Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients

This study has been terminated.
(Study suspended due to low accrual)
Information provided by:
AHS Cancer Control Alberta Identifier:
First received: July 11, 2006
Last updated: January 18, 2012
Last verified: January 2012
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the impatient population, in the clinical setting of preventing or managing breakthrough pain, 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 effective dose of sublingual methadone.

Condition Intervention Phase
Drug: Sublingual Methadone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study

Resource links provided by NLM:

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic,
  • treatment related incident breakthrough pain.

Secondary Outcome Measures:
  • to develop a research tool
  • the Breakthrough Pain Assessment Tool (BPAT)
  • and to demonstrated proof of concept

Estimated Enrollment: 60
Study Start Date: December 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pain due to cancer or its treatment; Controlled baseline pain; episodes of predictable, treatment related pain every day that are 4"/10" in severity or greater, last 10 minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a 2-minute period; are able to provide written informed consent; are able to fill out the study forms, and are inpatients

Exclusion Criteria:

  • Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses od opioid; prior sensitivity to methadone; currently are being administered methadone; are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely; and if they do not understand English sufficiently to provide written informed consent.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00351637

Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Principal Investigator: Neil Hagen, MD AHS Cancer Control Alberta
  More Information

No publications provided Identifier: NCT00351637     History of Changes
Other Study ID Numbers: 20145, 22206
Study First Received: July 11, 2006
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Sublingual methadone
treatment related incident breakthrough pain
feasibility study
Phase II/open-label
Cancer related breakthrough pain
previously receiving opioids
speak English

Additional relevant MeSH terms:
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses processed this record on November 27, 2015