Sublingual Methadone for the Management of Cancer Breakthrough Pain

Phase 1

Completed

• Conditions: Cancer; Pain

• Registration Number: NCT00125294
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study First Posted: 2005-08-01
• Primary Completion: 2006-06
• Study Completion: 2007-01
• Status Verified: 2011-08
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine assessment protocol
Determine optimal dose titration