Sublingual Methadone for the Management of Cancer Breakthrough Pain

September 21, 2017 updated by: AHS Cancer Control Alberta

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine optimal dose titration
Determine assessment protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

Calgary Health Region

Investigators

  • Principal Investigator: Neil Hagen, Alberta Cancerboard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 29, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17208
  • Calgary Health Region

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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