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Sublingual Methadone for the Management of Cancer Breakthrough Pain

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00125294
Enrollment
10
Registered
2005-08-01
Start date
2003-09-30
Completion date
2007-01-31
Last updated
2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pain

Keywords

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

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.

Interventions

DRUGMethadone

Sponsors

Calgary Health Region
CollaboratorOTHER
AHS Cancer Control Alberta
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Determine optimal dose titration
Determine assessment protocol

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026