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

Phase 3

• Conditions: Pain, Intractable
• Interventions: Drug: oral methadone; Drug: oral morphine

• Registration Number: NCT02687347
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-20
• Primary Completion: 2018-02
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study arm	oral methadone	low dose methadone (1-10mg daily)
control arm	oral morphine	low dose morphine (1-10 mg/day)

Primary Outcome Measures

Name	Time	Method
pain relief	2 months	Questions 3 to 6 of the Brief Pain Inventory

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".	2 months	prevalence and severity of opioid induced side effects

Trial Locations

Locations (1)

Alan Edwards Pain Management Unit. Mcgill University Health Centre; 🇨🇦 Montreal, Quebec, Canada