Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-25 @ 5:36 AM
Study NCT ID:
NCT01595620
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2012-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabinoid Modulation of Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004560', 'term': 'Electricity'}, {'id': 'D002211', 'term': 'Capsaicin'}, {'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2012-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capsaicin-induced hyperalgesia', 'timeFrame': 'On each test day at baseline (-30), peak (+20) and post (+120) drug administration'}], 'secondaryOutcomes': [{'measure': 'Pain Measures', 'timeFrame': 'On each test day at baseline (-30), peak (+20) and post (+120) drug administration'}, {'measure': 'Non-pain subjective responses', 'timeFrame': 'On each test day at baseline (-30), peak (+20) and post (+120) drug administration'}, {'measure': 'Cognitive subjective responses', 'timeFrame': 'On each test day at baseline (-30), peak (+20) and post (+120) drug administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cannabis', 'THC', 'Pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one lifetime exposure to cannabis\n* Acceptable Birth Control methods for females\n\nExclusion Criteria:\n\n* Cannabis naive\n* Medical or psychiatric contraindications\n* Analgesic medication\n* Previous sensitivity to THC or cannabis'}, 'identificationModule': {'nctId': 'NCT01595620', 'briefTitle': 'Cannabinoid Modulation of Pain', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Cannabinoid Modulation of Pain', 'orgStudyIdInfo': {'id': '1005006859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'THC 0.01 mg/kg', 'interventionNames': ['Other: Thermal', 'Other: Electrical', 'Other: Capsaicin', 'Drug: THC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Thermal', 'Other: Electrical', 'Other: Capsaicin', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'THC 0.03 mg/kg', 'interventionNames': ['Other: Thermal', 'Other: Electrical', 'Other: Capsaicin', 'Drug: THC']}], 'interventions': [{'name': 'Thermal', 'type': 'OTHER', 'description': 'Thermal sensation/pain testing', 'armGroupLabels': ['Placebo', 'THC 0.01 mg/kg', 'THC 0.03 mg/kg']}, {'name': 'Electrical', 'type': 'OTHER', 'description': 'Electrical sensation/pain testing', 'armGroupLabels': ['Placebo', 'THC 0.01 mg/kg', 'THC 0.03 mg/kg']}, {'name': 'Capsaicin', 'type': 'OTHER', 'description': 'Intradermal Capsaicin', 'armGroupLabels': ['Placebo', 'THC 0.01 mg/kg', 'THC 0.03 mg/kg']}, {'name': 'THC', 'type': 'DRUG', 'otherNames': ['Delta-9-tetrahydrocannabinol'], 'description': 'Active THC (0.01 mg/kg) administered over 10 minutes', 'armGroupLabels': ['THC 0.01 mg/kg']}, {'name': 'THC', 'type': 'DRUG', 'otherNames': ['Delta-9-tetrahydrocannabinol'], 'description': 'Active THC (0.03 mg/kg) administered over 10 minutes', 'armGroupLabels': ['THC 0.03 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Control: small amount of alcohol with no THC, administered over 10 minutes', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': "Deepak C D'Souza, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Deepak C. D'Souza", 'investigatorAffiliation': 'Yale University'}}}}