Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004706-18
    Sponsor's Protocol Code Number:269864
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-29
    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 ConcernedNorway - NOMA
    A.2EudraCT number2017-004706-18
    A.3Full title of the trial
    Long acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery (NaltRec)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery
    A.4.1Sponsor's protocol code number269864
    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 SponsorAkershus University Hospital
    B.1.3.4CountryNorway
    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 supportNorwegian Research Council
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportAkershus University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportHaukeland University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportSørlandet Hospital Trust
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportVestfold Hospital Trust
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportOslo University Hospital Trust
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkershus University Hospital
    B.5.2Functional name of contact pointDivision Mental Health Services
    B.5.3 Address:
    B.5.3.1Street AddressSykehusveien 25
    B.5.3.2Town/ cityLørenskog
    B.5.3.3Post code1478
    B.5.3.4CountryNorway
    B.5.4Telephone number004767968869
    B.5.6E-maillars.tanum@ahus.no
    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 Vivitrol
    D.2.1.1.2Name of the Marketing Authorisation holderAlkermes, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameVivitrol (Extended-release naltrexone hydrochloride for extended-release injectable suspension)
    D.3.2Product code N07BB04
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 CodeSUB09143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number380
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Opioid addiction
    E.1.1.1Medical condition in easily understood language
    Addiction to heroin and other opioids
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Additional main objective during the study
    5. To measure physiological and behavioural responses to stimuli known to be modulated by the brain’s opioid system such as social stressors, physical pain and rewards.

    Additional main objectives at week 26 and week 52 after treatment discontinuation
    6. Participants current use of illicit substances 26 weeks and 52 weeks after the end of XR-NTX treatment, based on interview
    7. Participants current social situation including employment, housing and familial status 26 weeks and 52 weeks after end of XR-NTX treatment, based on interview
    E.2.2Secondary objectives of the trial
    Updating of objective to include additional monitoring of adverse events after end of treatment
    4. To explore the frequency and type of adverse events of XR-NTX treatment from baseline to week 52. Adverse events will also be monitored up to 12 months after end of treatment.

    Additional Secondary objectives for WP1, WP2, WP3 and WP4 (24 +28 week study)
    13. To explore the post-treatment efficacy of NTX on the current use of illicit substances and social status including employment, housing and familial situation of the participants at 26 weeks and 52 weeks after study termination.
    14. To collect and analyse data on personality and history of adverse events during childhood that may also be important predictors for adherence to treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
    2. Male or female at 18-65 years
    3. Has a current diagnosis of opioid dependence, based on the criteria of the DSM-V (304.00) as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
    4. Is voluntarily seeking treatment for opioid dependence
    5. Completing a stay in a controlled environment with restricted access to substances of abuse with a minimum duration of 7 (seven) days (waived for OMT controls)
    6. Is enrolled in the Norwegian national opioid maintenance treatment (OMT) program ‘LAR’ before discharge from a controlled environment. For subjects who complete & submit their LAR application while in a controlled environment, the investigator may complete enrolment data collection while awaiting response on LAR admission.
    7. If female and of childbearing potential, must agree to use an highly effective acceptable method of contraception for the duration of the study (waived for OMT controls)
    8. Capable of understanding and complying with the study procedures
    E.4Principal exclusion criteria
    1. Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding
    2. Clinically significant medical condition or observed abnormalities that need medical attention and follow-up (including: severe hepatic (Child-Turcotte-Pugh level C) or renal failure, clinically significant symptoms of progressive Acquired Immunodeficiency Syndrome (AIDS))
    3. Severe psychiatric disorder (including: current or recurrent affective disorders with suicidal behavior, psychotic disorders) that need medical attention and follow-up
    4. Use of any excluded medication at screening or anticipated/required use during the study period (including: requiring treatment with opioid medications other than investigational products)
    5. Known intolerance and/or hypersensitivity to XR-NTX, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluent (waived for OMT controls).
    6. Alcoholism defined by the criteria in DSM V
    7. Serious respiratory debilitation.
    8. Any finding that in the view of the PI would compromise the subject’s ability to fulfill the protocol visit schedule or visit requirements
    9. Employment by Alkermes or Reckitt-Benckiser or Curida AS (permanent, temporary contract worker, or designee responsible for the conduct of the study) or immediate family of an Alkermes or Reckitt-Benckiser or Curida employee.
    10. Abnormal laboratory assessments. If pathological values, coordinating investigator will decide if the subject is eligible for participation in the study
    11. Not participating in any other trial that might affect the current study
    E.5 End points
    E.5.1Primary end point(s)
    Additional Primary Endpoints at week 26 and week 52 after treatment discontinuation
    6. Participants current use of illicit substances 26 weeks and 52 weeks after the end of XR-NTX treatment, based on interview
    7. Participants current social situation including employment, housing and familial status 26 weeks and 52 weeks after end of XR-NTX treatment, based on interview
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 and 52 weeks after treatment discontinuation
    E.5.2Secondary end point(s)
    Additional Secondary Endpoints at week 24 and week 52
    14. Personality traits and experience of childhood adversity

    Other secondary endpoints: recovery relevant outcomes:
    6. Death during the study or after end of treatment
    (Correction in point 6 from end of study to end of treatment)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 and 52 weeks
    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 No
    E.6.5Efficacy No
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The importance of mental, physical and societal factors for sustained abstinence and recovery
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Participants will be followed up for safety assessment 3 months after end of treatment. Participants will be enrolled in the OMT program if leaving the study.
    Participants that consent to be contacted will also be followed up 26 weeks and 52 weeks after end of treatment. Adverse event and selected questions from the EuropASI, TSWLS, and VAS questionnaires will be used for assessment of safety, and the current use of illicit substances and the social situation.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
    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.

    European Medicines Agency © 1995-Sat May 18 14:43:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA