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    Summary
    EudraCT Number:2013-004024-11
    Sponsor's Protocol Code Number:60-60600-97-103
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-004024-11
    A.3Full title of the trial
    New pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands: A double-blind, placebo-controlled randomized feasibility study of sustained release dexamphetamine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New pharmacologic treatment for crack-cocaine addicts in the Netherlands: A randomized feasibility study comparing sustained release dexamphetamine with placebo
    A.4.1Sponsor's protocol code number60-60600-97-103
    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 SponsorAcademic Psychiatric Center - AMC-UvA
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBrijder Addiction Treatment
    B.5.2Functional name of contact pointDr. Vincent M. Hendriks
    B.5.3 Address:
    B.5.3.1Street AddressMonsterseweg 83
    B.5.3.2Town/ cityThe Hague
    B.5.3.3Post code2553 RJ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310883852034
    B.5.5Fax number310703917773
    B.5.6E-mailVincent.Hendriks@Brijder.nl
    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 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 nameDexamphetamine sulphate 30 mg controlled release tablets
    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 INNDexamfetamine sulphate controlled release
    D.3.9.3Other descriptive nameDEXTROAMPHETAMINE SULFATE
    D.3.9.4EV Substance CodeSUB120460
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    cocaine dependence (according DSM-IV)
    E.1.1.1Medical condition in easily understood language
    addiction to cocaine, in its inhalable form (i.e., crack-cocaine or base-coke)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009817
    E.1.2Term Cocaine dependence
    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
    This double-blind, placebo-controlled RCT aims to evaluate, in crack-cocaine dependent patients with comorbid heroin dependence, the response to medically prescribed oral dexamphetamine SR (60 mg/day) as an add-on to heroin-assisted treatment, in terms of cocaine use.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this trial are to evaluate, the response to medically prescribed oral dexamphetamine SR (60 mg/day) as an add-on to heroin-assisted treatment, in terms of substance use (other than cocaine), (physical, mental and social) health, as well as acceptance, medication compliance, safety, and patient satisfaction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To qualify for heroin-assisted treatment, patients must meet a set of well-defined selection criteria pertaining to the situation prior to the start of heroin-assisted treatment, which include that the patient must be at least 25 years old, and have a treatment-resistant heroin dependency, as indicated by (a) a history of heroin dependence (DSM-IV) of at least five years, (b) a minimum dose of 50 mg/day (patients who inhale their heroin) or 60 mg/day (patients who inject their heroin) of methadone for an uninterrupted period of at least 4 weeks in the previous 5 years, (c) a history of regular treatment contacts with the methadone program in the previous 6 months, (d) a history of unsuccessful methadone maintenance treatments, (e) daily or nearly daily use of illicit heroin, and (f) poor physical, mental or social functioning (Van den Brink et al., 2003). It is important to note that these selection criteria for participation in heroin-assisted treatment pertain to the situation prior to the start of heroin-assisted treatment, which for most patients is (far) more than a year ago.

    To be eligible for the present study, patients must:
    1. be at least 25 years old;
    2. be cocaine dependent (DSM-IV) during at least the previous 5 years;
    3. use cocaine on a regular basis (i.e., ≥ 8 days) in the previous month;
    4. administer their cocaine primarily by means of basing ('crack');
    5. have a history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment-refractory'). In order to qualify as 'treatment-refractory', the patient must have had at least two earlier treatment episodes targeted at reduction of cocaine use, yet still be cocaine dependent in the previous year, and use cocaine on a regular basis in the previous month;
    6. be able and willing to participate in the study treatment and assessments;
    7. have provided written informed consent.
    E.4Principal exclusion criteria
    Patients will be excluded in case of:
    1. severe medical (e.g., severe renal or kidney insufficiency/failure, hypertension, glaucoma) or psychiatric problems (e.g., acute psychosis or history of drug-induced psychotic disorder, acute suicidality), which constitute a contraindication for participation;
    2. cardiovascular problems (ECG);
    3. (desired) pregnancy or continued lactation;
    4. anticipated necessity of inpatient treatment (clinical judgement);
    5. insufficient command of the Dutch language;
    6. current participation in another addiction treatment trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure pertains to cocaine use, and is defined as the total number of days of crack-cocaine use during the 12 weeks study period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome measure will be assessed after 4, 8, and 12 weeks treatment (by means of the Time-Line Follow-Back method)
    E.5.2Secondary end point(s)
    Secondary, cocaine use related outcome measures are:
    1) longest duration of cocaine abstinence;
    2) the number of days cocaine abstinence in the four weeks preceding the week 12 assessment
    3) the mean proportion of cocaine metabolite-free urine samples in the four weeks preceding the week 12 assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary, cocaine use related outcome measures will be assessed after 4, 8, and 12 weeks treatment (by means of the Time-Line Follow-Back method and urinalysis)
    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 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 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 concerned4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 72
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    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)
    Following the end of the 12 weeks trial period, patients will continue heroin-assisted treatment, but the study medication (either placebo or sustained release dexamphetamine; due to blinding unknown to both the treatment physician and research staff) will be terminated in all patients, and all usual treatment options in Dutch addiction care will be available to the patients, if indicated.
    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 Decision2014-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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