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Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial (SUMO study).

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513924-41-01
Enrollment
100
Registered
2024-09-19
Start date
2022-05-11
Completion date
Unknown
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid use disorder (DSM-5); chronic non-cancer pain (ICD-11).

Brief summary

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.

Detailed description

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.

Interventions

Sponsors

Stichting Radboud universitair medisch centrum
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026