Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-05-23 @ 11:44 AM
Study NCT ID:
NCT03705559
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2018-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Opioid and Cannabinoid Interactions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}, {'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'babalonis@uky.edu', 'phone': '859-257-1881', 'title': 'Shanna Babalonis, Ph. D.', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'THC 10mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'THC 30mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Oxycodone 15mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Oxycodone 30mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'TCH 10mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'TCH 10mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'TCH 30mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'TCH 30mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Subject-Rated Outcome - VAS Drug Liking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG001', 'title': 'THC 10mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG002', 'title': 'THC 30mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG003', 'title': 'Oxycodone 15mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG004', 'title': 'Oxycodone 30mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG005', 'title': 'TCH 10mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG006', 'title': 'TCH 10mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG007', 'title': 'TCH 30mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG008', 'title': 'TCH 30mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '53.33', 'spread': '10.03', 'groupId': 'OG001'}, {'value': '58.89', 'spread': '9.09', 'groupId': 'OG002'}, {'value': '38.78', 'spread': '8.29', 'groupId': 'OG003'}, {'value': '35.22', 'spread': '8.54', 'groupId': 'OG004'}, {'value': '48.67', 'spread': '10.68', 'groupId': 'OG005'}, {'value': '48.00', 'spread': '8.82', 'groupId': 'OG006'}, {'value': '65.22', 'spread': '8.02', 'groupId': 'OG007'}, {'value': '72.11', 'spread': '8.04', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.', 'description': 'Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the experimental drug conditions.'}, {'type': 'SECONDARY', 'title': 'Change in Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG001', 'title': 'THC 10mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG002', 'title': 'THC 30mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG003', 'title': 'Oxycodone 15mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG004', 'title': 'Oxycodone 30mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG005', 'title': 'TCH 10mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG006', 'title': 'TCH 10mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG007', 'title': 'TCH 30mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG008', 'title': 'TCH 30mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '96.56', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '96.44', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '96.44', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '96.44', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '96.11', 'spread': '0.11', 'groupId': 'OG004'}, {'value': '96.22', 'spread': '0.15', 'groupId': 'OG005'}, {'value': '96.28', 'spread': '0.30', 'groupId': 'OG006'}, {'value': '95.83', 'spread': '0.31', 'groupId': 'OG007'}, {'value': '96.00', 'spread': '0.19', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.', 'description': 'Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.', 'unitOfMeasure': 'percentage of oxygen saturation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the experimental drug conditions.'}, {'type': 'SECONDARY', 'title': 'Change in Respiration Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG001', 'title': 'THC 10mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG002', 'title': 'THC 30mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG003', 'title': 'Oxycodone 15mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG004', 'title': 'Oxycodone 30mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG005', 'title': 'TCH 10mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG006', 'title': 'TCH 10mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG007', 'title': 'TCH 30mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG008', 'title': 'TCH 30mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '11.89', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '11.44', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '12.44', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '11.22', 'spread': '0.60', 'groupId': 'OG003'}, {'value': '10.22', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '10.89', 'spread': '0.35', 'groupId': 'OG005'}, {'value': '10.44', 'spread': '0.44', 'groupId': 'OG006'}, {'value': '10.56', 'spread': '0.53', 'groupId': 'OG007'}, {'value': '10.89', 'spread': '0.42', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.', 'description': 'Respiration rate (number of breaths per minute). Raw data transformed to trough scores.', 'unitOfMeasure': 'number of breaths per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the experimental drug conditions.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG001', 'title': 'THC 10mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG002', 'title': 'THC 30mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG003', 'title': 'Oxycodone 15mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG004', 'title': 'Oxycodone 30mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG005', 'title': 'TCH 10mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG006', 'title': 'TCH 10mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG007', 'title': 'TCH 30mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG008', 'title': 'TCH 30mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '133.56', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '134.06', 'spread': '3.50', 'groupId': 'OG001'}, {'value': '140.56', 'spread': '3.72', 'groupId': 'OG002'}, {'value': '136.33', 'spread': '3.98', 'groupId': 'OG003'}, {'value': '134.33', 'spread': '3.36', 'groupId': 'OG004'}, {'value': '138.11', 'spread': '2.87', 'groupId': 'OG005'}, {'value': '139.39', 'spread': '3.27', 'groupId': 'OG006'}, {'value': '147.04', 'spread': '5.26', 'groupId': 'OG007'}, {'value': '147.56', 'spread': '4.46', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.', 'description': 'Systolic blood pressure (mm Hg). Raw data transformed to peak scores.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the experimental drug conditions.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG001', 'title': 'THC 10mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG002', 'title': 'THC 30mg/Placebo Opioid', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG003', 'title': 'Oxycodone 15mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG004', 'title': 'Oxycodone 30mg/Placebo Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).\n\nOpioid Agonist: Active Opioid Agonist administered intranasally\n\nPlacebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)'}, {'id': 'OG005', 'title': 'TCH 10mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG006', 'title': 'TCH 10mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG007', 'title': 'TCH 30mg/Oxycodone 15mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}, {'id': 'OG008', 'title': 'TCH 30mg/Oxycodone 30mg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.\n\nVaporized Marijuana: Active Marijuana administered through vaporizer\n\nOpioid Agonist: Active Opioid Agonist administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '89.44', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '97.18', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '94.92', 'spread': '2.47', 'groupId': 'OG002'}, {'value': '94.08', 'spread': '1.59', 'groupId': 'OG003'}, {'value': '91.78', 'spread': '1.78', 'groupId': 'OG004'}, {'value': '91.83', 'spread': '2.46', 'groupId': 'OG005'}, {'value': '92.67', 'spread': '2.51', 'groupId': 'OG006'}, {'value': '95.94', 'spread': '2.22', 'groupId': 'OG007'}, {'value': '98.72', 'spread': '3.48', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.', 'description': 'Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the experimental drug conditions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Opioid and Cannabinoid Interactions', 'description': 'Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active opioids.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Placebo/Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'THC 10mg/Placebo Opioid', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'THC 30mg/Placebo Opioid', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Oxycodone 15mg/Placebo Marijuana', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Oxycodone 30mg/Placebo Marijuana', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'TCH 10mg/Oxycodone 15mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'TCH 10mg/Oxycodone 30mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'TCH 30mg/Oxycodone 15mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'TCH 30mg/Oxycodone 30mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'COVID Shut down', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Unique, randomized dose orders were created for each participant. The study utilized a within-subject design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Opioid and Cannabinoid Interactions', 'description': 'Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active opioids.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.78', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', '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': '9', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', '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': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Per protocol population. Defined as participants completing the experimental drug conditions.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-22', 'size': 11962679, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-02-05T10:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This is a randomized, double-blind, double-dummy, placebo-controlled design'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2018-10-03', 'resultsFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-24', 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Subject-Rated Outcome - VAS Drug Liking', 'timeFrame': 'This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.', 'description': 'Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.'}], 'secondaryOutcomes': [{'measure': 'Change in Oxygen Saturation', 'timeFrame': 'Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.', 'description': 'Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.'}, {'measure': 'Change in Respiration Rate', 'timeFrame': 'Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.', 'description': 'Respiration rate (number of breaths per minute). Raw data transformed to trough scores.'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.', 'description': 'Systolic blood pressure (mm Hg). Raw data transformed to peak scores.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.', 'description': 'Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['marijuana', 'opioid', 'opiate', 'cannabis'], 'conditions': ['Marijuana Usage', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults ages 18-50\n* Current non-medical use of opioids and marijuana\n\nExclusion Criteria:\n\n* Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics\n* Seeking treatment for drug use\n* Significant medical problems'}, 'identificationModule': {'nctId': 'NCT03705559', 'briefTitle': 'Opioid and Cannabinoid Interactions', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Interactions of Marijuana and Opioids: Pharmacodynamic Effects', 'orgStudyIdInfo': {'id': '45017'}, 'secondaryIdInfos': [{'id': 'R01DA045700', 'link': 'https://reporter.nih.gov/quickSearch/R01DA045700', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaporized Marijuana', 'description': 'Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.', 'interventionNames': ['Drug: Vaporized Marijuana', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid Agonist', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).', 'interventionNames': ['Drug: Opioid Agonist', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid Agonist/Marijuana Combination', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.', 'interventionNames': ['Drug: Vaporized Marijuana', 'Drug: Opioid Agonist']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vaporized Marijuana', 'type': 'DRUG', 'otherNames': ['Cannabis', 'THC'], 'description': 'Active Marijuana administered through vaporizer', 'armGroupLabels': ['Opioid Agonist/Marijuana Combination', 'Vaporized Marijuana']}, {'name': 'Opioid Agonist', 'type': 'DRUG', 'otherNames': ['Oxycodone'], 'description': 'Active Opioid Agonist administered intranasally', 'armGroupLabels': ['Opioid Agonist', 'Opioid Agonist/Marijuana Combination']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)', 'armGroupLabels': ['Opioid Agonist', 'Placebo', 'Vaporized Marijuana']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Shanna Babalonis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have no plans to share individual participant data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanna Babalonis, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shanna Babalonis, PhD', 'investigatorAffiliation': 'University of Kentucky'}}}}