Sublingual Methadone for the Management of Cancer Breakthrough Pain

Overview

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

Full Title of Study: “Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2006

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.

Interventions

  • Drug: Methadone

Clinical Trial Outcome Measures

Primary Measures

  • Determine optimal dose titration
  • Determine assessment protocol

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AHS Cancer Control Alberta
  • Collaborator
    • Calgary Health Region
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Neil Hagen, Principal Investigator, Alberta Cancerboard

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