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    Clinical Trial Results:
    Improving GHB withdrawal with baclofen (The GHB Trial)

    Summary
    EudraCT number
    		 2013-005319-28
    Trial protocol
    		 GB  
    Global end of trial date
    28 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2018
    First version publication date
    13 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNWL/AL/BACL/01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN59911189
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Central and North West London NHS Foundation Trust
    Sponsor organisation address
    1st Floor, Bloomsbury Building, St Pancras Hospital, 4 St Pancras Way, London, United Kingdom, NW1 0PE
    Public contact
    Angela Williams , Central and North West London NHS Foundation Trust, baclofen.noclor@nhs.net
    Scientific contact
    Angela Williams , Central and North West London NHS Foundation Trust, baclofen.noclor@nhs.net
    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
    13 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Feasibility of a full scale RCT
    Protection of trial subjects
    The study was conducted within ethical and regulatory framework. We acknowledged that the patient would have to spend some time with the researcher answering questions about how they feel, their medical and psychiatric history and having blood samples taken. To minimise any inconvenience and if face to face interviews were not possible or required, particularly at followup, participants were called. Whilst the risk from baclofen is minimal from our clinical experience, it was only given during benzodiazepine prescription and monitoring during detox. Whilst it can be safely prescribed to a wide range of people and is associated with few side-effects, we monitored those with some conditions as described in the SPC
    Background therapy
    		 Benzodiazepine (diazepam)
    Evidence for comparator
    		 GHB acts at GABAB receptors and therefore the GABAB agonist baclofen has been used on an unlicensed named patient basis as an adjunct to benzodiazepines to manage GHB/GBL withdrawal. Baclofen is currently only licensed in the UK for the management of muscle spasticity eg in multiple sclerosis. An uncontrolled case series in 19 GHB/GBL dependent patients, reported that baclofen (10mg tds) in addition to high dose diazepam during the initial 4–5 days of GHB/GBL detoxification, resulted in no transfers to ICU and several patients commented that baclofen was helpful. Additional clinical experience is that baclofen is helpful in reducing the complications from GHB/GBL withdrawal. Therefore is it is suggested that baclofen (10mg tds) be used as an adjunct to benzodiazepines for GHB/GBL withdrawal. In addition our clinical experience is that starting baclofen two days before commencing medically assisted detoxification is helpful with anxiety and cravings as well as stabilising GHB use. Clinical experience is that baclofen is associated with few side-effects. Whilst a withdrawal state is recognised for baclofen, this is unlikely to occur with its use in acute GHB withdrawal due to the short duration (7-10 days) of baclofen use in this indication. We suggest that the risk of complications from baclofen withdrawal is considerably less than that of inadequately managed GHB/GBL withdrawal. Nevertheless, whilst use of baclofen holds promise, there are potential adverse effects on cardiovascular, neurological and respiratory systems so controlled data is urgently required to determine the efficacy and safety of baclofen in GHB/GBL withdrawal. Optimising outpatient treatment to reduce the risk of complications and hospital admission is important since many individuals decline admission. Despite this complexity and its impact on and cost to the individual and NHS, there is limited knowledge about how to best treat people in planned or unplanned GHB/GBL withdrawal.
    Actual start date of recruitment
    02 Sep 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
    United Kingdom: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Individuals dependent on GHB requiring planned outpatient (Club Drug Clinic, CNWL) or unplanned inpatient detox (A&E, GSTT) were recruited between September 2016 to January 2017 (last participant recruited December 2016).

    Pre-assignment
    Screening details
    		 Participants were screened by telephone or in person regarding inclusion/exclusion criteria. Key: >18 years old who is either in active withdrawal or has underlying GHB/GBL dependence and wishes to undergo GHB/GBL detoxification or is thought to have underlying dependence and is at risk of acute withdrawal and able to take baclofen.

    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, Data analyst, Carer, Assessor
    Blinding implementation details
    Study medication looked the same ie baclofen and placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Planned A
    Arm description
    		 baclofen 10mg tds for 2 days then: benzodiazepine + baclofen 10mg tds
    Arm type
    		 Baclofen+baclofen

    Investigational medicinal product name
    baclofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    baclofen 10mg tds p.o.

    Arm title
    		 Planned B
    Arm description
    		 placebo tds for 2 days then: benzodiazepine + baclofen 10mg tds during detoxification
    Arm type
    		 placebo + active

    Investigational medicinal product name
    baclofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    baclofen 10mg tds p.o.

    Arm title
    		 Unplanned A
    Arm description
    		 benzodiazepine + baclofen 10mg tds during detox
    Arm type
    		 Active comparator

    Investigational medicinal product name
    baclofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    baclofen 10mg tds p.o.

    Number of subjects in period 1
    		Planned A Planned B Unplanned A
    Started
    2
    4
    1
    Completed
    0
    2
    1
    Not completed
    2
    2
    0
         Physician decision
    1
    -
    -
         Adverse event, non-fatal
    -
    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
    		 7 7
    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)
    		 7 7
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Planned A
    Reporting group description
    		 baclofen 10mg tds for 2 days then: benzodiazepine + baclofen 10mg tds

    Reporting group title
    Planned B
    Reporting group description
    		 placebo tds for 2 days then: benzodiazepine + baclofen 10mg tds during detoxification

    Reporting group title
    Unplanned A
    Reporting group description
    		 benzodiazepine + baclofen 10mg tds during detox

    Primary: Recruitment

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    End point title
    		 Recruitment [1]
    End point description
    Recruitment number
    End point type
    Primary
    End point timeframe
    Whole feasibility study
    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: This was a feasibility study with recruitment as a primary end point; the trial was terminated early and there is no statistical analysis.
    End point values
    		 Planned A Planned B Unplanned A
    Number of subjects analysed
    2 [2]
    4 [3]
    1 [4]
    Units: people
    2
    4
    1
    Notes
    [2] - 2 people recruited and randomised to this arm
    [3] - number recruited and randomised to this arm
    [4] - number recruited and randomised to this arm
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    Planned A
    Reporting group description
    		 baclofen 10mg tds for 2 days then: benzodiazepine + baclofen 10mg tds

    Reporting group title
    Planned B
    Reporting group description
    		 placebo tds for 2 days then: benzodiazepine + baclofen 10mg tds during detoxification

    Reporting group title
    Unplanned A
    Reporting group description
    		 benzodiazepine + baclofen 10mg tds during detox

    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 non-serious adverse events were reported in the total of 7 participants recruited
    Serious adverse events
    		 Planned A Planned B Unplanned A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Planned A Planned B Unplanned A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Sep 2015
    inclusion criteria: Drug services will assess the whole needs of the individual and work in partnership with other services to ensure that drug and alcohol use is seen in the context of agreed aftercare plan and the complexity of participant’s lives. Revised sample size: Due to issues regarding IMP and funding envelope available, our sample size was reduced for unplanned detoxification group only (Medical Toxicology, St. Thomas’s Hospital, London site) from 40 patients to 28 patients (14 patients in each arm). The planned group recruited from CNWL Club Drug Clinic site remains at 60. Weekend assessment: For planned detoxification group at CNWL Club Drug Clinic, we initially proposed that two of the assessments, CIWA-Ar and Sedation Assessment Tool, will only be completed during weekday clinic visits and not during weekends. However, we will give two printed copies of these assessments to our participants on Friday (Day 5 of detox) so they can complete them each day at home during the weekend and bring them back on Monday(Day 8 of Detoxification). This will enable us to collect robust data for the entire detox period including weekend. Focus groups to individual interviews for participants. Weekly follow-up contact via telephone.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Jan 2017
    Recruitment was halted to review the overall risk- benefit relationship of continuing the trial. The study did not re-start.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This was a feasibility study that terminated early. The primary objective was to look at recruitment to inform a main RCT. The study was not powered to compare treatment arms . No statistical analysis was conducted.
    For support, Contact us.
    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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