ClinicalTrials.gg
CompletedNCT00125294Updated Sep 25, 2017

Sublingual Methadone for the Management of Cancer Breakthrough Pain

A Phase 1 interventional study of Methadone in Cancer and Pain, sponsored by AHS Cancer Control Alberta. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by AHS Cancer Control Alberta · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cancer
  • Pain

Keywords

  • cancer pain
  • breakthrough pain
  • methadone
  • dose titration
  • sublingual route of administration
  • Cancer related pain
  • currently taking narcotics
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.

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Lead sponsor

AHS Cancer Control Alberta is the lead sponsor of 187 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

Exclusion criteria

Exclusion Criteria:

  • Currently or has received methadone during the previous week
  • Recent history of substance abuse
  • Severe respiratory impairment or other to opioids
  • Recently received therapies that had the potential to alter pain intensity or response to analgesics
  • Symptomatic anemia
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Determine optimal dose titration

  2. Determine assessment protocol

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00125294
Collaborators
Calgary Health Region
Responsible party
Sponsor
First posted
Aug 1, 2005
Start date
Sep 2003
Primary completion
Jun 2006
Completion
Jan 2007
Last update
Sep 25, 2017

Study contacts

Neil Hagen
principal investigator · Alberta Cancerboard
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Methadone

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