Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT06014606
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2022-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Learning and Decision-making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D011433', 'term': 'Propranolol'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double-blind (randomised) between-subjects design'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physiology I', 'timeFrame': 'pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration', 'description': 'Heart rate'}, {'measure': 'Physiology II', 'timeFrame': 'pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration', 'description': 'blood pressure'}], 'primaryOutcomes': [{'measure': 'Cost-benefit reinforcement learning performance', 'timeFrame': '~ 2.5 hours post-drug administration', 'description': '2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)'}], 'secondaryOutcomes': [{'measure': 'Effort-based decision-making', 'timeFrame': '~ 2 hours post-drug administration', 'description': 'motivation to acquire rewards (e.g., Reddy et al. 2015)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motivation']}, 'referencesModule': {'references': [{'pmid': '35065334', 'type': 'RESULT', 'citation': 'Voulgaropoulou SD, Fauzani F, Pfirrmann J, Vingerhoets C, van Amelsvoort T, Hernaus D. Asymmetric effects of acute stress on cost and benefit learning. Psychoneuroendocrinology. 2022 Apr;138:105646. doi: 10.1016/j.psyneuen.2021.105646. Epub 2021 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'A fundamental aspect of daily life decision-making involves the evaluation of costs and benefits. Neural systems underlying cost-benefit evaluation have been extensively examined, but the specific role of different neurotransmitters remains unclear. Numerous studies suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement learning, guided exploration/exploitation, and behavioural energisation, although no studies to date have investigated the distinct role of DA and NE on cost-benefit decision-making and learning in human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to sign an informed consent\n* Age between 18 and 35\n* Body-Mass Index (BMI) between 17.5-30\n* Availability for participation through the duration of the study\n\nExclusion Criteria:\n\n* Diagnosis of a psychiatric or neurological disorder, including substance abuse or dependence (yes/no self-report - lifetime)\n* Use of any psychopharmacological treatment 3 weeks before the test day (yes/no self-report)\n* Use of any blood pressure medication (yes/no self-report - lifetime)\n* Pregnancy (confirmed via urine pregnancy test) or nursing (yes/no self-report) or have plans to get pregnant in the near future (yes/no self-report) (females only)\n* Diagnosis of a cardiac disease (medical questionnaire), obstructive respiratory disease (medical questionnaire), abnormal blood pressure (diastolic\\< 60mmHg; systolic\\< 90mmHg) (medical screening)\n* Chronic renal failure (medical questionnaire)\n* Hypothyroidism (medical questionnaire)\n* Diabetes (medical questionnaire)\n* Hypersensitivity to phenothiazines (medical questionnaire)\n* Diagnosis of a cardiac disease (medical questionnaire)\n* Alcohol consumption in the 24 hours before the test session starts (yes/no self-report)\n* Food intake less than 3 hours before the test day (yes/no self-report)'}, 'identificationModule': {'nctId': 'NCT06014606', 'briefTitle': 'Learning and Decision-making', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'How Does the Brain Learn About Positive and Negative Things?', 'orgStudyIdInfo': {'id': 'DANE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'HV/Placebo', 'description': 'Oral placebo (tablet)', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HV/Haloperidol', 'description': '2mg (oral)', 'interventionNames': ['Drug: haloperidol 2mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HV/Propranolol', 'description': '40mg (oral)', 'interventionNames': ['Drug: propranolol 40mg']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'oral formulation', 'armGroupLabels': ['HV/Placebo']}, {'name': 'haloperidol 2mg', 'type': 'DRUG', 'description': 'oral formulation', 'armGroupLabels': ['HV/Haloperidol']}, {'name': 'propranolol 40mg', 'type': 'DRUG', 'description': 'oral formulation', 'armGroupLabels': ['HV/Propranolol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}