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Sublingual Methadone for the Management of Cancer Breakthrough Pain

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ClinicalTrials.gov Identifier: NCT00125294
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Calgary Health Region
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Methadone Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Determine optimal dose titration
  2. Determine assessment protocol


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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00125294


Sponsors and Collaborators
AHS Cancer Control Alberta
Calgary Health Region
Investigators
Principal Investigator: Neil Hagen Alberta Cancerboard

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00125294     History of Changes
Other Study ID Numbers: 17208
Calgary Health Region
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: August 2011

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

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