Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 8:57 AM
Study NCT ID:
NCT00699634
Status:
COMPLETED
Last Update Posted:
2011-04-29
First Post:
2008-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nabilone for the Treatment of Phantom Limb Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011941', 'term': 'nabilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2008-06-17', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale for Pain', 'timeFrame': 'Baseline, 2, 4 and 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Depression Anxiety and Stress Scale', 'timeFrame': 'Baseline, 2, 4 and 6 weeks'}, {'measure': 'Groningen Sleep Quality Scale', 'timeFrame': 'Baseline, 2, 4 and 6 weeks'}, {'measure': 'SF-36', 'timeFrame': 'Baseline, 2, 4 and 6 weeks'}, {'measure': 'Frequency of phantom limb pain', 'timeFrame': 'Baseline, 2, 4 and 6 weeks'}, {'measure': 'Daily prosthetic wearing time', 'timeFrame': 'Baseline, 2, 4 and 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuropathic', 'Pain', 'Phantom', 'Limb'], 'conditions': ['Phantom Limb Pain', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this proposed study is to conduct a randomized double-blind placebo controlled trial assessing the benefit of nabilone in pain management and improvement of quality of life in patients with phantom limb pain.\n\nOur Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the phantom limb pain and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the Groningen Sleep Quality Scale and daily prosthetic wearing time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient has been diagnosed with phantom limb pain by a Rehabilitation Medicine Specialist.\n* 18-70 years old.\n* Any gender.\n* The patient has not had resolution of their phantom limb pain with other treatments, such as a tricyclic antidepressant, or anticonvulsant medication.\n* No previous use of oral cannabinoids for pain management.\n\nExclusion Criteria:\n\n* The patient's pain is better explained by a treatable cause of stump pain, such as neuroma or bony overgrowth.\n* Gross abnormalities on routine baseline blood work including electrolytes, urea and creatinine, a complete blood count, and liver function tests (AST ALT GGT, Alk Phos, and LDH) that are twice the limit of normal. Normal tests taken within 3 months prior to the study will be accepted if there is no history of acute illness since the time the blood was drawn.\n* Heart disease. (Cannabinoids can reduce heart rate and blood pressure) Patients with heart disease will be excluded based on a history of symptomatic angina, MI or CHF as well as a clinical exam.\n* Schizophrenia or other Psychotic disorder\n* Severe liver dysfunction.\n* History of untreated non-psychotic emotional disorders.\n* Cognitive impairment.\n* Major illness in another body area.\n* Pregnancy.\n* Nursing mothers.\n* History of drug dependency.\n* A known sensitivity to marijuana or other cannabinoid agents"}, 'identificationModule': {'nctId': 'NCT00699634', 'briefTitle': 'Nabilone for the Treatment of Phantom Limb Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'A Randomized Double-blind Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Phantom Limb Pain', 'orgStudyIdInfo': {'id': '1975'}, 'secondaryIdInfos': [{'id': 'REB: B2007:129'}, {'id': 'Impact: RI07:119'}, {'id': 'Health Canada: 116697'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Nabilone', 'type': 'DRUG', 'otherNames': ['Cesemet'], 'description': 'Nabilone 0.5 mg at hs for 1 week, then 0.5 mg BID for 1 week. After a reassessment of the outcome measures, the dose is increased to 0.5 mg in the morning and 1 mg at hs for 1 week, followed by an increase to 1 mg BID in the last week of the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3A 1M4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Rehabilitation Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Ryan Q Skrabek, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Valeant Canada Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Ryan Quinlan Skrabek', 'oldOrganization': 'University of Manitoba'}}}}