Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:01 AM
Study NCT ID:
NCT01149018
Status:
UNKNOWN
Last Update Posted:
2010-06-23
First Post:
2010-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-22', 'studyFirstSubmitDate': '2010-06-22', 'studyFirstSubmitQcDate': '2010-06-22', 'lastUpdatePostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Meaningful change in Brief Pain Inventory average pain severity.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Tetrahydrocannabinol', 'Chronic Widespread Pain'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult (\\>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria\n\nExclusion Criteria:\n\n\\- Children \\< 18 years old\n\nPatients with following psychiatric disorders:\n\n* Psychosis or history of acute psychosis\n* Schizophrenia\n* Bipolar disorder Patients smoking marijuana, using hashish or any other form of cannabis. Patients with history of drug abuse or illicit drug use Patients receiving chronic treatment with strong opioids (Morphine, Oxycodone, Fentanyl, Methadone, Hydromorphone, Buprenorphine, Pethidine). Weak opioids as Tramadol or Propoxyphene will be allowed.\n\nPregnant patients'}, 'identificationModule': {'nctId': 'NCT01149018', 'briefTitle': 'Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'THC-FMS-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tetrahydrocannabinol', 'interventionNames': ['Drug: Tetrahydrocannabinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tetrahydrocannabinol', 'type': 'DRUG', 'description': 'Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.', 'armGroupLabels': ['Tetrahydrocannabinol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Pain Relief Unit, Hadassah Medical Organisation', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Elyad Davidson, MD', 'role': 'CONTACT', 'phone': '+972 2677 6911'}, {'name': 'Simon Haroutiunian, M.Sc', 'role': 'CONTACT', 'email': 'simonh@ekmd.huji.ac.il', 'phone': '+972 2677 6770'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Elyad Davidson, MD', 'oldOrganization': 'Hadassah Medical Organization'}}}}