Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04300751
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2020-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Behavioral Effects of Opioids and Alcohol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sharon.Walsh@uky.edu', 'phone': '859-257-6485', 'title': 'Director for the Center on Drug and Alcohol Research', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit.', 'description': 'AE definitions are the same as the clnicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-Intervention / Days Off', 'description': 'Prior to any drug administration or on participant days off when AE is not related to drug conditions.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Qualification: Oxycodone 30mg / Placebo', 'description': 'Prior to the experimental conditions, participants will receive a non-therapeutic dose of oxycodone 30 mg, p.o. during a qualifying day session. This session serves as a responsive challenge which is intended to confirm that subjects are able to detect the active drug.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Oxycodone 20mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Oxycodone 40mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Oxycodone 20mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Oxycodone 20mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Oxycodone 40mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Oxycodone 40mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized Body Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea / Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG001', 'title': 'Oxycodone 20mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG002', 'title': 'Oxycodone 40mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG003', 'title': 'Placebo/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG004', 'title': 'Placebo/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG005', 'title': 'Oxycodone 20mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG006', 'title': 'Oxycodone 20mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG007', 'title': 'Oxycodone 40mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG008', 'title': 'Oxycodone 40mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '49.9', 'spread': '7.9', 'groupId': 'OG002'}, {'value': '54.8', 'spread': '8.8', 'groupId': 'OG003'}, {'value': '61.2', 'spread': '8.2', 'groupId': 'OG004'}, {'value': '54.6', 'spread': '9.4', 'groupId': 'OG005'}, {'value': '66.9', 'spread': '9.4', 'groupId': 'OG006'}, {'value': '57.2', 'spread': '9.1', 'groupId': 'OG007'}, {'value': '72.9', 'spread': '7.2', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)', 'description': "Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the 9 experimental dosing conditions.'}, {'type': 'SECONDARY', 'title': 'Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG001', 'title': 'Oxycodone 20mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG002', 'title': 'Oxycodone 40mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG003', 'title': 'Placebo/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG004', 'title': 'Placebo/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG005', 'title': 'Oxycodone 20mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG006', 'title': 'Oxycodone 20mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG007', 'title': 'Oxycodone 40mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG008', 'title': 'Oxycodone 40mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '5.0', 'groupId': 'OG002'}, {'value': '41.2', 'spread': '7.6', 'groupId': 'OG003'}, {'value': '54', 'spread': '7.6', 'groupId': 'OG004'}, {'value': '39.6', 'spread': '8.3', 'groupId': 'OG005'}, {'value': '49.5', 'spread': '8.5', 'groupId': 'OG006'}, {'value': '33.4', 'spread': '8.2', 'groupId': 'OG007'}, {'value': '56.1', 'spread': '8.7', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)', 'description': 'Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants\' peak value was pulled from the raw data and averaged to yield one mean (SEM).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the 9 experimental dosing conditions.'}, {'type': 'SECONDARY', 'title': 'Trough Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG001', 'title': 'Oxycodone 20mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG002', 'title': 'Oxycodone 40mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG003', 'title': 'Placebo/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG004', 'title': 'Placebo/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG005', 'title': 'Oxycodone 20mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG006', 'title': 'Oxycodone 20mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG007', 'title': 'Oxycodone 40mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG008', 'title': 'Oxycodone 40mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '97.4', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '96.8', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '96.6', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '96.6', 'spread': '0.43', 'groupId': 'OG003'}, {'value': '96.2', 'spread': '0.30', 'groupId': 'OG004'}, {'value': '96.1', 'spread': '0.34', 'groupId': 'OG005'}, {'value': '95.7', 'spread': '0.30', 'groupId': 'OG006'}, {'value': '95.6', 'spread': '0.49', 'groupId': 'OG007'}, {'value': '95.2', 'spread': '0.47', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).', 'description': "Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM).", 'unitOfMeasure': 'Percentage of oxygen in blood', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the 9 experimental drug conditions.'}, {'type': 'SECONDARY', 'title': 'Peak Cold Pressor Test Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG001', 'title': 'Oxycodone 20mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG002', 'title': 'Oxycodone 40mg/Placebo', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG003', 'title': 'Placebo/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG004', 'title': 'Placebo/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG005', 'title': 'Oxycodone 20mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG006', 'title': 'Oxycodone 20mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG007', 'title': 'Oxycodone 40mg/Alcohol 0.5g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}, {'id': 'OG008', 'title': 'Oxycodone 40mg/Alcohol 0.8g/kg', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '30.2', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '32.4', 'groupId': 'OG002'}, {'value': '43.4', 'spread': '24.2', 'groupId': 'OG003'}, {'value': '60.6', 'spread': '31.7', 'groupId': 'OG004'}, {'value': '54.1', 'spread': '20.1', 'groupId': 'OG005'}, {'value': '73.2', 'spread': '31.9', 'groupId': 'OG006'}, {'value': '81.5', 'spread': '30.0', 'groupId': 'OG007'}, {'value': '98.9', 'spread': '30.9', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).', 'description': "Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).", 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the 9 experimental drug conditions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'The Behavioral Effects of Opioids and Alcohol', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Placebo/Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Oxycodone 20mg/Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Oxycodone 40mg/Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Placebo/Alcohol 0.5g/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Placebo/Alcohol 0.8g/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Oxycodone 20mg/Alcohol 0.5g/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Oxycodone 20mg/Alcohol 0.8g/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Oxycodone 40mg/Alcohol 0.5g/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Oxycodone 40mg/Alcohol 0.8g/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This is a crossover study with 9 conditions tested in random order in each completing subject.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Alcohol and Opioids', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.\n\nAlcohol: Active alcohol or placebo, administered orally\n\nOpioid Agonist: Active opioid agonist or placebo, administered orally'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.30', 'spread': '6.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', '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': '1', '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': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant did not complete the study. They left the study for non-study related reasons.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-02', 'size': 19294120, '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': '2025-10-13T15:28', '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, within-subjects design'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2020-03-05', 'resultsFirstSubmitDate': '2025-10-14', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-05', 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking', 'timeFrame': 'These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)', 'description': "Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM)."}], 'secondaryOutcomes': [{'measure': 'Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?', 'timeFrame': 'These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)', 'description': 'Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants\' peak value was pulled from the raw data and averaged to yield one mean (SEM).'}, {'measure': 'Trough Oxygen Saturation', 'timeFrame': 'Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).', 'description': "Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM)."}, {'measure': 'Peak Cold Pressor Test Threshold', 'timeFrame': 'Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).', 'description': "Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM)."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid', 'opiate', 'alcohol'], 'conditions': ['Opioid Use', 'Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'This study will examine the effects of doses of alcohol/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': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults ages 21-55\n* Current non-medical use of opioids\n* Previous alcohol use\n\nExclusion Criteria:\n\n* Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics\n* Seeking treatment for drug use\n* Significant medical problems'}, 'identificationModule': {'nctId': 'NCT04300751', 'briefTitle': 'The Behavioral Effects of Opioids and Alcohol', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Interactions of Alcohol and Opioids: Pharmacodynamic Effects', 'orgStudyIdInfo': {'id': '55176'}, 'secondaryIdInfos': [{'id': 'R01DA016718', 'link': 'https://reporter.nih.gov/quickSearch/R01DA016718', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol', 'description': 'Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.', 'interventionNames': ['Drug: Alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid Agonist', 'description': 'Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally', 'interventionNames': ['Drug: Opioid Agonist']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid Agonist/Alcohol Combination', 'description': 'Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.', 'interventionNames': ['Drug: Alcohol', 'Drug: Opioid Agonist']}], 'interventions': [{'name': 'Alcohol', 'type': 'DRUG', 'description': 'Active alcohol or placebo, administered orally', 'armGroupLabels': ['Alcohol', 'Opioid Agonist/Alcohol Combination']}, {'name': 'Opioid Agonist', 'type': 'DRUG', 'description': 'Active opioid agonist or placebo, administered orally', 'armGroupLabels': ['Opioid Agonist', 'Opioid Agonist/Alcohol Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Sharon L Walsh, 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': 'Sharon Walsh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the Center on Drug and Alcohol Research', 'investigatorFullName': 'Sharon Walsh', 'investigatorAffiliation': 'University of Kentucky'}}}}