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    Summary
    EudraCT Number:2013-002584-25
    Sponsor's Protocol Code Number:10/46/01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-002584-25
    A.3Full title of the trial
    Naltrexone Enhanced Addiction Treatment (NEAT): A randomised controlled trial of the clinical and cost-effectiveness of extended-release naltrexone and oral naltrexone.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Naltrexone Enhanced Addiction Treatment (NEAT): A randomised controlled trial of the clinical and cost-effectiveness
    of extended-release naltrexone and oral naltrexone
    A.3.2Name or abbreviated title of the trial where available
    Naltrexone Enhanced Addiction Treatment (NEAT)
    A.4.1Sponsor's protocol code number10/46/01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Health technology assessment
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Psychiatry, Psychology & Neuroscience (IoPPN)
    B.5.2Functional name of contact pointBlair McLennan, NEAT Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressAddiction Sciences Building, 4 Windsor Walk
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8BB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0207 848 5109
    B.5.6E-mailblair.mclennan@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Health Technology Assessment
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Psychiatry, Psychology & Neuroscience (IoPPN)
    B.5.2Functional name of contact pointBlair McLennan
    B.5.3 Address:
    B.5.3.1Street AddressAddiction Sciences Building, 4 Windsor Walk
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE58BB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44207848 5109
    B.5.6E-mailblair.mclennan@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Naltrexone Hydrochloride 50 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderOrpha-Devel Handels und Vertriebs GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNaltrexone Hydrochloride 50mg film-coated Tablets
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaltrexone Hydrochloride
    D.3.9.1CAS number 0016590-41-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNaltrexone (implant)
    D.3.4Pharmaceutical form Implantation tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaltrexone
    D.3.9.1CAS number 16590-41-3
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number765
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboImplantation tablet
    D.8.4Route of administration of the placeboImplantation
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Opiate addiction
    E.1.1.1Medical condition in easily understood language
    The NEAT trial is for individuals with heroin addiction that have been diagnosed in the past year, but are not currently taking Heroin and want help to stay away from heroin.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10019935
    E.1.2Term Heroin addiction
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A. Is XR-NTX treatment more effective than placebo at reducing heroin use?
    B. Is XR-NTX more effective than O-NTX at reducing heroin use?
    C. Is XR-NTX more cost- effective than placebo in terms of quality-adjusted life years?
    D. Is XR-NTX more cost-effective than O-NTX in terms of quality-adjusted life year?

    E.2.2Secondary objectives of the trial
    A. To compare treatment retention and medication and psychological intervention adherence rates among the XR-NTX, O-NTX and placebo conditions.
    B. To contrast the XR-NTX, O-NTX and placebo conditions on quality of life indices.
    C. To contrast XR-NTX, O-NTX and placebo conditions on:
     heroin and cocaine craving;
     self-reported opioid, cocaine, amphetamine and benzodiazepine use (with past 48 hour abstinence verified via urine drug screening [UDS]);
     alcohol use;
     injection health risk behaviours;
     psychological health (depression and anxiety symptoms);
     molecular (genetic) biomarkers of treatment response.
     Plasma naltrexone and 6-β-naltrexol (the primary metabolite of NTX);
    D. To document the safety of XR-NTX and O-NTX.
    E. To compare patterns of heroin relapse among the XR-NTX, O-NTX and placebo conditions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for the study are intended to be as close to clinical practice as possible. Each participant in the trial must meet all of the following criteria:
    1. Is 18 years of age or older.
    2. Can demonstrate a verbal understanding of the study patient information material, is able to provide written consent, and can understand and confirm willingness to comply with the protocol.
    3. Has a diagnosis of opioid use disorder based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5: past 12 months),) conducted at baseline.

    4. Is completing or has recently completed an inpatient or outpatient treatment for opioid detoxification, or has been completely and continuously abstinent from all opioids for at least seven days.
    5. Has no tolerance to opioids, as verified by a negative urine toxicology screening test prior to randomisation (using an instant result immunoassay device).
    6. Passes a naloxone challenge test (to confirm zero opioid tolerance by demonstrating no clinical sign or subjective report of opioid withdrawal before randomisation and prior to implant procedure) NB: Individuals failing screening will be allowed to enter screening as clinically indicated.
    7. Is voluntarily seeking opioid antagonist treatment for opioid use disorder.
    8. Lives in stable/secure accommodation in the community.
    9. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required.
    10. If female, is not pregnant or breast feeding and agrees to use a birth control method (either oral hormonal contraceptives, barrier [condom or diaphragm], or Nexplanon implant) for the duration of the study.
    E.4Principal exclusion criteria
    Otherwise eligible individuals who meet any of the following criteria will be excluded from the study:
    1. Clinically significant medical condition or observed abnormalities on physical examination or laboratory investigation, including but not limited to:
     Uncontrolled hypertension;
     Significant heart disease (including angina and myocardial infarction in past 12 months);
     Any ECG/cardiovascular abnormality which, in the investigator’s judgment, is clinically significant.
    2. Severe alcohol dependence and/or alcohol withdrawal (by clinical assessment).
    3. Opioid withdrawal syndrome, current.
    4. Positive test for presence of opioids in urine (i.e. indicating current opioid use) prior to randomisation (using an instant result immunoassay device).
    5. Clinical diagnosis of opioid dependence syndrome (F11.2) with current physical dependence such that an antagonist medication (e.g. naloxone, naltrexone) could precipitate a withdrawal syndrome
    6. Positive naloxone challenge test at randomization (confirming opioid use) or absence of a recorded result from a naloxone provocation test.
    7. Acute hepatitis taken as clinical jaundice on examination and/or blood bilirubin level >normal range for local reference criteria or aspartate aminotransferase or alanine aminotransferase (>3x the upper limit of the normal range).
    8. Hepatic insufficiency (taken as >3 times the upper limit of the normal range of aspartate aminotransferase or alanine aminotransferase)
    9. Severe renal impairment evaluated by clinical decision
    10. Known Icenko-Cushing syndrome or to require investigation if suspected Cushingoid features/symptoms
    11. Systemic mycoses
    12. Clinical history of glaucoma
    13. Clinical history of osteoporosis
    14. pregnancy, or positive or unclear test result from pregnancy test, or intention to try to become pregnant during the study period, or is sexually active without using a birth control method (either oral hormonal contraceptives, barrier [condom or diaphragm], or Nexplanon implant) for the duration of the trial.
    15. Currently breast-feeding
    16. History of hypersensitivity to opioid receptor blockers (naloxone and naltrexone
    formulations) and other components of the formulation.
    17. History of hypersensitivity to triamcinolone or related compounds
    18. Currently taking oral or depot naltrexone therapy or enrolment in any form of naltrexone therapy within 90 days prior to study screening, apart from treatment given by trial team between screening and randomisation.
    19. Current criminal justice involvement with legal proceedings (not including current probation supervision) and, in the opinion of the clinical worker, is expected to fail to complete the study protocol due to re-incarceration or relocation from the centre’s catchment area.
    20. Current (past 30 day) suicidal planning, or recent (past six months) suicide attempt.
    21. Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder) and/or a history or evidence of organic brain disease or dementia that would compromise the participant’s ability to comply with the study protocol.
    22. Current participation in any interventional trial, or completed participation in any interventional trial (which in the view of the chief investigator might interfere with the NEAT trial) within the last 3 months
    E.5 End points
    E.5.1Primary end point(s)
    Clinical: the proportion of heroin negative UDS results at the end of the 12 week post-randomisation period (denominator 36), with contrasts for: (i)XR-NTX vs. placebo, and (ii) XR-NTX vs. O-NTX.
    Economic: health related quality of life and cost-effectiveness at 36 weeks with comparisons for (i) XR-NTX vs. placebo, and (ii) XR-NTX vs, O-NTX.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks post-randomisation for clinical outcome and 12 weeks and 36 weeks follow up for the health economic outcomes.
    E.5.2Secondary end point(s)
    Treatment retention, adherence, heroin and cocaine craving scores, self-reported opioid, cocaine, benzodiazepine (and their active class metabolites via urine drug screening), and alcohol use, injection health risk behaviours, psychological health (depression and anxiety symptoms), and health-related quality of life results over the 12 weeks from randomisation and at 16, 24 and 36 week follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks from randomisation and at 16, 24 and 36 week follow-up.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Expected clinical participation for each participant is from consent until the final follow-up at 36 weeks (38 weeks in total). The study will begin when the first participant gives consent and will end when the last participant has finished the follow up assessment at 36 weeks.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the 12 weeks of trial treatment, participants will be free to continue to receive keyworker facilitated case management support as normal. After each participant has completed their six month follow-up, we will offer six months of O-NTX to all patients who are eligible and wish to receive it, and we will continue to recommend attendance at self-help group meetings and other local recovery support options. Continued NTX treatment after this will reflect local NHS policy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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