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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351637
Recruitment Status : Terminated (Study suspended due to low accrual)
First Posted : July 13, 2006
Last Update Posted : January 19, 2012
Information provided by:
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 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 or disease Intervention/treatment Phase
Cancer Pain Drug: Sublingual Methadone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00351637     History of Changes
Other Study ID Numbers: 20145
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

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
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents