Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-08 @ 4:15 AM
Study NCT ID:
NCT04130633
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Behavioral Pharmacology of THC and Alpha-pinene
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'C587251', 'term': 'nabiximols'}, {'id': 'C005451', 'term': 'alpha-pinene'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'czamarr2@jh.edu', 'phone': '410-550-6969', 'title': 'C. Austin Zamarripa, PhD', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 hours post dose', 'description': 'International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo (5mL distilled water)\n\nPlacebo: Placebo vapor (distilled water)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vaporized High Alpha-pinene', 'description': '15mg of vaporized alpha-pinene\n\nAlpha-Pinene: Pure alpha-pinene vapor', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vaporized High THC Alone', 'description': '30mg of vaporized pure THC\n\nTHC: Pure THC vapor', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vaporized High THC and Low Alpha-pinene', 'description': '30mg vaporized THC with 0.5mg of vaporized alpha-pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Vaporized High THC and Mid-dose Alpha-pinene', 'description': '30mg vaporized THC with 5.0mg of vaporized alpha-pinene with\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Vaporized High THC and High Alpha-pinene', 'description': '30mg of vaporized pure THC and 15mg alpha- pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 4, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheaded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (5mL distilled water)\n\nPlacebo: Placebo vapor (distilled water)'}, {'id': 'OG001', 'title': 'Vaporized High Alpha-pinene', 'description': '15mg of vaporized alpha-pinene\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG002', 'title': 'Vaporized High THC Alone', 'description': '30mg of vaporized pure THC\n\nTHC: Pure THC vapor'}, {'id': 'OG003', 'title': 'Vaporized High THC and Low Alpha-pinene', 'description': '30mg vaporized THC with 0.5mg of vaporized alpha-pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG004', 'title': 'Vaporized High THC and Mid-dose Alpha-pinene', 'description': '30mg vaporized THC with 5.0mg of vaporized alpha-pinene with\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG005', 'title': 'Vaporized High THC and High Alpha-pinene', 'description': '30mg of vaporized pure THC and 15mg alpha- pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '67.2', 'spread': '27.4', 'groupId': 'OG002'}, {'value': '66.1', 'spread': '35.1', 'groupId': 'OG003'}, {'value': '61.5', 'spread': '37.0', 'groupId': 'OG004'}, {'value': '62.9', 'spread': '38.0', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.', 'description': 'Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Represents study completers'}, {'type': 'PRIMARY', 'title': 'Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (5mL distilled water)\n\nPlacebo: Placebo vapor (distilled water)'}, {'id': 'OG001', 'title': 'Vaporized High Alpha-pinene', 'description': '15mg of vaporized alpha-pinene\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG002', 'title': 'Vaporized High THC Alone', 'description': '30mg of vaporized pure THC\n\nTHC: Pure THC vapor'}, {'id': 'OG003', 'title': 'Vaporized High THC and Low Alpha-pinene', 'description': '30mg vaporized THC with 0.5mg of vaporized alpha-pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG004', 'title': 'Vaporized High THC and Mid-dose Alpha-pinene', 'description': '30mg vaporized THC with 5.0mg of vaporized alpha-pinene with\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG005', 'title': 'Vaporized High THC and High Alpha-pinene', 'description': '30mg of vaporized pure THC and 15mg alpha- pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '-12.6', 'spread': '16.9', 'groupId': 'OG002'}, {'value': '-11.2', 'spread': '13.2', 'groupId': 'OG003'}, {'value': '-8.2', 'spread': '11.9', 'groupId': 'OG004'}, {'value': '-11.1', 'spread': '15.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.', 'description': 'Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Represents study completers'}, {'type': 'PRIMARY', 'title': 'Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (5mL distilled water)\n\nPlacebo: Placebo vapor (distilled water)'}, {'id': 'OG001', 'title': 'Vaporized High Alpha-pinene', 'description': '15mg of vaporized alpha-pinene\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG002', 'title': 'Vaporized High THC Alone', 'description': '30mg of vaporized pure THC\n\nTHC: Pure THC vapor'}, {'id': 'OG003', 'title': 'Vaporized High THC and Low Alpha-pinene', 'description': '30mg vaporized THC with 0.5mg of vaporized alpha-pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG004', 'title': 'Vaporized High THC and Mid-dose Alpha-pinene', 'description': '30mg vaporized THC with 5.0mg of vaporized alpha-pinene with\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}, {'id': 'OG005', 'title': 'Vaporized High THC and High Alpha-pinene', 'description': '30mg of vaporized pure THC and 15mg alpha- pinene\n\nTHC: Pure THC vapor\n\nAlpha-Pinene: Pure alpha-pinene vapor'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '-8.7', 'spread': '13.7', 'groupId': 'OG002'}, {'value': '-5.1', 'spread': '14.7', 'groupId': 'OG003'}, {'value': '-5.7', 'spread': '11.8', 'groupId': 'OG004'}, {'value': '-7.5', 'spread': '12.9', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.', 'description': 'Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Represents study completers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaporized Delta-9-tetrahydrocannabinol (THC) With and Without Alpha-Pinene', 'description': 'Participants vaporized THC and pinene in a within-subject crossover design:\n\n1. Placebo\n2. High Pinene (15mg)\n3. High THC (30mg)\n4. High THC (30mg) and Low Pinene (0.5mg)\n5. High THC (30mg) and Mid dose Pinene (5mg)\n6. High THC (30mg and High Pinene (15mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '15 mg Alpha-pinene', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': '30mg THC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '30mg THC / 0.5mg Pinene', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': '30mg THC / 5mg Pinene', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': '30mg THC / 15mg Pinene', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaporized THC With and Without Pinene', 'description': 'All study completers completed the following 6 conditions in a randomized order:\n\n1. Placebo\n2. High Pinene (15mg)\n3. High THC (30mg)\n4. High THC (30mg) and Low Pinene (0.5mg)\n5. High THC (30mg) and Mid dose Pinene (5mg)\n6. High THC (30mg and High Pinene (15mg)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.57', 'spread': '8.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', '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': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study completers are reported. 19 participants completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-18', 'size': 617340, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-08T15:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'placebo controlled, double-blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants will complete all dose conditions (study arms) in a randomized order'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2019-10-16', 'resultsFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-20', 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)', 'timeFrame': '0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.', 'description': 'Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.'}, {'measure': 'Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)', 'timeFrame': '0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.', 'description': 'Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).'}, {'measure': 'Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)', 'timeFrame': '0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.', 'description': 'Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['THC', 'Alpha-pinene']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized alpha-pinene and THC administered via inhalation.', 'detailedDescription': 'The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 6 acute drug administration periods in which they will administer THC alone, pinene alone, THC and pinene together, or placebo. Subjective drug effects, cognitive performance, and vital signs will be assessed following drug administration. Each participant will receive all 6 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help the investigators understand the individual and interactive effects of THC and pinene, two common constituents found in cannabis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have provided written informed consent\n* Be between the ages of 18 and 55\n* Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests\n* Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission\n* Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.\n* Have a body mass index (BMI) in the range of 18 to 36 kg/m2\n* Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg\n* Have no allergies to any of the ingredients used to prepare vapor (THC, pinene).\n* Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score of 75/90).\n\nExclusion Criteria:\n\n* Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;\n* History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.\n* Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.\n* Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.\n* Use of dronabinol (Marinol®) within the past month.\n* Average use of cannabis more than 2 times per week in the prior 3 months.\n* History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).\n* Abnormal EKG result that in the investigator's opinion is clinically significant.\n* Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.\n* Having previously sought medical attention to manage adverse effects following acute cannabis use.\n* Individuals with anemia or who have donated blood in the prior 30 days"}, 'identificationModule': {'nctId': 'NCT04130633', 'briefTitle': 'Behavioral Pharmacology of THC and Alpha-pinene', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Behavioral Pharmacology of THC and Alpha-pinene', 'orgStudyIdInfo': {'id': 'IRB00182689'}, 'secondaryIdInfos': [{'id': 'R01DA043475', 'link': 'https://reporter.nih.gov/quickSearch/R01DA043475', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (5mL distilled water)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized Pinene', 'description': '15mg vaporized alpha-pinene', 'interventionNames': ['Drug: Alpha-Pinene']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized THC', 'description': '30mg vaporized delta-9-THC', 'interventionNames': ['Drug: THC']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized THC and low alpha-pinene', 'description': '30mg vaporized delta-9-THC and 0.5mg of vaporized alpha-pinene', 'interventionNames': ['Drug: THC', 'Drug: Alpha-Pinene']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized THC and alpha-pinene', 'description': '30mg vaporized delta-9-THC and 5mg of vaporized alpha-pinene', 'interventionNames': ['Drug: THC', 'Drug: Alpha-Pinene']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized THC and high alpha-pinene', 'description': '30mg vaporized delta-9-THC and 15mg of vaporized alpha-pinene', 'interventionNames': ['Drug: THC', 'Drug: Alpha-Pinene']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo vapor (distilled water)', 'armGroupLabels': ['Placebo']}, {'name': 'THC', 'type': 'DRUG', 'otherNames': ['Cannabis', 'Delta-9-THC'], 'description': 'Pure THC vapor', 'armGroupLabels': ['Vaporized THC', 'Vaporized THC and alpha-pinene', 'Vaporized THC and high alpha-pinene', 'Vaporized THC and low alpha-pinene']}, {'name': 'Alpha-Pinene', 'type': 'DRUG', 'otherNames': ['Pinene'], 'description': 'Pure alpha-pinene vapor', 'armGroupLabels': ['Vaporized Pinene', 'Vaporized THC and alpha-pinene', 'Vaporized THC and high alpha-pinene', 'Vaporized THC and low alpha-pinene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ryan Vandrey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}