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

Radboud University Medical Center0 sites100 target enrollmentStarted: June 8, 2021Last updated: April 4, 2022

Conditions

Drugs

Trial Snapshot

No summary available.

•- Age 18 or over.
•- Meet ICD-11 criteria for chronic non-cancer pain.
•- Using a prescribed opioid with a morphine equivalent dose of over 90 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- 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.

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