Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain (UDOME)

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McGill University

Status and phase

Unknown
Phase 3

Conditions

Pain, Intractable

Treatments

Drug: oral morphine
Drug: oral methadone

Study type

Interventional

Funder types

Other

Identifiers

NCT02687347
15-369 MP-CUSM

Details and patient eligibility

About

The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.

Enrollment

204 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed of cancer-related pain of more than 3 months duration
  • Pain relief during the last week rated unsatisfactory by the patient
  • Pain severity during the last week rated moderate (between 4 and 7/10)
  • Analgesic therapy must have been stable for 7 days
  • Able to understand English or French
  • Willing and able to give written informed consent

Exclusion criteria

  • Patients who are currently receiving or have received methadone as analgesic in the last 6 months
  • Contraindication to receive methadone (allergy, QTc segment on the ECG>450msec, concurrent treatment with medication that could increase methadone's effects)
  • Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
  • Patients whose life expectancy is shorter than 2 months
  • Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
  • Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

204 participants in 2 patient groups

study arm
Experimental group
Description:
low dose methadone (1-10mg daily)
Treatment:
Drug: oral methadone
control arm
Active Comparator group
Description:
low dose morphine (1-10 mg/day)
Treatment:
Drug: oral morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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