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Sublingual Methadone for the Management of Cancer Breakthrough Pain

This study has been completed.
Sponsor:
Collaborator:
Calgary Health Region
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00125294
First received: July 29, 2005
Last updated: January 18, 2012
Last verified: August 2011
History of Changes
  Purpose

A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.


Condition Intervention Phase
Cancer
Pain
 Drug: Methadone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Determine optimal dose titration
  • Determine assessment protocol

Estimated Enrollment: 10
Study Start Date: September 2003
Study Completion Date: January 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This is a dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

  Eligibility

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

Inclusion Criteria:

  • > 18 years of age
  • Experiences episodes of breakthrough pain which respond to opioid therapy
  • Controlled baseline pain
  • Cognitive status sufficient for accurate completion of assessment form
  • Willing to provide written informed consent
  • Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

Exclusion Criteria:

  • Currently or has received methadone during the previous week
  • Recent history of substance abuse
  • Severe respiratory impairment or other contraindications to opioids
  • Recently received therapies that had the potential to alter pain intensity or response to analgesics
  • Symptomatic anemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125294

Sponsors and Collaborators
Alberta Health Services
Calgary Health Region
Investigators
Principal Investigator: Neil Hagen Alberta Cancerboard
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125294     History of Changes
Other Study ID Numbers: 17208, Calgary Health Region
Study First Received: July 29, 2005
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
cancer pain
breakthrough pain
methadone
dose titration
 sublingual route of administration
Cancer related pain
currently taking narcotics

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013