted for centre
    Comparison groups
    preloading v control
    Number of subjects included in analysis
    1792
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.48

    Secondary: 7 day point prevalence abstinence at 4 weeks

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    End point title
    		 7 day point prevalence abstinence at 4 weeks
    End point description
    point prevalence abstinence at 4 weeks after quit date
    End point type
    Secondary
    End point timeframe
    4 weeks after quit date
    End point values
    		 preloading control
    Number of subjects analysed
    899
    893
    Units: 0 1
        no
    580
    605
        yes
    319
    288
    Statistical analysis title
    		 7 day point prevalence abstinence at 4 weeks
    Statistical analysis description
    logistic regression adjusted for centre
    Comparison groups
    preloading v control
    Number of subjects included in analysis
    1792
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.149
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.41

    Secondary: 7 day point prevalence abstinence at 6 months

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    End point title
    		 7 day point prevalence abstinence at 6 months
    End point description
    7 day point prevalence abstinence at 6 months after quit date
    End point type
    Secondary
    End point timeframe
    6 months after quit date
    End point values
    		 preloading control
    Number of subjects analysed
    899
    893
    Units: 0 1
        no
    699
    712
        yes
    200
    181
    Statistical analysis title
    		 7 day point prevalence abstinence at 6 months
    Statistical analysis description
    logistic regression adjusted for centre
    Comparison groups
    preloading v control
    Number of subjects included in analysis
    1792
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.306
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.41

    Secondary: 12 months validated abstinence

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    End point title
    		 12 months validated abstinence
    End point description
    12 months validated abstinence after quit date
    End point type
    Secondary
    End point timeframe
    12 months after quit date
    End point values
    		 preloading control
    Number of subjects analysed
    899
    893
    Units: 0 1
        no
    773
    792
        yes
    126
    101
    Statistical analysis title
    		 12 months validated abstinence
    Statistical analysis description
    logistic regression adjusted for centre
    Comparison groups
    preloading v control
    Number of subjects included in analysis
    1792
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.085
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.69

    Secondary: 7 day point prevalence abstinence at 12 months

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    End point title
    		 7 day point prevalence abstinence at 12 months
    End point description
    7 day point prevalence abstinence 12 months after quit date
    End point type
    Secondary
    End point timeframe
    12 months after quit date
    End point values
    		 preloading control
    Number of subjects analysed
    899
    893
    Units: 0 1
        no
    698
    723
        yes
    201
    170
    Statistical analysis title
    		 7 day point prevalence abstinence at 12 months
    Statistical analysis description
    logistic regression with adjustment for centre
    Comparison groups
    preloading v control
    Number of subjects included in analysis
    1792
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.082
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.54

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    adverse events are those that occurred after baseline and until one week after quit day. In the protocol, we deemed that we would report only adverse events of moderate severity or above i.e. those that hindered normal activities
    Adverse event reporting additional description
    we elicited adverse events from participants in both arms at contacts -3 weeks (one week after baseline) and at +1 week (five weeks after baseline and one week after quit day).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    preloading
    Reporting group description
    		 In the intervention arm, participants wore a 21mg nicotine patch daily for an intended four weeks prior to quit day.

    Reporting group title
    control
    Reporting group description
    		 standard smoking cessation support only

    Serious adverse events
    		 preloading control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 899 (0.89%)
    8 / 893 (0.90%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    2
    2
    Investigations
    Aspiration pleural cavity
         subjects affected / exposed
    1 / 899 (0.11%)
    0 / 893 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 899 (0.00%)
    1 / 893 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    2 / 899 (0.22%)
    0 / 893 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hernia repair
         subjects affected / exposed
    0 / 899 (0.00%)
    1 / 893 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 899 (0.11%)
    0 / 893 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 899 (0.00%)
    1 / 893 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pneumonia
         subjects affected / exposed
    0 / 899 (0.00%)
    1 / 893 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 899 (0.11%)
    1 / 893 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 899 (0.00%)
    2 / 893 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    1 / 899 (0.11%)
    0 / 893 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    1 / 899 (0.11%)
    0 / 893 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Pyelonephritis
         subjects affected / exposed
    0 / 899 (0.00%)
    1 / 893 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pelvic fracture
         subjects affected / exposed
    1 / 899 (0.11%)
    0 / 893 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 preloading control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 899 (15.46%)
    85 / 893 (9.52%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    4 / 899 (0.44%)
    8 / 893 (0.90%)
         occurrences all number
    4
    8
    Nervous system disorders
    Abnormal dreams
         subjects affected / exposed
    9 / 899 (1.00%)
    1 / 893 (0.11%)
         occurrences all number
    9
    1
    Dizziness
         subjects affected / exposed
    15 / 899 (1.67%)
    6 / 893 (0.67%)
         occurrences all number
    15
    6
    Headache
         subjects affected / exposed
    14 / 899 (1.56%)
    3 / 893 (0.34%)
         occurrences all number
    14
    3
    Poor quality sleep
         subjects affected / exposed
    20 / 899 (2.22%)
    3 / 893 (0.34%)
         occurrences all number
    20
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 899 (1.11%)
    5 / 893 (0.56%)
         occurrences all number
    10
    5
    Fatigue
         subjects affected / exposed
    6 / 899 (0.67%)
    0 / 893 (0.00%)
         occurrences all number
    6
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 899 (0.67%)
    3 / 893 (0.34%)
         occurrences all number
    6
    3
    Diarrhoea
         subjects affected / exposed
    8 / 899 (0.89%)
    3 / 893 (0.34%)
         occurrences all number
    8
    3
    Nausea
         subjects affected / exposed
    30 / 899 (3.34%)
    8 / 893 (0.90%)
         occurrences all number
    30
    8
    Vomiting
         subjects affected / exposed
    14 / 899 (1.56%)
    3 / 893 (0.34%)
         occurrences all number
    14
    3
    Respiratory, thoracic and mediastinal disorders
    Infection
         subjects affected / exposed
    1 / 899 (0.11%)
    4 / 893 (0.45%)
         occurrences all number
    1
    4
    Influenza like illness
         subjects affected / exposed
    7 / 899 (0.78%)
    3 / 893 (0.34%)
         occurrences all number
    7
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 899 (0.44%)
    7 / 893 (0.78%)
         occurrences all number
    4
    7
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    5 / 899 (0.56%)
    2 / 893 (0.22%)
         occurrences all number
    5
    2
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    5 / 899 (0.56%)
    4 / 893 (0.45%)
         occurrences all number
    5
    4
    Musculoskeletal and connective tissue disorders
    Musculoskeletal disorder
         subjects affected / exposed
    10 / 899 (1.11%)
    7 / 893 (0.78%)
         occurrences all number
    10
    7

    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
    For support, Contact us.
    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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