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    Clinical Trial Results:
    The effect of Tetrahydrocannabinol on ocular hemodynamics in healthy subjects

    Summary
    EudraCT number
    		 2017-004852-52
    Trial protocol
    		 AT  
    Global end of trial date
    27 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPHT-141117
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna , Austria,
    Public contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
    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
    27 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and its regulation.
    Protection of trial subjects
    Subjects were during the trial continuously under the supervision of an physician or an experienced nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 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
    Austria: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited using the data base of the clinical pharmacology, medical university of Vienna.

    Pre-assignment
    Screening details
    		 Check of the in- and exclusion criteria, physical examination, vital signs, laboratory assessment

    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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Medication
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dronabinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5mg once

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule identical in appearance to Dronabinol capsules without an active ingredient. Placebo will also be taken together 15g butter, 2 pieces of bread and 250ml of water.

    Number of subjects in period 1
    		Medication Placebo
    Started
    25
    25
    Completed
    24
    24
    Not completed
    1
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 25 25
    Age categorical
    Men and women aged between 18 and 35 years
    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)
    		 25 25
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Medication
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: The effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and

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    End point title
    		 The effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and
    End point description
    End point type
    Primary
    End point timeframe
    one hour after drug administration
    End point values
    		 Medication Placebo
    Number of subjects analysed
    24
    24
    Units: arbitrary units
    24
    24
    Statistical analysis title
    		 Statistics to end point
    Comparison groups
    Medication v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Cox proportional hazard
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    02.07.2018-27.11.2018
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Adverse events overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse events overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    Immune system disorders
    Urticaria
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2018
    Changed surname study nurse (wedding)

    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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    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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