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Clinical trials for Opiate Addiction AND Drug Dependence

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    18 result(s) found for: Opiate Addiction AND Drug Dependence. Displaying page 1 of 1.
    EudraCT Number: 2007-001216-23 Sponsor Protocol Number: Clockstop 1, Start Date*: 2007-06-20
    Sponsor Name:Phoenux AG
    Full Title: Phase I Studie bei substituirten chronischen Opiatgebrauchern zur Aufhebung zusätzlicher Opioidwirkungen einer weiteren Opiatgebrauchern zur Aufhebung zusätlicher Opioidwirkungen einer weiteren Opi...
    Medical condition: Opiate addiction
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019935 Heroin addiction LLT
    Population Age: Adults Gender: Male
    Trial protocol: AT (Completed)
    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: 2011-001088-28 Sponsor Protocol Number: BRIO Start Date*: 2016-01-14
    Sponsor Name:South London and Maudsley NHS Foundation Trust [...]
    1. South London and Maudsley NHS Foundation Trust
    2. King's College London
    Full Title: Feasibility, efficacy and acceptability of injected buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment
    Medical condition: Addiction to illicit heroin
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10019935 Heroin addiction LLT
    18.1 100000004873 10001127 Addiction to drugs LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004912-30 Sponsor Protocol Number: aprepitant1 Start Date*: 2008-07-31
    Sponsor Name:Karolinska Institutet
    Full Title: Modulation of opiate reward by NK1 antagonism: A laboratory based proof of concept study
    Medical condition: opiate abuse
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039004 Reversal of opiate activity LLT
    9.1 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002708-26 Sponsor Protocol Number: CRC341 Start Date*: 2017-06-28
    Sponsor Name:University of Surrey
    Full Title: A randomised double blind placebo controlled pilot trial of oxytocin efficacy in treating detoxified opioid dependent individuals
    Medical condition: Opioid dependence. The study will be investigating the efficacy of Syntocinon (oxytocin) on treating the withdrawal symptoms and cravings that opioid (e.g. almost always heroin) dependent individua...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10057379 Addiction relapse LLT
    20.0 100000004873 10001126 Addiction any drug LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-006523-12 Sponsor Protocol Number: 19521952 Start Date*: 2009-08-12
    Sponsor Name:Julio Bobes
    Full Title: Mejora de la efectividad de los tratamientos de mantenimiento con naltrexona en adictos a opiáceos con la adicción de buprenorfina sublingual. Improvement of naltrexone maintenance treatment effec...
    Medical condition: Dependencia de opiáceos. Opiate dependence.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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: 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: 2008-002185-60 Sponsor Protocol Number: SUB9001 Start Date*: 2009-07-09
    Sponsor Name:Mundipharma Medical Company, Basel
    Full Title: RANDOMISED, CONTROLLED CLINICAL STUDY REGARDING THE FEASIBILITY OF CONVERTING OPIATE DEPENDENTS FROM METHADONE SUBSTITUTES TO SLOW RELEASE MORPHINE SULPHATE (SEVRE-LONG®)
    Medical condition: Patients with an opioid or multiple substance dependence (including opioids), actually enrolled in a methadone maintenance therapy in one of the study centres (ICD classifications F11.22, F19.22).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052970 Drug withdrawal maintenance therapy LLT
    9.1 10052730 Drug withdrawal therapies HLT
    9.1 10043413 Therapeutic procedures and supportive care NEC HLGT
    9.1 10012346 Dependence on opiates LLT
    9.1 10013663 Drug dependence LLT
    9.1 10064465 Substance-related disorders HLT
    9.1 10037176 Psychiatric disorders NEC HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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: 2015-003035-35 Sponsor Protocol Number: HS-14-499 Start Date*: 2015-11-09
    Sponsor Name:Braeburn Pharmaceuticals
    Full Title: An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioi...
    Medical condition: Opioid Use Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DK (Completed) HU (Completed)
    Trial results: View results
    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: 2012-002408-42 Sponsor Protocol Number: RB-UK-12-0004 Start Date*: 2012-11-29
    Sponsor Name:Reckitt Benckiser Pharmaceuticals Inc.
    Full Title: An Open-label, Randomised, Three -Way, Cross-Over Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Formulations of RBP-6300 10mg in Healthy Volunteers under a Naltrexone Block i...
    Medical condition: Maintenance/substitution agent for the treatment of opioid dependence.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10012346 Dependence on opiates LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002584-25 Sponsor Protocol Number: 10/46/01 Start Date*: 2014-11-06
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: Naltrexone Enhanced Addiction Treatment (NEAT): A randomised controlled trial of the clinical and cost-effectiveness of extended-release naltrexone and oral naltrexone.
    Medical condition: Opiate addiction
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10019935 Heroin addiction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004775-36 Sponsor Protocol Number: DETOX-11 Start Date*: 2012-01-30
    Sponsor Name:GET SRL
    Full Title: ''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms d...
    Medical condition: Oppiate addicts(heroin, methadone and buprenorphine)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10032707 Other specified drug dependence, continuous use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004482-41 Sponsor Protocol Number: SUB3001 Start Date*: 2006-04-07
    Sponsor Name:Napp Pharmaceuticals Research Limited
    Full Title: A randomised, double blind, double-dummy, parallel group study to compare the efficacy and tolerability of morphine sulphate prolonged release capsules and methadone oral solution in once per day a...
    Medical condition: Subjects have a diagnosis of opiate addiction.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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: 2008-005028-10 Sponsor Protocol Number: FARM7PER7 Start Date*: 2008-10-14
    Sponsor Name:Universita' di Firenze; Dipartimento di Farmacologia Preclinica e Clinica
    Full Title: Methadone dose adjustments, plasma R-methadone levels and therapeutic outcome of opioid addiction
    Medical condition: Heroin dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029205 Nervous system disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    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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