E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Opioid use disorder |
Stoornis in het opioïdgebruik |
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E.1.1.1 | Medical condition in easily understood language |
Dependence on opioids |
Afhankelijkheid aan opiaten |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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.
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- 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 months after initiation of treatment. |
2 maanden na start van behandeling. |
|
E.5.2 | Secondary 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 and 6 months after initiation of treatment. |
2 en 6 maanden na start van de behandeling. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |