Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-26 @ 11:44 AM
Study NCT ID:
NCT05226351
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activation of the Endocannabinoid System and Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'blinding'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extinction learning', 'timeFrame': '30 minutes', 'description': 'extinction learning in fear conditioning paradigm: skin conductance reaction'}], 'secondaryOutcomes': [{'measure': 'empathy', 'timeFrame': '15 minutes', 'description': 'cognitive and emotional empathy: number of correct answers \\& rating of own emotional state'}, {'measure': 'Probabilistic Reversal Learning Task', 'timeFrame': '15 minutes', 'description': 'learning and cognitive flexibility: reaction times'}, {'measure': 'selective attention', 'timeFrame': '10 minutes', 'description': 'emotional dot-probe task: attentional bias index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.', 'detailedDescription': 'Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD criteria fullfilled (patients only)\n\nExclusion Criteria:\n\n* All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded.\n* Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded.\n* psychiatric disorder according to DSM-5 (healthy controls only)'}, 'identificationModule': {'nctId': 'NCT05226351', 'acronym': 'DronaMemo-2', 'briefTitle': 'Activation of the Endocannabinoid System and Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)', 'orgStudyIdInfo': {'id': 'WI 3396/14-1 // RO 3935/7-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dronabinol PTSD', 'description': 'Donabinol before cognitve testing - PTSD patients', 'interventionNames': ['Drug: Dronabinol 2.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dronabinol healthy controls', 'description': 'Donabinol before cognitve testing - healthy controls', 'interventionNames': ['Drug: Dronabinol 2.5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo PTSD', 'description': 'Placebo before cognitve testing - PTSD patients', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo healthy controls', 'description': 'Placebo before cognitve testing - healthy controls', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dronabinol 2.5 mg', 'type': 'DRUG', 'description': 'single administration of 2.5mg Dronabinol oral (oily solution)', 'armGroupLabels': ['Dronabinol PTSD', 'Dronabinol healthy controls']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single administration of placebo oral (oily solution)', 'armGroupLabels': ['Placebo PTSD', 'Placebo healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Stefan Röpke', 'investigatorFullName': 'Stefan Roepke', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}