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

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: NCT00351715
Recruitment Status : Terminated (Study stopped due to low accrual)
First Posted : July 13, 2006
Last Update Posted : January 28, 2013
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 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.

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 Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting

Secondary Outcome Measures :
  1. to develop a model of PK/PD study of breakthrough pain
  2. to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
  3. to demonstrate proof of concept

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00351715

Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Sponsors and Collaborators
Alberta Health Services
Principal Investigator: Neil Hagen, MD AHS Cancer Control Alberta Identifier: NCT00351715     History of Changes
Other Study ID Numbers: 20144
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: October 2008

Keywords provided by AHS Cancer Control Alberta:
Sublingual Methadone
Cancer related breakthrough pain
feasibility study
Phase II/open label
Safety/ efficacy
previously receiving opioids
speak English

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents