A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country204 target enrollmentFebruary 2016

ConditionsPain, Intractable

Interventionsoral methadone oral morphine

Drugsoral methadone oral morphine

Overview

Phase: Phase 3
Intervention: oral methadone
Conditions: Pain, Intractable
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment: 204
Locations: 1
Primary Endpoint: pain relief
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

December 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Principal Investigator

Jordi Perez

Codirector Cancer Pain Program. McGill University Health Centre. Montreal, Canada

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

Eligibility Criteria

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)