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Clinical trials for Naltrexone

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    44 result(s) found for: Naltrexone. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2011-002181-20 Sponsor Protocol Number: NTX2010-2-0130 Start Date*: 2011-12-29
    Sponsor Name:Oslo University Hospital [...]
    1. Oslo University Hospital
    2. Oslo University Hospital
    Full Title: Naltrexone Implants for Alcoholism
    Medical condition: Alcohol dependence in outpatients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10001640 Alcoholism (excl psychosis) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002972-26 Sponsor Protocol Number: LDN_7323 Start Date*: 2015-12-14
    Sponsor Name:Smerteklinikken
    Full Title: Low dose naltrexone for treatment of pain in patients with fibromyalgia - effect via central mechanism? A randomized, double-blinded, placebo-controlled, cross-over study
    Medical condition: Pain in patients with fibromylagia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-002859-42 Sponsor Protocol Number: OPNT002-AUD-001 Start Date*: 2020-01-28
    Sponsor Name:Opiant Pharmaceuticals Inc
    Full Title: Randomised, double-blind, placebo-controlled trial evaluating the effects of naltrexone hydrochloride nasal spray on alcohol consumption in Alcohol Use Disorder
    Medical condition: Alcohol use Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.1 10037175 - Psychiatric disorders 10080021 Alcohol use disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed)
    Trial results: View results
    EudraCT Number: 2009-013647-10 Sponsor Protocol Number: 2P50-DA012756-11 Start Date*: 2009-12-10
    Sponsor Name:National Institute on Drug Abuse (NIDA)
    Full Title: Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
    Medical condition: Amphetamine dependence
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IS (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-021384-33 Sponsor Protocol Number: NTXMR1 Start Date*: 2010-08-20
    Sponsor Name:Beroendecentrum Stockholm
    Full Title: The Effect of Naltrexone on Amphetamine Cue Reactivity: An fMRI Study
    Medical condition: Amphetamine dependence
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001049-15 Sponsor Protocol Number: HD-TREX Start Date*: 2018-08-24
    Sponsor Name:ANOVA (Andrologi, Sexualmedicin, Transmedicin) Karolinska Universitetssjukhuset och Umeå Universitet
    Full Title: Pharmacological treatment of hypersexual disorder; an open pilot study to evaluate the feasibility and effectiveness of treatment with Naltrexone
    Medical condition: Hypersexual disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10066364 Hypersexuality PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002831-16 Sponsor Protocol Number: TUD-TEMANX-065 Start Date*: 2015-10-20
    Sponsor Name:Technische Universität Dresden
    Full Title: Validation of a test system for development of medications for alcoholism
    Medical condition: male and female volunteers aged 25-55 years with moderate risky alcohol consumption of at least 41 g/day (men) or 31 g/day (women), according to European Medicines Agency (EMA, 2010) this is at lea...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004869 10049180 Alcohol product use HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    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: 2008-004102-14 Sponsor Protocol Number: 8123 Start Date*: 2008-10-23
    Sponsor Name:Kansanterveyslaitos
    Full Title: Rahapeliriippuvuuden hoitaminen kohdennetulla naltreksonilääkityksellä ja oppimismallilla
    Medical condition: Peliriippuvuus, muuten terveitä
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017657 Gambling pathological LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-005679-13 Sponsor Protocol Number: NALTREX005 Start Date*: 2006-06-28
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis.
    Medical condition: multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10053395 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002081-31 Sponsor Protocol Number: 16008 Start Date*: 2016-11-17
    Sponsor Name:Anæstesiologisk-intensiv afd V, Odense Universitets Hospital
    Full Title: Investigation of dose response relationships when using low dose naltrexone (LDN) for the treatment of fibromyalgia
    Medical condition: Fibromyalgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10016631 Fibromyalgia syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2006-000837-36 Sponsor Protocol Number: 20060123 Start Date*: 2006-06-07
    Sponsor Name:Beroendecentrum Stockholm
    Full Title: Effect of Naltrexone on cue-induced craving for Amphetamine in amphetamine dependent individuals
    Medical condition: Amphetamine dependence
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012461-54 Sponsor Protocol Number: MSE001 Start Date*: 2011-04-26
    Sponsor Name:Sörmlands läns landsting
    Full Title: Långverkande opioidantagonistbehandling för opioidberoende patienter, effekter på missbruk och kriminalitet Treatment of opioid dependency with long acting opioid antagonist, effect on the substanc...
    Medical condition: Opioidberoende
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000702-30 Sponsor Protocol Number: 18.021 Start Date*: 2019-10-30
    Sponsor Name:Odense University Hospital
    Full Title: Fibromyalgia and Naltrexone: The FINAL study
    Medical condition: Fibromyalgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10048439 Fibromyalgia PT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-004710-95 Sponsor Protocol Number: REPAS161118 Start Date*: 2018-02-07
    Sponsor Name:Beroendecentrum Stockholm
    Full Title: Extended-release injectable suspension naltrexone (XR-NTX) as an adjunt pharmacotherapy for prevention of substance use in patients with SUD who are currently in treatment for ADHD: A multicenter r...
    Medical condition: Amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity Disorder)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-000852-32 Sponsor Protocol Number: 80-84800-98-82002 Start Date*: 2020-01-30
    Sponsor Name:ErasmusMC
    Full Title: A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.
    Medical condition: Inflammatory Bowel Disease, Crohn's disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004255-36 Sponsor Protocol Number: Cesar Start Date*: 2020-10-05
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: Cesar - an open, randomized controlled phase II study, comparing Naltrexon and Fluoxetin treating Compulsive Sexual Behavior Disorder.
    Medical condition: Compulsive Sexual Behavior Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000245-33 Sponsor Protocol Number: VN21 Start Date*: 2022-05-31
    Sponsor Name:Medical University of Lublin
    Full Title: To evaluate the effect of low-dose naltrexone (LDN) on pain perception and quality of life in women
    Medical condition: Vulvodynia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10047781 Vulvodynia LLT
    Population Age: Adults Gender: Female
    Trial protocol: PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006886-18 Sponsor Protocol Number: ALK21-014 Start Date*: 2007-06-04
    Sponsor Name:Alkermes Inc
    Full Title: Efficacy and Safety of Vivitrol® in Adults Completing Inpatient Treatment for Alcohol Dependence
    Medical condition: Alcohol Dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001590 Alcohol addiction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002145-15 Sponsor Protocol Number: NOK0023 Start Date*: 2023-10-31
    Sponsor Name:Nederlandse Obesitas Kliniek
    Full Title: Applying Mysimba in patients with weight regain after bariatric surgery
    Medical condition: Weight regain post bariatric surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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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