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    Summary
    EudraCT Number:2010-021384-33
    Sponsor's Protocol Code Number:NTXMR1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-06-29
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-021384-33
    A.3Full title of the trial
    The Effect of Naltrexone on Amphetamine Cue Reactivity: An fMRI Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect of Naltrexone in Amphetamine Dependence: A Study using Functional Magnetic Resonance Imaging
    A.4.1Sponsor's protocol code numberNTXMR1
    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 SponsorBeroendecentrum Stockholm
    B.1.3.4CountrySweden
    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 supportSwedish Brain Fund
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportMärta Lundqvists stiftelse
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact pointCentrum för psykiatriforskning
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital R5:01
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number+46736003551
    B.5.5Fax number+468123 496 02
    B.5.6E-mailjoar.guterstam@ki.se
    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 Naltrexon
    D.2.1.1.2Name of the Marketing Authorisation holderAOP Orphan Pharmaceuticals AG
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form 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
    D.3.9.1CAS number 16590413
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amphetamine dependence
    E.1.1.1Medical condition in easily understood language
    Amphetamine dependence
    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
    Evaluating the effects of naltrexone on reward function and processing of amphetamine-related cues in amphetamine dependent patients, using functional magnetic resonance imaging.
    E.2.2Secondary objectives of the trial
    Comparison of reward processing between amphetamine dependent patients and healthy controls.
    Evaluation of the effect of naltrexone on pain processing in healthy controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men between the ages 20-55 years
    Fulfils DSM-IV diagnosis for amphetamine dependence
    Minimum of 2 years history of amphetamine dependence
    History of intravenous amphetamine use
    Consumed amphetamine for minimum of 12 times in the last 12 weeks
    Drug free 1-30 days (minimum 24 hours)
    Abstinent from nicotine and caffeine during the testing day

    A healthy control group is also selected according to the following inclusion criteria:
    Men between 20-55 years, judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs.
    E.4Principal exclusion criteria
    Fulfils DSM-IV diagnosis of any other substance dependence disorder (except nicotine)
    Fulfils DSM-IV diagnosis of any major psychiatric illness (e.g. bipolar affective disorder, schizophrenia)
    Left-handedness
    No clinical signs of amphetamine intoxication at the day of testing
    Traces of cannabis, opiates, cocaine or benzodiazepines in the urine at the day of testing
    Traces of alcohol as measured by breathalyser at the day of testing
    Implant of pacemaker or any metallic object that might interfere with the magnetic field
    Presence of severe somatic disorder (e.g. renal or hepatic failure)
    Regular use of medication that may interact with study medication (e.g., opioid pain killers)
    Experience with naltrexone during last six months
    Known hypersensitivity to naltrexone

    The healthy control group will be selected according to the following exclusion criteria:
    Fulfils DSM IV diagnosis of any substance dependence disorder in self or in first degree relatives (parents, children or siblings)
    Smoker (including snuff or any other nicotine product) and fulfils DSM IV diagnosis of nicotine dependence
    Fulfils DSM IV diagnosis of any major psychiatric illness in self or in first degree relatives (parents, children or siblings)
    Left-handedness
    Traces of cannabis, opiates, cocaine, central amines or benzodiazepines in the urine at test day
    Traces of alcohol as measured by breathalyzer at test day
    Implant of pacemaker or any metallic object that might interfere with the magnetic field
    Use of any concomitant medication
    Known hypersensitivity to naltrexone.
    E.5 End points
    E.5.1Primary end point(s)
    fMRI BOLD signal in the brain reward system during exposure to amphetamine-related cues of different kinds. Functional connectivity as measured by fMRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During cue presentation in the MR camera, at least 60 minutes after intake of study medication.
    E.5.2Secondary end point(s)
    Behavioral data on subjective craving and experience of pain.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immediately after cue presentations and painful stimuli, respectively.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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. However, if data collection for the last healthy participant is finished before the last patient, the randomization code for the healthy participants may be broken in order to allow analysis of experiments specific for that group. This will not in any way affect the recruitment and study procedures for the patients, which will continue in a double-blind manner.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 70
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state70
    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)
    None.
    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 Decision2010-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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