CancerPhase 1NCT00125294
Sublingual Methadone for the Management of Cancer Breakthrough Pain
A Phase 1 study testing Methadone in people with Cancer and Pain, run by AHS Cancer Control Alberta.
Trial summary
A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Methadone
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
About this study
Official title: 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.
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.
- Being tested
- Methadone
- Keywords
- cancer pain, breakthrough pain, methadone, dose titration, sublingual route of administration, Cancer related pain, currently taking narcotics
- Medical subject headings
- Neoplasms, Pain, Cancer Pain, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine optimal dose titration
Determine assessment protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Calgary Health Region
- Responsible party
- Sponsor
- Investigators
- Neil Hagen, Principal investigator, Alberta Cancerboard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125294
- Sponsor's protocol ID
- 17208
- Other IDs
- Calgary Health Region
- Status last verified
- Aug 2011
- First submitted
- 29 Jul 2005
- Last updated
- 25 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain
- ClinicalTrials.gov ID
- NCT00125294
- Acronym / sponsor ID
- 17208
- Keywords
- cancer pain, breakthrough pain, methadone, dose titration, sublingual route of administration, Cancer related pain, currently taking narcotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Calgary Health Region
- Study start
- Sep 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone | Drug | – |
Primary outcome
Determine optimal dose titration
Determine assessment protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Hagen principal investigator
Alberta Cancerboard
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methadone in people with Cancer and Pain, run by AHS Cancer Control Alberta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine optimal dose titration. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.