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    Clinical Trial Results:
    Randomised, double-blind, placebo controlled trial evaluating the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa

    Summary
    EudraCT number
    		 2016-003107-65
    Trial protocol
    		 GB  
    Global end of trial date
    02 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2020
    First version publication date
    17 Feb 2020
    Other versions
    Summary report(s)
    		 OPNT001-BN-001 Summary CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    OPNT001-BN-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Opiant Pharmaceuticals Inc
    Sponsor organisation address
    233 Wilshire Blvd., Suite 280, Santa Monica, United States, CA90401
    Public contact
    Opiant Pharmaceutcials Development, Opiant Pharmaceuticals UK Ltd, 0044 2034023098, jherry@opiant.com
    Scientific contact
    Opiant Pharmaceutcials Development, Opiant Pharmaceuticals UK Ltd, 0044 2034023098, jherry@opiant.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
    02 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if treatment with naloxone hydrochloride nasal spray reduces the binging behaviour in bulimia nervosa.
    Protection of trial subjects
    Study was conducted in compliance with ICH GCP and relevant data protection regulations. Research Ethics committee favourable option was obtained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 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
    United Kingdom: 86
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    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)
    86
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient’s first visit in the study (first patient screened) was on 26th April 2017, the first patient was randomised/treated on 17th May 2017. The last patient was randomised 28th August 2018. The recruitment period was 16 months. All patients were recruited in the UK.

    Pre-assignment
    Screening details
    		 Eligibility criteria were reviewed at a screening visit. Subjects were also asked to complete a daily diary about their condition for two weeks.

    Period 1
    Period 1 title
    Treatment (overall) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    The nasal spray bottles were identified by a unique numerical code and were otherwise identical. Sites issued the lowest available bottle number to the patients as they were randomised. The site team and monitors had no way to know the contents of the nasal spray.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Treatment Naloxone Hydrochloride 40mg/ml nasal spray
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naloxone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Naloxone hydrochloride was dosed at 4mg (one spray of 0.1ml of the 40mg/ml formulation in one nostril) once daily as needed plus one additional dose as needed at least 2 hours after the first dose in response to a binging urge (within 24 hours from 6am each day). At baseline and the Week 8 visits, subjects self-administered one dose at the visit.

    Arm title
    		 Placebo
    Arm description
    		 Treatment with placebo nasal spray
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    One dose (one spray of 0.1ml of the placebo formulation) in one nostril once daily as needed plus one additional dose as needed at least 2 hours after the first dose in response to a binging urge (within 24 hours from 6am each day). At baseline and the Week 8 visits, subjects self-administered one dose at the visit.

    Number of subjects in period 1
    		Active Placebo
    Started
    44
    42
    Completed
    31
    29
    Not completed
    13
    13
         Consent withdrawn by subject
    8
    4
         Physician decision
    -
    1
         Non specific
    -
    2
         Adverse event, non-fatal
    1
    2
         Lost to follow-up
    2
    4
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Treatment Naloxone Hydrochloride 40mg/ml nasal spray

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with placebo nasal spray

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 44 42 86
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 44 42 86
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 44 42 86
        Male
    		 0 0 0
    Race
    Units: Subjects
        Asian
    		 1 2 3
        White
    		 42 38 80
        Other
    		 1 1 2
        Multiple
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 42 42 84
        Unknown
    		 1 0 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 165.8 ± 6.7 166.6 ± 6.2 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 71.28 ± 19.26 70.9 ± 20.93 -
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 25.89 ± 6.81 25.15 ± 6.69 -

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Treatment Naloxone Hydrochloride 40mg/ml nasal spray

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with placebo nasal spray

    Primary: Binging Days from Baseline to Week 8

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    End point title
    		 Binging Days from Baseline to Week 8
    End point description
    End point type
    Primary
    End point timeframe
    The 2 weeks prior to Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Days
        arithmetic mean (standard deviation)
    14.8 ± 13.8
    13.8 ± 12.9
    Statistical analysis title
    		 Comparison of number of binging days from baseline
    Statistical analysis description
    Treatment group comparison of number of binging days from baseline to Week 8 imputing missing eDiary days using moving averages (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7756
    Method
    		 generalized estimating equation
    Parameter type
    		 Likelihood Ratio
    Point estimate
    0.957
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.706
         upper limit
    		 1.297

    Secondary: Number of binging episodes from baseline to Week 8

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    End point title
    		 Number of binging episodes from baseline to Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    The 2 weeks prior to Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Binging episodes
        arithmetic mean (standard deviation)
    36.7 ± 123.8
    18.9 ± 20.6
    Statistical analysis title
    		 Comparison of number of binging episodes
    Statistical analysis description
    Treatment group comparison of number of binging episodes from baseline to Week 8 (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8431
    Method
    		 Generalised Estimating Equations
    Parameter type
    		 Likelihood Ratio
    Point estimate
    0.964
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.674
         upper limit
    		 1.381

    Secondary: Purging behaviour at Week 8

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    End point title
    		 Purging behaviour at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    The two weeks prior to Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Purging Episodes
        arithmetic mean (standard deviation)
    35.4 ± 122.5
    25.6 ± 26.6
    Statistical analysis title
    		 Comparison of number of purging episodes
    Statistical analysis description
    Treatment group comparison of number of purging episodes from baseline to Week 8 (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0452
    Method
    		 negative binomial model
    Parameter type
    		 Likelihood Ratio
    Point estimate
    0.674
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.458
         upper limit
    		 0.992

    Secondary: Total number of calories in the taste test at Week 8

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    End point title
    		 Total number of calories in the taste test at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    The two weeks prior to Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Calories
        arithmetic mean (standard deviation)
    395.72 ± 299.3
    341.05 ± 375.96
    Statistical analysis title
    		 Total number of calories - Week 8
    Statistical analysis description
    Treatment group comparison of total number of calories in the taste test at Week 8 (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7191
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.77

    Secondary: Total number of calories in the taste test at baseline

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    End point title
    		 Total number of calories in the taste test at baseline
    End point description
    End point type
    Secondary
    End point timeframe
    The two weeks prior to Baseline
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Calories
        arithmetic mean (standard deviation)
    392.39 ± 348.08
    309.24 ± 264.92
    Statistical analysis title
    		 Total number of calories - Baseline
    Statistical analysis description
    Treatment group comparison of total number of calories in the taste test at baseline (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.699
    Method
    		 ANOVA
    Parameter type
    		 Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.73

    Secondary: Eating disorder questionnaire (EDE-Q) at Week 8

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    End point title
    		 Eating disorder questionnaire (EDE-Q) at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Score
        arithmetic mean (standard deviation)
    4.0 ± 1.2
    3.7 ± 1.3
    Statistical analysis title
    		 Comparison of eating disorder questionnaire
    Statistical analysis description
    Treatment group comparison of eating disorder questionnaire (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2108
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 0.22

    Secondary: Visual analogue scale (VAS) on mood at Week 8

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    End point title
    		 Visual analogue scale (VAS) on mood at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Score
        arithmetic mean (standard deviation)
    0.05 ± 14.3
    -0.76 ± 15.26
    Statistical analysis title
    		 VAS mood difference
    Statistical analysis description
    Treatment group comparison of VAS mood difference before and after dosing (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0197
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    8.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.33
         upper limit
    		 14.76

    Secondary: Visual analogue scale (VAS) on craving at Week 8

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    End point title
    		 Visual analogue scale (VAS) on craving at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    28
    Units: Score
        arithmetic mean (standard deviation)
    -3.39 ± 31.90
    2.07 ± 22.73
    Statistical analysis title
    		 VAS craving difference
    Statistical analysis description
    Treatment group comparison of VAS craving difference before and after dosing (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8306
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    -1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.38
         upper limit
    		 12.4

    Secondary: Visual analogue scale (VAS) on hunger at Week 8

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    End point title
    		 Visual analogue scale (VAS) on hunger at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    28
    Units: Score
        arithmetic mean (standard deviation)
    11.68 ± 25.65
    -5.75 ± 20.14
    Statistical analysis title
    		 VAS hunger difference
    Statistical analysis description
    Treatment group comparison of VAS difference before and after dosing (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.357
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    -5.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.92
         upper limit
    		 6.57

    Secondary: Visual analogue scale (VAS) on anxiety at Week 8

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    End point title
    		 Visual analogue scale (VAS) on anxiety at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    28
    Units: Score
        arithmetic mean (standard deviation)
    2.13 ± 20.43
    -0.54 ± 19.49
    Statistical analysis title
    		 VAS anxiety difference
    Statistical analysis description
    Treatment group comparison of VAS anxiety difference before and after dosing (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2037
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    5.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 14.2

    Secondary: Visual analogue scale (VAS) purging at Week 8

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    End point title
    		 Visual analogue scale (VAS) purging at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    28
    Units: Score
        arithmetic mean (standard deviation)
    5.1 ± 16.54
    10.82 ± 26.24
    Statistical analysis title
    		 VAS purging difference
    Statistical analysis description
    Treatment group comparison of VAS purging difference before and after dosing (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.886
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.33
         upper limit
    		 8.95

    Secondary: Visual analogue scale (VAS) on feeling full at Week 8

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    End point title
    		 Visual analogue scale (VAS) on feeling full at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    28
    Units: Score
        arithmetic mean (standard deviation)
    15.77 ± 30.96
    10.18 ± 31.54
    Statistical analysis title
    		 VAS feeling full
    Statistical analysis description
    Treatment group comparison of VAS feeling full difference before and after dosing (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4943
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    5.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.74
         upper limit
    		 21.98

    Secondary: Food craving questionnaire (FCQ) at Week 8

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    End point title
    		 Food craving questionnaire (FCQ) at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    27
    Units: Score
        arithmetic mean (standard deviation)
    151.4 ± 27.4
    157.7 ± 31.4
    Statistical analysis title
    		 Comparison of food craving questionnaire
    Statistical analysis description
    Treatment group comparison of food craving questionnaire (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2077
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    -9.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.18
         upper limit
    		 5.6

    Secondary: Abstinence of binging at Week 8 for at least a 2-week period

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    End point title
    		 Abstinence of binging at Week 8 for at least a 2-week period
    End point description
    End point type
    Secondary
    End point timeframe
    At week 8
    End point values
    		 Active Placebo
    Number of subjects analysed
    31
    29
    Units: Subjects
        Yes
    7
    8
        No
    24
    21
    Statistical analysis title
    		 Comparison of abstinence of binging at Week 8
    Statistical analysis description
    Treatment group comparison of abstinence of binging at Week 8 for at least a two weeks period. Only subjects who have performed Week 8 visit (ITT analysis set)
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.784
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.845
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.253
         upper limit
    		 2.823

    Other pre-specified: Treatment emergent adverse events (event)

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    End point title
    		 Treatment emergent adverse events (event)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From informed consent until end of study
    End point values
    		 Active Placebo
    Number of subjects analysed
    44
    42
    Units: Events
    188
    131
    No statistical analyses for this end point

    Other pre-specified: Treatment Emergent Adverse Events (Subject)

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    End point title
    		 Treatment Emergent Adverse Events (Subject)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From informed consent until end of study
    End point values
    		 Active Placebo
    Number of subjects analysed
    44
    42
    Units: Subjects
    37
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Emergent Adverse Events (From Baseline until Week 10 follow-up)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Treatment Naloxone Hydrochloride 40mg/ml nasal spray

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment with placebo nasal spray

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Mood altered
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (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: 5%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 44 (84.09%)
    38 / 42 (90.48%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 44 (29.55%)
    11 / 42 (26.19%)
         occurrences all number
    16
    14
    Dizziness
         subjects affected / exposed
    5 / 44 (11.36%)
    6 / 42 (14.29%)
         occurrences all number
    5
    6
    Dysgeusia
         subjects affected / exposed
    5 / 44 (11.36%)
    0 / 42 (0.00%)
         occurrences all number
    5
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 44 (11.36%)
    3 / 42 (7.14%)
         occurrences all number
    9
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    11 / 44 (25.00%)
    6 / 42 (14.29%)
         occurrences all number
    14
    8
    Diarrhoea
         subjects affected / exposed
    3 / 44 (6.82%)
    4 / 42 (9.52%)
         occurrences all number
    3
    4
    Abdominal pain
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    5 / 44 (11.36%)
    3 / 42 (7.14%)
         occurrences all number
    5
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 42 (11.90%)
         occurrences all number
    5
    6
    Nasal inflammation
         subjects affected / exposed
    7 / 44 (15.91%)
    0 / 42 (0.00%)
         occurrences all number
    9
    0
    Rhinalgia
         subjects affected / exposed
    4 / 44 (9.09%)
    3 / 42 (7.14%)
         occurrences all number
    4
    3
    Epistaxis
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 42 (2.38%)
         occurrences all number
    4
    1
    Nasal congestion
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 42 (4.76%)
         occurrences all number
    3
    2
    Nasal discomfort
         subjects affected / exposed
    6 / 44 (13.64%)
    0 / 42 (0.00%)
         occurrences all number
    6
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 44 (9.09%)
    5 / 42 (11.90%)
         occurrences all number
    6
    5
    Depressed mood
         subjects affected / exposed
    7 / 44 (15.91%)
    2 / 42 (4.76%)
         occurrences all number
    8
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 42 (11.90%)
         occurrences all number
    5
    5
    Gastroenteritis
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    3
    Rhinitis
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    Product issues
    Product taste abnormal
         subjects affected / exposed
    7 / 44 (15.91%)
    1 / 42 (2.38%)
         occurrences all number
    7
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 42 (2.38%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2017
    Updated exclusion criteria: Addition of other behavioural therapies besides CBT in the exclusion criteria ... Removal of exclusion of > 5 cigarettes a day to removed recruitment barrier … Addition of morning diary to ensure overnight activity isn’t missed … Addition of timing of taste test. … Addition of post dosing VAS and post dosing nasal mucosa exam when IMP is likely to have optimal effect … Addition of IMP priming to ensure accurate dosing … Removal of the sustained attention to response test (SART) and the balloon analogue risk task (BART), to improve patient visit time … Removal of taste test from screening as not necessary
    24 Nov 2017
    Update of exclusion criteria to include all antidepressant treatments besides fluoxetine and to increase the alcohol intake limit from 21 units per week to 32 units per week. Updated patient eDiary to permit recording of AE and concomitant medications

    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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