Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT00125294
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2005-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Methadone for the Management of Cancer Breakthrough Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D059390', 'term': 'Breakthrough Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-21', 'studyFirstSubmitDate': '2005-07-29', 'studyFirstSubmitQcDate': '2005-07-29', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine optimal dose titration'}, {'measure': 'Determine assessment protocol'}]}, 'conditionsModule': {'keywords': ['cancer pain', 'breakthrough pain', 'methadone', 'dose titration', 'sublingual route of administration', 'Cancer related pain', 'currently taking narcotics'], 'conditions': ['Cancer', 'Pain']}, 'descriptionModule': {'briefSummary': 'A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.', 'detailedDescription': 'This is a dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n* Experiences episodes of breakthrough pain which respond to opioid therapy\n* Controlled baseline pain\n* Cognitive status sufficient for accurate completion of assessment form\n* Willing to provide written informed consent\n* Ability to hold a volume of 1 cc of water under the tongue for 5 minutes\n\nExclusion Criteria:\n\n* Currently or has received methadone during the previous week\n* Recent history of substance abuse\n* Severe respiratory impairment or other contraindications to opioids\n* Recently received therapies that had the potential to alter pain intensity or response to analgesics\n* Symptomatic anemia'}, 'identificationModule': {'nctId': 'NCT00125294', 'briefTitle': 'Sublingual Methadone for the Management of Cancer Breakthrough Pain', 'organization': {'class': 'OTHER', 'fullName': 'AHS Cancer Control Alberta'}, 'officialTitle': 'Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain', 'orgStudyIdInfo': {'id': '17208'}, 'secondaryIdInfos': [{'id': 'Calgary Health Region'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Methadone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Neil Hagen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alberta Cancerboard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHS Cancer Control Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Calgary Health Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}