Sublingual Methadone for the Management of Cancer Breakthrough Pain

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Methadone

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer pain, breakthrough pain, methadone, dose titration, sublingual route of administration, Cancer related pain, currently taking narcotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Determine optimal dose titration

Determine assessment protocol

Secondary Outcome Measures

Full Information

NCT ID

NCT00125294

First Posted

July 29, 2005

Last Updated

September 21, 2017

Sponsor

AHS Cancer Control Alberta

Collaborators

Calgary Health Region

1. Study Identification

Unique Protocol Identification Number

NCT00125294

Brief Title

Sublingual Methadone for the Management of Cancer Breakthrough Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Calgary Health Region

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Pain

Keywords

cancer pain, breakthrough pain, methadone, dose titration, sublingual route of administration, Cancer related pain, currently taking narcotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Methadone

Primary Outcome Measure Information:

Title

Determine optimal dose titration

Title

Determine assessment protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Hagen

Organizational Affiliation

Alberta Cancerboard

Official's Role

Principal Investigator

Cancer, Pain

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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