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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    Feasibility, efficacy and acceptability of injected buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment

    Summary
    EudraCT number
    2011-001088-28
    Trial protocol
    GB  
    Global end of trial date
    10 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Apr 2020
    First version publication date
    23 Apr 2020
    Other versions
    Summary report(s)
    Cancelled Before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    BRIO
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    South London and Maudsley NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 8AZ
    Public contact
    Professor John Strang, South London and Maudsley NHS Foundation Trust, 0044 02078480819, john.strang@kcl.ac.uk
    Scientific contact
    Professor John Strang, South London and Maudsley NHS Foundation Trust, 0044 02078480819, john.strang@kcl.ac.uk
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Professor John Strang, King's College London, 44 02078480819, john.strang@kcl.ac.uk
    Scientific contact
    Professor John Strang, King's College London, 44 02078480819, john.strang@kcl.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
    10 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The trial aims to examine the safety, acceptability, and physiological responses to high dose injectable buprenorphine, for subjects not responding to their current maintenance treatment. The key outcomes are as follows: - Feasibility, of recruiting and maintaining subjects with a daily injection (IV/IM) of buprenorphine (successful retention outcome defined as 60+ %) - Reduction or cessation of injecting street heroin (successful outcome defined as 50% of urine tests negative for illicit heroin (i.e. morphine) in weeks 14-26) - Safety (of daily IV/IM injection of buprenorphine (assessed by observations of IMP administration, laboratory testing, cardio respiratory monitoring, and adverse events)
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Jan 2020
    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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial

    Pre-assignment
    Screening details
    N/A

    Period 1
    Period 1 title
    Whole trial period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    N/A open label

    Arms
    Arm title
    Injectable Buprenorphine
    Arm description
    Subjects will be inducted onto injectable buprenorphine according to the following regime: • Week 1- buprenorphine ampoules 3mg per day • Week 2- buprenorphine ampoules 6mg per day • Week 4- buprenorphine ampoules 9mg per day
    Arm type
    Experimental

    Investigational medicinal product name
    Temgesic
    Investigational medicinal product code
    Other name
    Buprenorphine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    9 mg milligram(s) per day

    Investigational medicinal product name
    Suboxone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    24 mg milligram(s) per day

    Number of subjects in period 1
    Injectable Buprenorphine
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole trial period
    Reporting group description
    -

    Reporting group values
    Whole trial period Total
    Number of subjects
    99999 99999
    Age categorical
    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)
    99999 99999
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    99999 99999
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Injectable Buprenorphine
    Reporting group description
    Subjects will be inducted onto injectable buprenorphine according to the following regime: • Week 1- buprenorphine ampoules 3mg per day • Week 2- buprenorphine ampoules 6mg per day • Week 4- buprenorphine ampoules 9mg per day

    Primary: feasibility, of recruiting and maintaining (successful retention outcome defined as 60+%) subjects with a daily injection (IV/IM) of buprenorphine

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    End point title
    feasibility, of recruiting and maintaining (successful retention outcome defined as 60+%) subjects with a daily injection (IV/IM) of buprenorphine [1]
    End point description
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    N/A
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this primary end point
    End point values
    Injectable Buprenorphine
    Number of subjects analysed
    99999 [2]
    Units: Number of subjects recruited
    99999
    Notes
    [2] - N/A
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    N/A
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects were enrolled in the trial hence results are not available

    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.
    No subjects were enrolled in the trial hence results are not available
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