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    Clinical Trial Results:
    ACUTE AND LONG-TERM EFFECTS OF INTRANASAL OXYTOCIN IN ALCOHOL WITHDRAWAL AND DEPENDENCE: A PROSPECTIVE RANDOMIZED PARALLEL GROUP PLACEBO-CONTROLLED TRIAL

    Summary
    EudraCT number
    2015-004463-37
    Trial protocol
    NO  
    Global end of trial date
    30 Nov 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    140682
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02903251
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    St. Olavs University Hospital
    Sponsor organisation address
    St. Olavs hospital HF, Postboks 3250 Torgarden, Trondheim, Norway, 7006
    Public contact
    PI's representative(Katrine Melby), Lade Behandlingssenter, +47 92886639, katrine.melby@stolav.no
    Scientific contact
    PI's representative(Katrine Melby), Lade Behandlingssenter, 92886639 92886639, katrine.melby@stolav.no
    Sponsor organisation name
    St. Olavs University Hospital
    Sponsor organisation address
    Postboks 3250 Torgarden, Trondheim, Norway, 7006
    Public contact
    katrine.melby@stolav.no, Department of Clinical Pharmacology, St. Olavs Universtiy Hospital, +47 92886639, katrine.melby@stolav.no
    Scientific contact
    katrine.melby@stolav.no, Department of Clinical Pharmacology, St. Olavs Universtiy Hospital, +47 92886639, katrine.melby@stolav.no
    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
    30 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of the study is to test whether daily intranasal administration of oxytocin is more effective than placebo in decreasing the oxazepam dosages required to control withdrawal symptoms during a 3-day inpatient program of medical detoxification.
    Protection of trial subjects
    Treatment as usual, following the procedures for withdrawal symptoms of alcohol detoxification. Reporting of adverse effects. Clinical monitor. Limiting number and duration of clinical tests in the detoxification period.
    Background therapy
    Benzodiazepin-treatment as usual, following the CIWA-Ar protocol at the detoxification ward.
    Evidence for comparator
    Oxytocin nasal spray alliviated alcohol withdrawal symptoms in a pilot trial. The main purpose of this study was to try to replicate the study and findings.
    Actual start date of recruitment
    01 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    39
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 40 patients admitted for alcohol detoxification and withdrawal treatment at the Blue Cross Lade Addiction TreatmentCenter (LBS) in Trondheim, Norway. Eligible subjects were 18–65 years of age and lived in the county of Trøndelag, Norway. The inclusion period lasted from October 2016 to November 2017.

    Pre-assignment
    Screening details
    Assessed for eligibility n = 138. Did not meet inclusion criteria (n = 96) Daily treatment with benzodiazepines or benzodiazepine-like hypnotics (n = 33) Negative alcohol breath test and > 15 h since last intake (n = 28) All other criteria (n= 55) Invited to participate (n = 42). Declined to participate (n = 2)

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Oxytocin
    Arm description
    Subjects were given six insufflations of the nasal spray (containing a total dose of 24 IU oxytocin or placebo) in interchanging nostrils with 15 s in between insufflations, twice daily for 3 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Syntocinon
    Investigational medicinal product code
    Other name
    Oxytocin
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Subjects were given six insufflations of the nasal spray (containing a total dose of 24 IU oxytocin or placebo) in interchanging nostrils with 15 s in between insufflations. x 2 daily for 3 days.

    Arm title
    Placebo
    Arm description
    subjects were given six insufflations of the placebo nasal spray (containing placebo) in interchanging nostrils with 15 s in between insufflations twice daily for 3 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo spray containing the same constituents as Syntocinon, except oxytocin.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    subjects were given six insufflations of the placebo nasal spray (containing placebo) in interchanging nostrils with 15 s in between insufflations twice daily for 3 days.

    Number of subjects in period 1
    Oxytocin Placebo
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oxytocin
    Reporting group description
    Subjects were given six insufflations of the nasal spray (containing a total dose of 24 IU oxytocin or placebo) in interchanging nostrils with 15 s in between insufflations, twice daily for 3 days.

    Reporting group title
    Placebo
    Reporting group description
    subjects were given six insufflations of the placebo nasal spray (containing placebo) in interchanging nostrils with 15 s in between insufflations twice daily for 3 days.

    Reporting group values
    Oxytocin Placebo Total
    Number of subjects
    20 20 40
    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)
    48.9 ( 11.3 ) 46.6 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    7 4 11
        Male
    13 16 29
    Marital status
    Marital status: Single/Cohabiting
    Units: Subjects
        Single
    14 14 28
        Cohabiting
    6 6 12
    Employment
    Employment: Yes/No
    Units: Subjects
        Yes
    5 4 9
        No
    15 16 31
    Sel-reported daily alcohol intake during the last 14 days
    Units: standard alcohol units
        arithmetic mean (standard deviation)
    17.0 ( 8.0 ) 15.0 ( 6.4 ) -
    Phosphatidylethanol blood concentration at inclusion
    Units: μmol/L
        arithmetic mean (standard deviation)
    2.26 ( 1.12 ) 2.20 ( 1.22 ) -
    Total number of hours in the study
    Units: Hours
        arithmetic mean (standard deviation)
    53.4 ( 5.5 ) 52.4 ( 9.2 ) -
    Total number of nasal spray administration
    Units: Number of nasal sprays
        arithmetic mean (standard deviation)
    5.80 ( 0.41 ) 5.90 ( 0.31 ) -

    End points

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    End points reporting groups
    Reporting group title
    Oxytocin
    Reporting group description
    Subjects were given six insufflations of the nasal spray (containing a total dose of 24 IU oxytocin or placebo) in interchanging nostrils with 15 s in between insufflations, twice daily for 3 days.

    Reporting group title
    Placebo
    Reporting group description
    subjects were given six insufflations of the placebo nasal spray (containing placebo) in interchanging nostrils with 15 s in between insufflations twice daily for 3 days.

    Primary: Total oxazepam dosage in milligrams

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    End point title
    Total oxazepam dosage in milligrams
    End point description
    End point type
    Primary
    End point timeframe
    3 days of detoxification.
    End point values
    Oxytocin Placebo
    Number of subjects analysed
    20
    20
    Units: Mg
        arithmetic mean (standard deviation)
    56.8 ( 72.8 )
    79.0 ( 122.9 )
    Statistical analysis title
    Total oxazepam dose
    Comparison groups
    Placebo v Oxytocin
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.49
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -22.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -86.9
         upper limit
    42.4

    Secondary: CIWA-ar

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    End point title
    CIWA-ar
    End point description
    End point type
    Secondary
    End point timeframe
    3 days
    End point values
    Oxytocin Placebo
    Number of subjects analysed
    20
    20
    Units: Score, number
        arithmetic mean (standard deviation)
    5.94 ( 3.86 )
    6.48 ( 3.92 )
    Statistical analysis title
    CIWA-Ar score
    Comparison groups
    Oxytocin v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.665
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.03
         upper limit
    1.95
    Variability estimate
    Standard deviation

    Secondary: HSCL-10

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    End point title
    HSCL-10
    End point description
    End point type
    Secondary
    End point timeframe
    3 days
    End point values
    Oxytocin Placebo
    Number of subjects analysed
    19
    20
    Units: HSCL-score
        arithmetic mean (standard deviation)
    25.1 ( 5.6 )
    25.3 ( 7.3 )
    Statistical analysis title
    HSCL-10
    Comparison groups
    Placebo v Oxytocin
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.945
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.38
         upper limit
    4.09
    Variability estimate
    Standard deviation

    Secondary: Self-reported sleep

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    End point title
    Self-reported sleep
    End point description
    End point type
    Secondary
    End point timeframe
    3 days
    End point values
    Oxytocin Placebo
    Number of subjects analysed
    19
    20
    Units: hours
        arithmetic mean (standard deviation)
    5.28 ( 2.95 )
    5.92 ( 3.17 )
    Statistical analysis title
    Self-reported sleep
    Comparison groups
    Oxytocin v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.535
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.72
         upper limit
    1.44
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Oxytocin
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Oxytocin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (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: 1%
    Non-serious adverse events
    Oxytocin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    General disorders and administration site conditions
    Discomfort nose
    Additional description: Due to amount of nasal spray.
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0

    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.
    Large variability in mg oxazepam.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/30784955
    http://www.ncbi.nlm.nih.gov/pubmed/32053696
    http://www.ncbi.nlm.nih.gov/pubmed/33352584
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