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Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Pain

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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

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