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Clinical trials for Suboxone

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Suboxone. Displaying page 1 of 1.
    EudraCT Number: 2021-001817-35 Sponsor Protocol Number: 111958 Start Date*: 2021-08-04
    Sponsor Name:Radboud University Medical Center
    Full Title: Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial.
    Medical condition: Opioid use disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-005235-14 Sponsor Protocol Number: P05042 Start Date*: 2007-07-11
    Sponsor Name:Integrated Therapeutics Group Inc
    Full Title: A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users
    Medical condition: Opioid dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013663 Drug dependence LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) ES (Completed) CZ (Completed) PT (Completed) SI (Completed) DE (Completed) IE (Completed) IT (Completed) LT (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2009-012814-36 Sponsor Protocol Number: HDL09-01 Start Date*: 2009-09-23
    Sponsor Name:Helsingin Diakonissalaitos
    Full Title: Buprenorfiini-naloksoni ja metadoni erilaisissa psykososiaalisissa hoito-ohjelmissa buprenorfiiniriippuvaisten korvaushoidossa. Satunnaistettu kontrolloitu tutkimus
    Medical condition: Opioidiriippuvuus, buptenorfiinin suonensisäinen väärinkäyttö
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030893 Opioid type dependence, continuous use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006686-17 Sponsor Protocol Number: P05094 Start Date*: 2007-04-25
    Sponsor Name:Schering-Plough
    Full Title: Evaluation of preference for a buprenorphine-based maintenance therapy, after a switch from buprenorphine alone (Subutex®) to the buprenorphine/naloxone combination (Suboxone®), in opioid-dependent...
    Medical condition: For both compounds, substitution treatment for opiod drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intrav...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-003047-22 Sponsor Protocol Number: RB-UK-11-0017 Start Date*: 2012-01-12
    Sponsor Name:Reckitt Benckiser Pharmaceuticals
    Full Title: A Randomised, Double-Blind, Double-Dummy, Active-Drug-Controlled, Parallel-Group, Multicentre Acceptability and Safety Study of the Transfer from Subutex®/Suboxone® to RBP-6300 in Opioid-Dependent ...
    Medical condition: Maintenance/substitution agent for the treatment of opioid dependence
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10012346 Dependence on opiates LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) CZ (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002237-11 Sponsor Protocol Number: ARC Start Date*: 2012-12-17
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: Effectiveness of Adaptive Opioid Agonist Maintenance Pharmacotherapy and Behavioural Therapy for Opioid Use Disorder.
    Medical condition: Opiate dependency disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-005234-21 Sponsor Protocol Number: P04843 Start Date*: 2007-11-28
    Sponsor Name:Schering-Plough Research Institute
    Full Title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.
    Medical condition: Opioid dependance
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013663 Drug dependence LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) SE (Completed) PT (Completed) DK (Completed) LT (Completed) SI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002352-41 Sponsor Protocol Number: HDL07-01 Start Date*: 2007-08-21
    Sponsor Name:Helsingin Diakonissalaitos
    Full Title: Lyhyt ja pitkä buprenorfiini-naloksoni -hoito suonensisäisen buprenorfiiniriippuvuuden vieroitushoidossa. Satunnaistettu kontrolloitu tutkimus
    Medical condition: Opiaattiriippuvuus, buprenorfiinin suonensisäinen väärinkäyttö
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030882 Opiate withdrawal symptoms LLT
    9.1 10064475 Opiate dependency relapse LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-010360-41 Sponsor Protocol Number: BU0902 Start Date*: 2009-06-03
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Limited
    Full Title: A multicentre, randomised, open-label, active-controlled trial of the effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in France
    Medical condition: For both compounds, substitution treatment for opioid drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intra...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012346 Dependence on opiates LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-016079-32 Sponsor Protocol Number: AS Start Date*: 2010-12-02
    Sponsor Name:Universitätsklinik für Psychiatrie - Spezialambulanz für Abhangigkeitserkrankungen
    Full Title: Auswirkungen der Substitutionstherapie mit Methadon und Buprenorphin auf die kognitiven Funktionen.
    Medical condition: Untersuchung der kognitiven Leistungsfähigkeit bei Opiatabhängigen, die sich in der Substitutionstherapie unter Methadon und unter Buprenorphin befinden.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-002714-22 Sponsor Protocol Number: 7108 Start Date*: 2008-08-28
    Sponsor Name:Medizinische Universität Innsbruck - Institut für gerichtliche Medizin
    Full Title: UNTERSUCHUNG DER GENETISCH BEDINGTEN VARIABILITÄT DES OPIOID- UND OPIATBEDARFS IM RAHMEN DES DROGENSUBSTITUTIONSPROGRAMMS und HÄUFIGKEITEN GENETISCHER POLYMORPHISMEN BEI POPULATIONEN MIT UND OHNE O...
    Medical condition: Untersuchung des Einflusses genetischer Faktoren auf die Variabilität des Opioid- und Opiatbedarfs von opioidabhängige Personen in Behandlungsprogrammen in Österreich, die langwirksamen Opioide bzw...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063747 Therapeutic response unexpected with drug substitution LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2022-003925-23 Sponsor Protocol Number: PIANISSIMO Start Date*: 2023-04-12
    Sponsor Name:Vrije Universiteit Brussel
    Full Title: Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation.
    Medical condition: Persistent spinal pain syndrome type 2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-002229-23 Sponsor Protocol Number: RB-UK-11-0018 Start Date*: 2012-05-09
    Sponsor Name:RB Pharmaceuticals Inc.
    Full Title: A randomised, double blind, placebo controlled, cross over study of the effects of Buprenorphine Hemiadipate Hydrochloride/Naloxone Hydrochloride Dihydrate intravenous challenges in opioid dependen...
    Medical condition: Maintenance/substitution agent for the treatment of opioid dependence.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002440-13 Sponsor Protocol Number: OMT-Satisfaction Start Date*: 2015-12-15
    Sponsor Name:Medical University Innsbruck
    Full Title: Treatment satisfaction and self-reported symptoms in patients under opioid maintenance therapy
    Medical condition: Opioid maintenance treatment (OMT) is an important factor in the medical care of opioid-dependent patients. Qualified OMT combined with general medical care and psychosocial support is effective in...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004460-63 Sponsor Protocol Number: EXPO Start Date*: 2019-07-01
    Sponsor Name:South London and Maudsley NHS Foundation Trust [...]
    1. South London and Maudsley NHS Foundation Trust
    2. King's College London
    Full Title: Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO): An Open Label Randomised Controlled Trial of Injectable Depot Maintenance Buprenorphine versus Standard-Of-Care Oral Maintenance Opi...
    Medical condition: Opiod addiction
    Disease: Version SOC Term Classification Code Term Level
    23.1 10037175 - Psychiatric disorders 10013658 Drug addiction LLT
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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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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