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    Clinical Trial Results:
    The brain opioid system and emotional experiences arising while viewing social interactions.

    Summary
    EudraCT number
    		 2012-005278-71
    Trial protocol
    		 FI  
    Global end of trial date
    07 Oct 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    REMINALO1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinki University Hospital
    Sponsor organisation address
    Stenbäckinkatu, Helsinki, Finland, 00029 HUS
    Public contact
    Eija Kalso, Helsinki University Central Hospital, 358 9471 75640, eija.kalso@hus.fi
    Scientific contact
    Eija Kalso, Helsinki University Central Hospital, 358 9471 75885, eija.kalso@helsinki.fi
    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 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Tutkimuksessa selvitetään tunnesisällöltään negatiivisten, positiivisten ja neutraalien sosiaalisia vuorovaikutuksia vuorovaikutustilanteita esittäviä lyhyitä elokuvaleikkeiden vasteita terveille koehenkilöille samanaikaisesti kun he saavat yksittäissokkona laskimonsisäisesti infusoituna keittosuolaliosta, opioidia ja opioidi agonistia. The trial examines the emotional reactions to short film clips showing negative, positive and neutral social interactions during single blind infusions of remifentanil, saline and naloxone.
    Protection of trial subjects
    Helsinki University Hospital insurance
    Background therapy
    		 None, healthy volunteers
    Evidence for comparator
    		 None, experimental study.
    Actual start date of recruitment
    02 Jan 2013
    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
    Finland: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy male volunteers aged 18-45 years, no medications.

    Pre-assignment
    Screening details
    		 Examination by a neurologist: history, clinical examination, medications, allergies.

    Pre-assignment period milestones
    Number of subjects started
    		 31
    Number of subjects completed
    		 31

    Period 1
    Period 1 title
    remifentanil
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The healthy volunteer was unaware in which order the drugs were given (remifentanil, saline, naloxone)

    Arms
    Arm title
    		 remifentanil
    Arm description
    		 Remifentanil was administered at an effect-site concentration of 1 ng/ml using a target-controlled infusion pump.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ultiva
    Investigational medicinal product code
    N01AH06
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Remifentanil (Ultiva) was administered as an effect-site concentration of 1 ng/ml using a target-controlled infusion pump.

    Number of subjects in period 1
    		remifentanil
    Started
    31
    all three infusions during the same sess
    31
    Completed
    31
    Period 2
    Period 2 title
    saline
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The healthy volunteer was unaware of the order of the drugs (remifentanil or saline or naloxone)

    Arms
    Arm title
    		 saline
    Arm description
    		 saline was infused iv for 23 min after a 2 min bolus
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natrium chloride
    Investigational medicinal product code
    B05BB01
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Int5avenous infusion for 23 min

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Based on the study design (emotional valence and arousal while watching film clips), only Period 1 which is the period when saline was administered (and then compared with remifentanil or naloxone) can be considered as baseline.
    Number of subjects in period 2
    		saline
    Started
    31
    Completed
    31
    Period 3
    Period 3 title
    naloxone
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    the healthy volunteer was unaware of the order in which the drugs were administered

    Arms
    Arm title
    		 naloxone
    Arm description
    		 Naloxone was administered as a 5 micg/kg iv bolus followed by an infusion of 40 micg/kg/min for 23 min
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naloxone
    Investigational medicinal product code
    V03AB15
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Naloxone was administered as a 5 micg/kg iv bolus followed by an infusion of 40 micg/kg/min for 23 min

    Number of subjects in period 3
    		naloxone
    Started
    31
    Completed
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    saline
    Reporting group description
    		 -

    Reporting group values
    		 saline Total
    Number of subjects
    		 31 31
    Age categorical
    only males aged 20-35 participated in the study
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 31 31
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        adults
    		 0 0
    Age continuous
    age from 20 to35 years
    Units: years
        median (full range (min-max))
    		 30 (20 to 35) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 31 31
    Subject analysis sets

    Subject analysis set title
    healthy volunteers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    31 male healthy volunteers aged 20-35 years

    Subject analysis sets values
    		 healthy volunteers
    Number of subjects
    31
    Age categorical
    only males aged 20-35 participated in the study
    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)
    31
        From 65-84 years
    0
        85 years and over
    0
        adults
    31
    Age continuous
    age from 20 to35 years
    Units: years
        median (full range (min-max))
    30 (20 to 35)
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    31

    End points

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    End points reporting groups
    Reporting group title
    remifentanil
    Reporting group description
    		 Remifentanil was administered at an effect-site concentration of 1 ng/ml using a target-controlled infusion pump.
    Reporting group title
    saline
    Reporting group description
    		 saline was infused iv for 23 min after a 2 min bolus
    Reporting group title
    naloxone
    Reporting group description
    		 Naloxone was administered as a 5 micg/kg iv bolus followed by an infusion of 40 micg/kg/min for 23 min

    Subject analysis set title
    healthy volunteers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    31 male healthy volunteers aged 20-35 years

    Primary: valence at end of film clip

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    End point title
    		 valence at end of film clip
    End point description
    The valance of each film clip was assessed by the study subject. The valence (or arousal which was the opposite feeling) values were compared between the three infusion periods
    End point type
    Primary
    End point timeframe
    Valence was assessed at the end of each film clip
    End point values
    		 naloxone remifentanil saline
    Number of subjects analysed
    31
    31
    31
    Units: 0-1000
        arithmetic mean (standard error)
    420 ± 10
    455 ± 10
    405 ± 10
    Statistical analysis title
    		 clip-wise F2 analysis
    Comparison groups
    remifentanil v saline v naloxone
    Number of subjects included in analysis
    93
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 none
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the drug infusion and washout.
    Adverse event reporting additional description
    during remifentanil infusion, 4 individuals reported nausea and 5 sedation.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own questionnaire
    Dictionary version
    na
    Reporting groups
    Reporting group title
    remifentanil
    Reporting group description
    		 -

    Serious adverse events
    		 remifentanil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 remifentanil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 31 (29.03%)
    Nervous system disorders
    Sedation
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    5
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    4

    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.
    Our experimental study does not fit into this system.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31006490
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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