Clinical trial • Phase IV • Psychiatry

Buprenorphine; Naloxone for Opioid use disorder | Chronic non-cancer pain

Phase IV trial of Buprenorphine; Naloxone for Opioid use disorder | Chronic non-cancer pain.

Overview

Trial Therapeutic Area: Psychiatry
Trial Disease: Opioid use disorder | Chronic non-cancer pain
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 27-08-2024
First CTIS Authorization Date: 19-09-2024

Trial design

Randomised, test arm: suboxone (buprenorphine/naloxone) — product: 'suboxone 2 mg/0.5 mg sublingual tablets' (sublingual). maximum daily dose listed: 36 mg. comparator arm: methadone (methadone hydrochloride) — oral use; maximum daily dose listed: 60 mg. specific dosing schedule/frequency not specified in available data.-controlled Phase IV trial across 1 site in Netherlands.

Randomised: Yes
Comparator: Test arm: Suboxone (buprenorphine/naloxone) — product: 'Suboxone 2 mg/0.5 mg sublingual tablets' (sublingual). Maximum daily dose listed: 36 mg. Comparator arm: Methadone (methadone hydrochloride) — oral use; maximum daily dose listed: 60 mg. Specific dosing schedule/frequency not specified in available data.
Target Sample Size: 100
Trial Duration For Participant: 183

Eligibility

Recruits 100 No vulnerable population selected. Participants must 'Be able to give informed consent.' Informed consent is required from each participant; subject information and informed consent forms are provided (documents: L1_SIS and ICF (full study participation) and L1_SIS and ICF (single measure)). No assent process (trial enrols adults only)..

Pregnancy Exclusion: Pregnant, lactating, or planning to become pregnant during the study period.
Vulnerable Population: No vulnerable population selected. Participants must 'Be able to give informed consent.' Informed consent is required from each participant; subject information and informed consent forms are provided (documents: L1_SIS and ICF (full study participation) and L1_SIS and ICF (single measure)). No assent process (trial enrols adults only).

Inclusion criteria

{"criterion_text":"- Age 18 or over."}
{"criterion_text":"- Meet ICD-11 criteria for chronic non-cancer pain."}
{"criterion_text":"- Using a prescribed opioid with a morphine equivalent dose of over 60 mg per day for ≥3 months."}
{"criterion_text":"- Have an opioid use disorder according to the DSM-5."}
{"criterion_text":"- Wish to be treated for opioid use disorder."}
{"criterion_text":"- Willing to comply to study procedures."}
{"criterion_text":"- Be able to give informed consent."}

Exclusion criteria

{"criterion_text":"- Pregnant, lactating, or planning to become pregnant during the study period."}
{"criterion_text":"- Have already used buprenorphine or methadone in the last 4 weeks as a maintenance therapy."}
{"criterion_text":"- Escalated use of another substance that prevents safe participation in the study."}
{"criterion_text":"- Have acute psychiatric comorbidity."}
{"criterion_text":"- Severe respiratory insufficiency or depression, such as severe chronic obstructive pulmonary disease GOLD 3 or 4."}
{"criterion_text":"- Serious medical disease, such as severe liver dysfunction (Child-Pugh B or C), severe renal dysfunction (eGFR (MDRD) ≤29), heart failure, current brain trauma)."}
{"criterion_text":"- A Q-T interval of ≥450 ms on an electrocardiograph (ECG)."}
{"criterion_text":"- Hypersensitivity or allergy for buprenorphine, naloxone, methadone or any other substance in the preparations of these medications."}

Endpoints

Primary endpoints

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean score on the Current Opioid Misuse Measure (COMM) questionnaire compared from baseline to two months after initiation of treatment between treatment groups (COMM questionnaire administered at baseline and at 2 months)."}

Secondary endpoints

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean scores on listed questionnaires and results of listed tests compared between baseline and 2- and 6-month timepoints; other outcomes include drug dose and treatment retention."}

Recruitment

Planned Sample Size: 100
Recruitment Window Months: 68
Consent Approach: Participants must be able to give informed consent ('Be able to give informed consent.'). Informed consent obtained from each participant; subject information and informed consent forms are available (documents: L1_SIS and ICF (full study participation) and L1_SIS and ICF (single measure)). No assent process described (adults only).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 100

Netherlands

Earliest CTIS Part Ii Submission Date: 17-09-2024
Latest Decision Or Authorization Date: 19-09-2024
Processing Time Days: 2
Number Of Sites: 1
Number Of Participants: 100

Sites

Site Name: Radboud universitair medisch centrum / RADBOUDUMC
Department Name: Psychiatry
Principal Investigator Name: Arnt Schellekens
Principal Investigator Email: psychiatrie@radboudumc.nl
Contact Person Name: Arnt Schellekens
Contact Person Email: psychiatrie@radboudumc.nl
Number Of Participants: 100

Sponsor

Primary sponsor

Full Name: Stichting Radboud universitair medisch centrum
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Netherlands

Investigational products

Investigational Product Name: Suboxone 2 mg/0.5 mg sublingual tablets
Active Substance: Buprenorphine; Naloxone
Modality: Small molecule
Routes Of Administration: Sublingual use
Route: Sublingual
Authorisation Status: Marketing authorisation present (EU MA: EU/1/06/359/001; authorisationCountryCode: IS)
Starting Dose: 2 mg/0.5 mg (per tablet)
Maximum Dose: 36 mg per day

Investigational Product Name: METHADONE
Active Substance: Methadone hydrochloride
Modality: Small molecule
Routes Of Administration: Oral use
Route: Oral
Authorisation Status: No marketing authorisation number listed (marketingAuthNumber: -) in product data
Maximum Dose: 60 mg per day

Combination Treatment: Yes

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