Trial Information
Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain
This is a dose titration protocol for sublingual methadone hydrochloride for the management
of cancer-related breakthrough pain to find the optimal dose.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine optimal dose titration
Principal Investigator
Neil Hagen
Investigator Role:
Principal Investigator
Investigator Affiliation:
Alberta Cancerboard
Authority:
Canada: Health Canada
Study ID:
17208
NCT ID:
NCT00125294
Start Date:
September 2003
Completion Date:
January 2007
Related Keywords:
- Cancer
- Pain
- cancer pain
- breakthrough pain
- methadone
- dose titration
- sublingual route of administration
- Cancer related pain
- currently taking narcotics
