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    Summary
    EudraCT Number:2021-001817-35
    Sponsor's Protocol Code Number:111958
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2021-001817-35
    A.3Full title of the trial
    Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial.
    Suboxone (buprenorfine/naloxon) versus methadon opioïdrotatie in patiënten met geëscaleerd opioïdgebruik en chronische pijn: een gerandomiseerde studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of opioid dependency in patients with chronic pain: a comparative study between suboxone and methadone.
    Behandeling van opiaatafhankelijkheid bij pijn: een vergelijkende studie met suboxone en methadon.
    A.3.2Name or abbreviated title of the trial where available
    SUMO
    SUMO
    A.4.1Sponsor's protocol code number111958
    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 SponsorRadboud University Medical Center
    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 supportDutch Research Council (NWO)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointDepartment of psychiatry
    B.5.3 Address:
    B.5.3.1Street AddressReinier Postlaan 4
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GC
    B.5.3.4CountryNetherlands
    B.5.6E-mailpsychiatrie@radboudumc.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 Yes
    D.2.1.1.1Trade name Suboxone
    D.2.1.1.2Name of the Marketing Authorisation holderIndivior Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUPRENORPHINE
    D.3.9.1CAS number 52485-79-7
    D.3.9.4EV Substance CodeSUB05985MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALOXONE
    D.3.9.1CAS number 465-65-6
    D.3.9.4EV Substance CodeSUB09142MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 4
    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 RoleComparator
    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 Methadone
    D.2.1.1.2Name of the Marketing Authorisation holdermultiple marketing authorisation holders
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMethadone
    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 INNMETHADONE
    D.3.9.1CAS number 76-99-3
    D.3.9.4EV Substance CodeSUB08833MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 50
    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 use disorder
    Stoornis in het opioïdgebruik
    E.1.1.1Medical condition in easily understood language
    Dependence on opioids
    Afhankelijkheid aan opiaten
    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
    To compare the effectivity of suboxone and methadone on reducing self-reported opioid misuse.
    Het vergelijken van de effectiviteit van suboxone en methadon op het terubrengen van zelf-gerapporteerd opiaatmisbruik.
    E.2.2Secondary objectives of the trial
    - To compare the effectivity of suboxone and methadone on reducing pain.
    - To compare the effects of suboxone and methadone on well-being.
    - To compare the effects of suboxone and methadone on drug use.
    - Het vergelijken van de effectiviteit van suboxone en methadon op het terugbrengen van pijn.
    - Het vergelijken van de effecten van suboxone en methadon op welbevinden.
    - Het vergelijken van effecten van suboxone en methadon op het medicatie gebruik.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 or over.
    - Meet ICD-11 criteria for chronic non-cancer pain.
    - Using a prescribed opioid with a morphine equivalent dose of over 60 mg per day for ≥3 months.
    - Have an opioid use disorder according to the DSM-5.
    - Wish to be treated for opioid use disorder.
    - Willing to comply to study procedures.
    - Be able to give informed consent.
    - 18 jaar of ouder.
    - Voldoet aan de ICD-11 criteria voor chronische niet-kanker pijn.
    - Gebruik van voorgeschreven opioïde medicatie met een morfine equivalente dosis van ≥60 mg/d voor ≥3 maanden.
    - Voldoet aan DSM-5 criteria voor stoornis in het middelengebruik (opioïden).
    - Wens om behandeld te worden voor stoornis in het opioïdgebruik.
    - Bereid om mee te doen aan studie procedures.
    - In staat zijn om informed consent te geven.
    E.4Principal exclusion criteria
    - Pregnant, lactating, or planning to become pregnant during the study period.
    - Have already used buprenorphine or methadone in the last 4 weeks as a maintenance therapy.
    - Escalated use of another substance that prevents safe participation in the study.
    - Have acute psychiatric comorbidity.
    - Severe respiratory insufficiency or depression, such as severe chronic obstructive pulmonary disease GOLD 3 or 4.
    - Serious medical disease, such as severe liver dysfunction (Child-Pugh B or C), severe renal dysfunction (eGFR (MDRD) ≤29), heart failure, current brain trauma).
    - A Q-T interval of ≥450 ms on an electrocardiograph (ECG).
    - Hypersensitivity or allergy for buprenorphine, naloxone, methadone or any other substance in the preparations of these medications.
    - Zwanger, van plan zwanger te worden tijdens de studieperiode of geeft borstvoeding.
    - Heeft in de afgelopen 4 weken al buprenorfine of methadon als onderhoudsbehandeling gebruikt.
    - Geëscaleerd gebruik van een ander middel dat veilige deelname aan het onderzoek verhinderd.
    - Acute psychiatrische problematiek.
    - Ernstige ademhalingsinsufficiëntie, zoals COPD GOLD 3 of 4.
    - Ernstige medische aandoening, zoals leverfalen (child-pugh B of C), nierfalen (eGFR (MDRD) ≤29), hartfalen, of acuut hersentrauma.
    - Q-T interval van ≥450 ms op een ECG.
    - Allergie voor een bestandsdeel in de preparatie van suboxone of methadon.
    E.5 End points
    E.5.1Primary end point(s)
    The mean score on the Current Opioid Misuse Measure (COMM) questionnaire compared from baseline to two months after initiation of treatment between the suboxone and methadone treatment groups.
    De gemiddelde score op de Current Opioid Misuse Measure (COMM) vragenlijst, vergeleken van de nulmeting naar 2 maanden na start van behandeling, tussen de suboxone en methadon groepen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months after initiation of treatment.
    2 maanden na start van behandeling.
    E.5.2Secondary end point(s)
    The mean scores on the following measures, compared between both treatments from baseline to two and six months after initiation of treatment.
    Questionnaires: COMM, VAS-pain, BPI, CSI, VAS-QOL, WHOQOLBREF, DASS, VAS-craving, OCDS, GPE, ORSDS, FFMQ-SF, SCS, TCQ, CFQ.
    Tests: quantitative sensory testing, 6-minutes walking test, urine toxicology, MoCA, 15WT, SCWT, PASAT.
    Other: dose of drug, treatment retention.

    We will also ask patients to fill the SOAPP-R, SR-MAD and ORT questionnaires, to validate these questionnaires. A genetic sample will be taken to study whether genetic data can predict treatment outcomes.
    De gemiddelde scores voor metingen op de volgende domeinen, vergeleken tussen beide behandelcondities van de nulmeting naar 2 en 6 maanden na start van de behandeling;
    Vragenlijsten: COMM, VAS-pijn, BPI, CSI, VAS-QOL, WHOQOL-BREF, DASS, VAS-zucht, OCDS, GPE, ORSDS, FFMQ-SF, SCS, TCQ, CFQ.
    Testen: kwantitatieve sensorische testen, 6-minuten wandel test, urine toxicologie, MoCA, 15WT, SCWT, PASAT.
    Overig: dosering van medicatie, behandelretentie.

    Ook wordt de SOAPP-R, SR-MAD en ORT vragenlijsten afgenomen om deze vragenlijsten te valideren. Daarnaast wordt er genetisch materiaal afgenomen om te onderzoeken of genetica behandeluitkomsten kan voorspellen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 and 6 months after initiation of treatment.
    2 en 6 maanden na start van de behandeling.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 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
    The last visit of the last subject undergoing the trial.
    Het laatste bezoek van de laatste deelnemer aan de trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state100
    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)
    Follow-up after participation will be according to regular care procedures.
    Follow-up gaat volgens de procedures van reguliere zorg.
    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 Decision2021-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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