Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients

Phase 2

Terminated

• Conditions: Pain; Cancer
• Interventions: Drug: Sublingual Methadone

• Registration Number: NCT00351715
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-11
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-13
• Study Start: 2008-07
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Pain due to cancer or its treatment; controlled baseline pain;
• episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
• ast 10 minutes or longer, and
• are responsive to short acting oral opioids such as morphine or hydromorphone;
• are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
• are able to fill out the study forms

Exclusion Criteria

• Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
• prior sensitivity to methadone;
• currently are being administered methadone;
• have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
• new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
• are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic	Sublingual Methadone	One episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of \>90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards

Primary Outcome Measures

Name	Time	Method
to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting	12 months

Secondary Outcome Measures

Name	Time	Method
to demonstrate proof of concept	Baseline to 5 years
to develop a model of PK/PD study of breakthrough pain	Baseline to 5 years
to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)	Baseline to 5 years

Trial Locations

Locations (2)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Tom Baker Cancer Center; 🇨🇦 Calgary, Alberta, Canada