Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-04-24 @ 7:00 PM
Study NCT ID:
NCT02751359
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zcooper@mednet.ucla.edu', 'phone': '310-206-9942', 'title': 'Dr. Ziva Cooper, Principal Investigator', 'organization': 'University of California Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During and after each study session, average of 4 weeks total study participation', 'eventGroups': [{'id': 'EG000', 'title': 'Active CBD 200 mg', 'description': 'Cannabidiol: 200mg', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active CBD 400 mg', 'description': 'Cannabidiol: 400mg', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Active CBD 800 mg', 'description': 'Cannabidiol: 800mg', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)\n\nPlacebo: 0 mg Cannabidiol', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gas and cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subtle mood change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequent urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wooziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active CBD 200 mg', 'description': 'Cannabidiol: 200mg'}, {'id': 'OG001', 'title': 'Active CBD 400 mg', 'description': 'Cannabidiol: 400mg'}, {'id': 'OG002', 'title': 'Active CBD 800 mg', 'description': 'Cannabidiol: 800mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)\n\nPlacebo: 0 mg Cannabidiol'}], 'classes': [{'title': 'Threshold', 'categories': [{'measurements': [{'value': '9.7', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Tolerance', 'categories': [{'measurements': [{'value': '5.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '9.6', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose', 'description': 'Time to first feel pain ("Pain threshold" measured in seconds) during the Cold Pressor Test and withdraw the hand from the cold water ("Pain Tolerance" measured in seconds). Changes in threshold from baseline were averaged across study sessions for each CBD dose.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active CBD 200 mg', 'description': 'Cannabidiol: 200mg'}, {'id': 'OG001', 'title': 'Active CBD 400 mg', 'description': 'Cannabidiol: 400mg'}, {'id': 'OG002', 'title': 'Active CBD 800 mg', 'description': 'Cannabidiol: 800mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)\n\nPlacebo: 0 mg Cannabidiol'}], 'classes': [{'title': 'Good effect', 'categories': [{'measurements': [{'value': '8.7', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '13.3', 'spread': '5.7', 'groupId': 'OG003'}]}]}, {'title': 'Bad effect', 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '2.5', 'groupId': 'OG003'}]}]}, {'title': 'Drug liking', 'categories': [{'measurements': [{'value': '18.7', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '5.1', 'groupId': 'OG002'}, {'value': '18.8', 'spread': '6.1', 'groupId': 'OG003'}]}]}, {'title': 'Desire to take again', 'categories': [{'measurements': [{'value': '17.9', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '5.9', 'groupId': 'OG002'}, {'value': '17.5', 'spread': '6.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes', 'description': "Participants rate the strength of their desire to take again, drug liking, good effect and bad effect. Each item was presented and the participant was asked to rate his / her rating on a scale anchored by 'Not At All' (0 mm) to 'Extremely' (100 mm). The average of all timepoints is reported for each category.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Group - Repeated Measures', 'description': 'Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Group - Repeated Measures', 'description': 'Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Demographics were collected for study completers'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-23', 'size': 287652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-14T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2016-04-12', 'resultsFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-19', 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test', 'timeFrame': 'Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose', 'description': 'Time to first feel pain ("Pain threshold" measured in seconds) during the Cold Pressor Test and withdraw the hand from the cold water ("Pain Tolerance" measured in seconds). Changes in threshold from baseline were averaged across study sessions for each CBD dose.'}], 'secondaryOutcomes': [{'measure': 'Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales', 'timeFrame': '30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes', 'description': "Participants rate the strength of their desire to take again, drug liking, good effect and bad effect. Each item was presented and the participant was asked to rate his / her rating on a scale anchored by 'Not At All' (0 mm) to 'Extremely' (100 mm). The average of all timepoints is reported for each category."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this double-blind, placebo-controlled study is to determine the analgesic effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics.', 'detailedDescription': 'This within-subject, double-blind, placebo-controlled study will assess the analgesic and subjective effects of a range of CBD doses (0, 200, 400, or 800 mg, po). Volunteers will participate in 4 outpatient laboratory sessions over the course of 4 weeks during which the analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics. The order of CBD dose will be randomized across participants. Secondary measures will include subjective and physiologic effects of CBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to perform study procedures\n* Women practicing an effective form of birth control\n\nExclusion Criteria:\n\n* Female subjects who are currently pregnant or breastfeeding.\n* Current illicit drug use\n* Presence of significant medical illness\n* History of heart disease\n* Request for drug treatment\n* Current parole or probation\n* Recent history of significant violent behavior\n* Major psychiatric disorder\n* Current use of any prescription or over-the-counter medication\n* Current pain\n* Clinically significant Raynaud's syndrome"}, 'identificationModule': {'nctId': 'NCT02751359', 'briefTitle': 'Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers', 'orgStudyIdInfo': {'id': '7009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active CBD', 'description': 'Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study days. The active cannabidiol doses include 200, 400 and 800 mg of cannabidiol.', 'interventionNames': ['Drug: Cannabidiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cannabidiol', 'type': 'DRUG', 'otherNames': ['CBD'], 'description': '200, 400, or 800 mg Cannabidiol', 'armGroupLabels': ['Active CBD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0 mg Cannabidiol', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10013', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cooper', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ziva D Cooper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute / CUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSYS Therapeutics Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Neurobiology (in Psychiatry)', 'investigatorFullName': 'Ziva D. Cooper, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}