Recruiting
Phase 3

Methadone & Morphine

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT02687347

Conditions

Pain, Intractable

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

oral methadone

oral morphine

Study Details

Brief summary:

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.

Conditions

Pain, Intractable

Study ID

NCT02687347

Start date

Feb, 2016

Status verified date

Sep, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Feb, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: study arm

low dose methadone (1-10mg daily)

active comparator: control arm

low dose morphine (1-10 mg/day)

Interventions

oral methadone

Oral methadone is the study drug

oral morphine

Oral morphine is the active comparator. It is not a placebo intervention

Primary outcome measure

  • pain relief [ Time Frame: 2 months ]
  • pain relief [ Time Frame: 2 months ]

Central Contacts and Locations

Locations

Alan Edwards Pain Management Unit. Mcgill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G1A4

Contacts

Jordi Perez, MD

5149348222jordi.perez@muhc.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Sep 20, 2016

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2016-09-20.