Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT04036968
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2019-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Medication-based Analgesia in Humans- STUDY 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kdunn9@jhmi.edu', 'phone': '410-550-2254', 'title': 'Kelly Dunn, Professor', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 40 hours', 'description': 'Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 8, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hydromorphone+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 20, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 50mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 15, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 100mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 22, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 200mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 20, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appetite Decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appetite Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clumsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Euphoria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Light Headed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shaky', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photosensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Piloerection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequent Urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Cold Pressor Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG001', 'title': 'Hydromorphone+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG002', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 50mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG003', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 100mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG004', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 200mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '118.6', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '130.8', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '161.1', 'spread': '10.1', 'groupId': 'OG002'}, {'value': '163.2', 'spread': '9.9', 'groupId': 'OG003'}, {'value': '154.6', 'spread': '9.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.195', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of three drug conditions with cannabidiol to control groups placebo+placebo and hydromorphone+placebo'}], 'paramType': 'MEAN', 'timeFrame': '8 hour study session', 'description': 'Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG001', 'title': 'Hydromorphone+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG002', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 50mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG003', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 100mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG004', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 200mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '18.0', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '17.9', 'spread': '1.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 hour study session', 'description': 'Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Number Accurate on Circular Lights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG001', 'title': 'Hydromorphone+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG002', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 50mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG003', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 100mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}, {'id': 'OG004', 'title': 'Hydromorphone (Oral) 4mg + Cannabidiol 200mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.\n\nWithin-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '64.1', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '63.6', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '64.3', 'spread': '0.9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 hour study session', 'description': 'Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task.', 'unitOfMeasure': 'correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Full Participant Sample', 'description': 'Each participant completed the following five study conditions (arms) in randomized order:\n\nPlacebo + Placebo condition\n\nHydromorphone (oral) 4mg + placebo condition\n\nHydromorphone (oral) 4mg + Cannabidiol (oral) 50mg condition\n\nHydromorphone (oral) 4mg + Cannabidiol (oral) 100mg condition\n\nHydromorphone (oral) 4mg + Cannabidiol (oral) 200mg condition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Placebo + Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Hydromorphoe 4mg + Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Hydromorphone 4mg + Cannabidiol 50mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Hydromorphone 4mg + Cannabidiol 100mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Hydromorphone 4mg + Cannabidiol 200mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This is a within-subject study, and all participants (n=31) completed all study conditions. The same 31 participants moved from one treatment arm to the next.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'This is a within group study and same participants went through all treatment arms.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', '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': '7', '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': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', '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': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-18', 'size': 1676608, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-31T12:16', 'hasProtocol': True}, {'date': '2021-11-01', 'size': 365719, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-31T12:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study drug administration will be concealed from all study staff and participants to prevent bias in outcomes.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Within-subject study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2019-07-25', 'resultsFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-15', 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Cold Pressor Tolerance', 'timeFrame': '8 hour study session', 'description': 'Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300).'}, {'measure': 'Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale', 'timeFrame': '8 hour study session', 'description': 'Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects.'}, {'measure': 'Peak Number Accurate on Circular Lights', 'timeFrame': '8 hour study session', 'description': 'Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Trial', 'Analgesia', 'Phase II', 'Abuse potential'], 'conditions': ['Pain', 'Cannabis', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '40839659', 'type': 'DERIVED', 'citation': 'Bergeria CL, Mun CJ, Speed TJ, Huhn AS, Wolinsky D, Vandrey R, Campbell CM, Dunn KE. A within-subject, double-blind, placebo-controlled randomized evaluation of the combined effects of cannabidiol and hydromorphone in a human laboratory pain model. Pain. 2025 Feb 28;166(9):e175-e184. doi: 10.1097/j.pain.0000000000003561.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.', 'detailedDescription': 'This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75\n* Urine sample tests negative for common illicit substances of abuse, including cannabis\n* Medically cleared to take study medications\n* Are not pregnant or breast feeding\n* Willing to comply with the study protocol.\n\nExclusion Criteria:\n\n* Meet DSM-5 criteria for alcohol/substance use disorder\n* Taking opioids for pain\n* Previous adverse reaction to a cannabinoid product\n* Prescribed and taking stimulants or benzodiazepines\n* Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain\n* Self-report any illicit drug or cannabinoid use in the past 7 days\n* Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event\n* History of seizure disorder\n* Have a known allergy to the study medications or sesame seed oil\n* ALT or AST levels \\>3x ULN and/or Bilirubin levels \\>2x ULN during Screening\n* Current (past 60-day) suicidal thoughts or past year history of suicidal behavior\n* Taking medications contraindicated with hydromorphone or cannabidiol\n* Have a history of clinically significant cardiac arrhythmias or vasopastic disease\n* Have an abnormal and clinically-significant ECG'}, 'identificationModule': {'nctId': 'NCT04036968', 'briefTitle': 'Enhancing Medication-based Analgesia in Humans- STUDY 2', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evaluating Cannabidiol (CBD) to Enhance the Analgesic Effect of Hydromorphone in Humans', 'orgStudyIdInfo': {'id': 'IRB00214289'}, 'secondaryIdInfos': [{'id': 'R01DA040644', 'link': 'https://reporter.nih.gov/quickSearch/R01DA040644', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.', 'interventionNames': ['Drug: Within-subject test of blinded study medications']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydromorphone+Placebo', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.', 'interventionNames': ['Drug: Within-subject test of blinded study medications']}, {'type': 'EXPERIMENTAL', 'label': 'Hydromorphone (oral) 4mg + Cannabidiol 50mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.', 'interventionNames': ['Drug: Within-subject test of blinded study medications']}, {'type': 'EXPERIMENTAL', 'label': 'Hydromorphone (oral) 4mg + Cannabidiol 100mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.', 'interventionNames': ['Drug: Within-subject test of blinded study medications']}, {'type': 'EXPERIMENTAL', 'label': 'Hydromorphone (oral) 4mg + Cannabidiol 200mg', 'description': 'Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.', 'interventionNames': ['Drug: Within-subject test of blinded study medications']}], 'interventions': [{'name': 'Within-subject test of blinded study medications', 'type': 'DRUG', 'description': 'Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.', 'armGroupLabels': ['Hydromorphone (oral) 4mg + Cannabidiol 100mg', 'Hydromorphone (oral) 4mg + Cannabidiol 200mg', 'Hydromorphone (oral) 4mg + Cannabidiol 50mg', 'Hydromorphone+Placebo', 'Placebo+Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University Bayview Medical Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Kelly E Dunn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Claudia Campbell, 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'}}}}