Sublingual Methadone for the Management of Cancer Breakthrough Pain

This study has been completed.

First Received: July 29, 2005 Last Updated: March 31, 2009 History of Changes

Sponsor:	Alberta Health Services
Collaborator:	Calgary Health Region
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00125294

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-availability Study
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

Drug Information available for: Methadone Methadone hydrochloride

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

Study ID Numbers:	17208, Calgary Health Region
Study First Received:	July 29, 2005
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00125294 History of Changes
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:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010