Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Opioid use disorder (DSM-5); chronic non-cancer pain (ICD-11).
To compare the effectivity of suboxone (buprenorphine/naloxone) and methadone on reducing self-reported opioid misuse.
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 11 May 2022 → ongoing
- Decision date (initial)
- 2024-09-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513924-41-01
- EudraCT number
- 2021-001817-35
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare the effectivity of suboxone (buprenorphine/naloxone) and methadone on reducing self-reported opioid misuse.
Secondary objectives 4
- 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 cognition.
- To compare the effects of suboxone and methadone on drug use.
Conditions and MedDRA coding
Opioid use disorder (DSM-5); chronic non-cancer pain (ICD-11).
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- NA
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513924-41-00 | Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial (SUMO study) | Stichting Radboud universitair medisch centrum |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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.
Exclusion criteria 8
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Suboxone 2 mg/0.5 mg sublingual tablets
PRD3489590 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 36 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC51 — -
- Marketing authorisation
- EU/1/06/359/001
- MA holder
- INDIVIOR EUROPE LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SCP101887829 · ATC
- Active substance
- Methadone Hydrochloride
- Substance synonyms
- DL-6-DIMETHYLAMINO-4,4-DIPHENYL-3-HEPTANONE HYDROCHLORIDE, (±)-METHADONE HYDROCHLORIDE, PHENADONE HYDROCHLORIDE
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC02 — METHADONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- SUMO research team
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- SUMO research team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum / RADBOUDUMC
Psychiatry, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2022-05-11 | 2022-05-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513924-41-01 | 3.2 |
| Recruitment arrangements (for publication) | blanco document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF (full study participation) | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF (single measure) | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC methadone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC suboxone | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-27 | Netherlands | Acceptable with conditions 2024-09-19
|
2024-09-19 |