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    Clinical Trial Results:
    Effects of Varenicline and Cognitive Bias Modification on Neural Response to Smoking Cues

    Summary
    EudraCT number
    		 2011-004169-34
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2018
    First version publication date
    28 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UoB1407
    Additional study identifiers
    ISRCTN number
    		 ISRCTN65690030
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Funder-Pfizer: WS676950
    Sponsors
    Sponsor organisation name
    University of Bristol
    Sponsor organisation address
    Senate House, Tyndall Avenue, Bristol, United Kingdom, BS8 1TH
    Public contact
    Dr Birgit Whitman, University of Bristol, Research Enterprise and Development, +44 01173317130, Birgit.Whitman@bristol.ac.uk
    Scientific contact
    Dr Birgit Whitman, University of Bristol, Research Enterprise and Development, +44 01173317130, Birgit.Whitman@bristol.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
    11 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) Does cognitive bias modification alter neural response to smoking-related cues? H1a: We hypothesise that experimental procedures designed to induce attentional bias towards smoking-relates cues will lead to an increase in neural response to smoking-related cues, in brain regions previously implicated in cue reactivity in cigarette smokers. H1b: We hypothesise that experimental procedures designed to induce attentional bias away from smoking-relates cues will lead to a decrease in neural response to smoking-related cues, in brain regions previously implicated in cue reactivity in cigarette smokers.
    Protection of trial subjects
    The study medication was a licensed medication to aid smoking cessation, and no serious adverse events were expected. The drug (varenicline) is associated with some side effects which were explained to the participant who was told they were able to stop the study medication at any time. The more common side effects may be unpleasant but are not considered serious or long lasting (e.g., fatigue, vivid dreams, nausea). There is some weak scientific evidence to suggest a small increase in cardiovascular events for participants taking varenicline compared to placebo. The research has been criticised methodologically but to mitigate any risk we included an upper age limit of 40 years (the mean ages of participants in studies in the meta analysis in question was 39 - 57). There is also association of the drug with depressive symptoms. To mitigate risk participants were screened by a psychiatrist prior to enrolment.
    Background therapy
    		 None
    Evidence for comparator
    		 N/a
    Actual start date of recruitment
    01 Nov 2011
    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: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    89
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from the Bristol area (south west United Kingdom). All participants were current smokers (i.e., at least 10 manufactured or 15 roll-up cigarettes per day). The first participant was enrolled on 5th November 2011 and the last participant was enrolled on 24th June 2014.

    Pre-assignment
    Screening details
    		 Inclusion: aged 18-40 Exclusion: pregnancy/breastfeeding, drug misuse disorder, psychiatric illness, clinically significant abnormality (including CV risk), ongoing medication, uncorrected visual/auditory impairment, hypersensitivity to varenciline, cannot have MRI scan. Exclusion breakdown information no longer available.

    Pre-assignment period milestones
    Number of subjects started
    		 312 [1]
    Number of subjects completed
    		 89

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not eligible or lost contact: 223
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment phase is a screening phase in which potential participants were screened for eligibility. This occurred before enrollment and therefore the number is higher than those enrolled.
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Baseline measurements taken on all participants prior to randomisation to drug and CBM experimental conditions

    Arms
    Arm title
    		 Baseline
    Arm description
    		 Baseline testing (pre-randomization)
    Arm type
    		 Baseline

    Investigational medicinal product name
    None
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Wound stick
    Routes of administration
    Other use
    Dosage and administration details
    No product given in this stage. Above (pharmaceutical forms) added as was mandatory, but not relevant here.

    Number of subjects in period 1
    		Baseline
    Started
    89
    Completed
    89
    Period 2
    Period 2 title
    Drug regime (7 days)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Varenicline or matched placebo was prescribed for one week, to be taken as 0.5 mg once daily for days 1 - 3, and 0.5 mg twice daily for days 4 - 6, and 0.5 mg once daily for day 7. Drugs were were dispatched from Bristol Royal Infirmary Pharmacy, who randomised drug to participant numbers. Pharmacy provided drug bottles pre-labelled with blinded condition allocation, and a unblinding sheet for study file

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Varenicline
    Arm description
    		 Active drug condition
    Arm type
    		 Experimental

    Investigational medicinal product name
    Varenicline
    Investigational medicinal product code
    CP526-555
    Other name
    Champix, Chantix
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Varenicline was administered for one week, to be taken as 0.5 mg once daily for days 1 - 3, and 0.5 mg twice daily for days 4 - 6, and 0.5 mg once daily for day 7, consistent with early standard dosing regimen for smoking cessation. Smoking cessation usage usually extends beyond a single week however (depending on need of patient).

    Arm title
    		 Placebo
    Arm description
    		 Control drug (matched placebo to varenicline)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matched to active drug

    Number of subjects in period 2
    		Varenicline Placebo
    Started
    46
    43
    Completed
    44
    41
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    1
    Period 3
    Period 3 title
    Cognitive bias modification
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Participants were andomly assigned to CBM groups, but equal numbers of participants per group were maintained, and groups were balanced for sex and drug condition. In advance of the study, an experimental collaborator prepared a numeric code using random number assignment software.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CBM Avoid
    Arm description
    		 Cognitive bias modification that trained participants to avoid smoking related cues
    Arm type
    		 Experimental

    Investigational medicinal product name
    CBM Avoidance training (computer-based task)
    Investigational medicinal product code
    n/a
    Other name
    Pharmaceutical forms
    Wound stick
    Routes of administration
    Other use
    Dosage and administration details
    Pharmaceutical form (wound stick) is wrong. Entry was mandatory but not relevant. This product is an active version of a computer based cognitive bias training programme. This version trains smokers to attend away (i.e., avoid) smoking-related cues.

    Arm title
    		 CBM Neutral
    Arm description
    		 Control task with no active training
    Arm type
    		 Placebo

    Investigational medicinal product name
    CBM Neutral (computer based task)
    Investigational medicinal product code
    n/a
    Other name
    Pharmaceutical forms
    Wound stick
    Routes of administration
    Other use
    Dosage and administration details
    Pharmaceutical form (wound stick) is wrong. Entry was mandatory but not relevant. This product is a the control version of a computer based cognitive bias training programme.

    Arm title
    		 CBM Attend
    Arm description
    		 Cognitive bias training that trained participants to attend to smoking related cues
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CBM Attend (computer-based task)
    Investigational medicinal product code
    n/a
    Other name
    Pharmaceutical forms
    Wound stick
    Routes of administration
    Other use
    Dosage and administration details
    Pharmaceutical form (wound stick) is wrong. Entry was mandatory but not relevant. This product is an active version of a computer based cognitive bias training programme. This version trains smokers to attend towards (i.e., attend) smoking-related cues.

    Number of subjects in period 3
    		CBM Avoid CBM Neutral CBM Attend
    Started
    38
    23
    24
    Completed
    22
    22
    24
    Not completed
    16
    1
    0
         Computer task failed to record
    -
    1
    -
         Computer error
    16
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Baseline characteristics for all subjects in final analysis (n = 68), excluding withdrawals (n = 4) and participants who had to be replaced due to computer error (n=17).

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 89 89
    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
    Units: years
        arithmetic mean (standard deviation)
    		 23 ( 5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 48 48
    Smoking heaviness
    Units: Cigarettes per day
        arithmetic mean (standard deviation)
    		 15 ( 3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Baseline testing (pre-randomization)
    Reporting group title
    Varenicline
    Reporting group description
    		 Active drug condition

    Reporting group title
    Placebo
    Reporting group description
    		 Control drug (matched placebo to varenicline)
    Reporting group title
    CBM Avoid
    Reporting group description
    		 Cognitive bias modification that trained participants to avoid smoking related cues

    Reporting group title
    CBM Neutral
    Reporting group description
    		 Control task with no active training

    Reporting group title
    CBM Attend
    Reporting group description
    		 Cognitive bias training that trained participants to attend to smoking related cues

    Subject analysis set title
    Varenicline / CBM Avoid
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received varenciline and completed CBM training to avoid to smoking cues

    Subject analysis set title
    Varenicline / CBM Attend
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received varenciline and completed CBM training to attend to smoking cues

    Subject analysis set title
    Varenicline / CBM control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received varenciline and completed CBM control task (no training)

    Subject analysis set title
    Placebo / CBM attend
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received placebo and completed CBM training to attend to smoking cues

    Subject analysis set title
    Placebo / CBM avoid
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received placebo and completed CBM training to avoid to smoking cues

    Subject analysis set title
    Placebo / CBM control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received placebo and completed CBM control task (i.e., no training)

    Primary: Neural response to smoking cues

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    End point title
    		 Neural response to smoking cues
    End point description
    End point type
    Primary
    End point timeframe
    One measure after 7-day drug regime and immediately after CBM
    End point values
    		 Varenicline / CBM Avoid Varenicline / CBM Attend Varenicline / CBM control Placebo / CBM attend Placebo / CBM avoid Placebo / CBM control
    Number of subjects analysed
    12
    10 [1]
    10
    12
    10
    11 [2]
    Units: % BOLD signal
        number (not applicable)
    -0.003
    0.092
    0.057
    0.139
    0.038
    0.222
    Notes
    [1] - Two participants were removed from the analysis due to poor quality images
    [2] - One participant were removed from the analysis due to poor quality images
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    A 2 (varenicline, placebo) × 3 (attend, avoid, control) mixed-model whole-brain ANOVA was used to examine smoking cue reactivity (smoking greater than control) between each group
    Comparison groups
    Varenicline / CBM Avoid v Varenicline / CBM Attend v Varenicline / CBM control v Placebo / CBM attend v Placebo / CBM avoid v Placebo / CBM control
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Confidence interval

    Primary: Stroop Time 2 (Generalised Attentional Bias post drug, pre CBM)

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    End point title
    		 Stroop Time 2 (Generalised Attentional Bias post drug, pre CBM)
    End point description
    A pictorial version of the modified Stroop task was used to investigate the effect of dot-probe CBM on a different measure of cognitive bias. The task began with 16 practice trials followed by two experimental blocks, each comprising 8 buffer and 96 experimental trials (i.e., 208 trials in total). For each trial a picture was presented (smoking-related or neutral) centrally on screen. The picture was surrounded by a coloured border and the participant was required to identify the colour of the border (red, blue, yellow or green) using colour-marked keys on the keyboard. Error scores are bias scores calculated by subtracting the number of errors made to neutral images from the number of errors made to smoking images) - thus positive scores are indicative of smoking attentional bias. Note on outliers: For error data, three participants were identified as outliers in the pre-CBM condition and one in the post-CBM condition. These data were removed from analyses.
    End point type
    Primary
    End point timeframe
    This measure of attentional bias was taken on day 7 (i.e., after varenicline treatment), but before CBM training.
    End point values
    		 Varenicline Placebo
    Number of subjects analysed
    33 [3]
    31 [4]
    Units: Errors (bias)
        arithmetic mean (standard deviation)
    0.13 ( 1.91 )
    -0.45 ( 1.87 )
    Notes
    [3] - One outlier removed
    [4] - Three outliers removed
    Statistical analysis title
    		 Stroop by drug group
    Statistical analysis description
    Test of attentional bias following 7 day drug regime. This Univariate ANOVA comprised one between-subjects factor of drug: varenicline/placebo.
    Comparison groups
    Varenicline v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.22
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 0.81
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34

    Secondary: Stroop Time 3 (Generalised attentional bias post drug and training)

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    End point title
    		 Stroop Time 3 (Generalised attentional bias post drug and training)
    End point description
    A pictorial version of the modified Stroop task was used to investigate the effect of dot-probe CBM on a different measure of cognitive bias. The task began with 16 practice trials followed by two experimental blocks, each comprising 8 buffer and 96 experimental trials (i.e., 208 trials in total). For each trial a picture was presented (smoking-related or neutral) centrally on screen. The picture was surrounded by a coloured border and the participant was required to identify the colour of the border (red, blue, yellow or green) using colour-marked keys on the keyboard. Error scores are bias scores calculated by subtracting the number of errors made to neutral images from the number of errors made to smoking images) - thus positive scores are indicative of smoking attentional bias. Note on outliers: For error data, three participants were identified as outliers in the pre-CBM condition and one in the post-CBM condition. These data were removed from analyses.
    End point type
    Secondary
    End point timeframe
    This measure of attentional bias was taken on day 7 (i.e., after varenicline treatment and CBM training)
    End point values
    		 CBM Avoid CBM Neutral CBM Attend Varenicline / CBM Avoid Varenicline / CBM Attend Varenicline / CBM control Placebo / CBM attend Placebo / CBM avoid Placebo / CBM control
    Number of subjects analysed
    19 [5]
    22 [6]
    22 [7]
    10
    10
    10
    11
    9
    12
    Units: Errors (Bias)
        arithmetic mean (standard deviation)
    -1.16 ( 2.29 )
    -0.95 ( 1.91 )
    -0.09 ( 1.82 )
    -1.2 ( 2.97 )
    -1.18 ( 1.47 )
    -1.0 ( 2.30 )
    1.0 ( 1.48 )
    -1.11 ( 1.36 )
    -0.92 ( 1.62 )
    Notes
    [5] - Outliers removed
    [6] - Outliers removed
    [7] - Outliers removed
    Statistical analysis title
    		 Stroop by CBM group (post training)
    Comparison groups
    CBM Avoid v CBM Neutral v CBM Attend
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.194
    Method
    		 ANOVA
    Parameter type
    		 Slope
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.099
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.428
    Statistical analysis title
    		 Stroop: Drug by CBM
    Comparison groups
    Varenicline / CBM Avoid v Varenicline / CBM Attend v Varenicline / CBM control v Placebo / CBM attend v Placebo / CBM avoid v Placebo / CBM control
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.134
    Method
    		 ANOVA
    Parameter type
    		 Slope
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.23
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.614

    Secondary: Visual dot probe 2 (Attentional bias)

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    End point title
    		 Visual dot probe 2 (Attentional bias)
    End point description
    Each trial began with a fixation cross (500 ms), before a picture pair (smoking image, neutral image) was presented on a computer screen. The picture pair stayed on screen for 500 ms and then was replaced by a probe (small square or circle) in a location previously occupied by one of the pictures. Participants were required to identity whether the probe was a square or circle by pressing designated keyboard keys. There were 128 test with the probe appearing with equal frequency in the location of the smoking-related or neutral picture. The inter-trial interval jittered between 750 ms and 1,250 ms. To create a reaction time bias score, RTs to smoking images were subtracted from RT to neutral images. Thus positive RT scores are indicative of a smoking attentional bias.
    End point type
    Secondary
    End point timeframe
    This measure of attentional bias was taken on day 7 (i.e., after varenicline treatment), but before CBM training.
    End point values
    		 Varenicline Placebo
    Number of subjects analysed
    34
    34
    Units: Reaction Time Bias (ms)
        arithmetic mean (standard deviation)
    11.97 ( 37.76 )
    -1.76 ( 29.38 )
    Statistical analysis title
    		 VDP after varenicline treatment
    Comparison groups
    Varenicline v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.099
    Method
    		 ANOVA
    Parameter type
    		 Slope
    Point estimate
    11.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.387
         upper limit
    		 23.552
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.801

    Secondary: Visual Dot Probe 3 - Attentional bias

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    End point title
    		 Visual Dot Probe 3 - Attentional bias
    End point description
    Each trial began with a fixation cross (500 ms), before a picture pair (smoking image, neutral image) was presented on a computer screen. The picture pair stayed on screen for 500 ms and then was replaced by a probe (small square or circle) in a location previously occupied by one of the pictures. Participants were required to identity whether the probe was a square or circle by pressing designated keyboard keys. There were 128 test with the probe appearing with equal frequency in the location of the smoking-related or neutral picture. The inter-trial interval jittered between 750 ms and 1,250 ms. To calculate a reaction time bias score, reaction time to smoking images was subtracted from reaction time to neutral images. Thus positive reaction time scores are indicative of smoking attentional bias. Due to computer malfunction, post-training CBM data were not recorded for one participant, therefore post-training sample comprises 67 participants.
    End point type
    Secondary
    End point timeframe
    This measure of attentional bias was taken on day 7 (i.e., after varenicline treatment and CBM training).
    End point values
    		 CBM Avoid CBM Neutral CBM Attend Varenicline / CBM Avoid Varenicline / CBM Attend Varenicline / CBM control Placebo / CBM attend Placebo / CBM avoid Placebo / CBM control
    Number of subjects analysed
    22
    22
    23
    12
    10
    10
    12
    10
    12
    Units: Reaction time bias (ms)
        arithmetic mean (standard deviation)
    -1.63 ( 18.34 )
    -9.32 ( 29.14 )
    11.75 ( 45.07 )
    -1.79 ( 15.16 )
    15.42 ( 48.29 )
    -8.36 ( 40.22 )
    8.39 ( 43.78 )
    -1.45 ( 22.45 )
    -10.12 ( 17.22 )
    Statistical analysis title
    		 VDP after CBM treatment
    Comparison groups
    CBM Avoid v CBM Neutral v CBM Attend
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.103
    Method
    		 ANOVA
    Parameter type
    		 Slope
    Point estimate
    -9.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.36
         upper limit
    		 4.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.03
    Statistical analysis title
    		 VDP by CBM and varenicline treatment
    Comparison groups
    Varenicline / CBM Avoid v Varenicline / CBM Attend v Varenicline / CBM control v Placebo / CBM attend v Placebo / CBM avoid v Placebo / CBM control
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.931
    Method
    		 ANOVA
    Parameter type
    		 Slope
    Point estimate
    -8.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.67
         upper limit
    		 12.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.66

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Data collection period from November 2011 to July 2014
    Adverse event reporting additional description
    Participants were given reporting cards to log any AEs. These were collected by the researcher on day 7 (final day) of drug regime. Participants were advised to contact the researcher during the drug regime if they were concerned about side effects, or were experiencing unexpected or severe side effects.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Champix CDS
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Varenicline group
    Reporting group description
    		 Participants allocated to varenicline medication for 7 days.

    Reporting group title
    Placebo group
    Reporting group description
    		 Individuals in control arm who were administered 7 days placebo treatment

    Serious adverse events
    		 Varenicline group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Varenicline group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 46 (43.48%)
    18 / 43 (41.86%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    3 / 46 (6.52%)
    4 / 43 (9.30%)
         occurrences all number
    3
    4
    Tiredness/drowsiness
         subjects affected / exposed
    2 / 46 (4.35%)
    7 / 43 (16.28%)
         occurrences all number
    2
    7
    Vivid dreams / disrupted sleep
         subjects affected / exposed
    7 / 46 (15.22%)
    1 / 43 (2.33%)
         occurrences all number
    7
    1
    Thirst/dry mouth
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Cigarettes tasted bad
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Fainting
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Eye disorders
    Eye twitch
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea, vomiting, stomach cramps
         subjects affected / exposed
    8 / 46 (17.39%)
    4 / 43 (9.30%)
         occurrences all number
    8
    4
    General
    Additional description: Includes diarrhea, constipation, heartburn
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Appetite loss
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety/agitation
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Mood changes
    Additional description: Low mood / mood swings
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Infections and infestations
    Cold symptoms
    Additional description: Includes runny nose, sore throat, cough
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2012
    Correction of description of drug vehicle in study documentation from capsule to tablet. Inclusion criteria regarding cannabis use was relaxed to aid recruitment.
    24 Jun 2013
    A structural scan was originally scheduled for baseline session (week one). This was moved to the test session (week two) when there was a function scan. This negated the need to book the scanner twice.
    05 Feb 2014
    17 participants had to be replaced (new participants recruited) due to computer error

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Dec 2011
    After original target was met and data were extracted, we found that computer data had failed to record for one condition. We therefore had to replace 17 participants who did not complete their allocated training appropriately. There was an interruption to testing in order for us to obtain ethics approval (amendment) to continue and to receive more drug.
    18 Mar 2014

    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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