Sublingual Methadone for the Management of Cancer Breakthrough Pain

Condition(s) targeted: Cancer; Pain

Intervention: Methadone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alberta Health Services

Official(s) and/or principal investigator(s):
Neil Hagen, Principal Investigator, Affiliation: Alberta Cancerboard

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

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Determine optimal dose titration

Determine assessment protocol

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: September 2003
Last updated: January 18, 2012