Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-28 @ 10:24 PM
Study NCT ID:
NCT04871269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Intrusive Memories in the following four days after the intervention', 'timeFrame': 'four consecutive days', 'description': 'Influence of dronabinol on the development of intrusive memories measured with an intrusion diary'}], 'secondaryOutcomes': [{'measure': 'Noradrenergic System (measured with salivary alpha-amylase - u/ml)', 'timeFrame': 'Day 1', 'description': 'Influence of dronabinol on the noradrenergic system measured with salivary alpha-amylase'}, {'measure': 'Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)', 'timeFrame': 'Time Frame: Day 1', 'description': 'Influence of dronabinol on the HPA-axis measured with salivary cortisol'}, {'measure': 'Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories', 'timeFrame': 'Day 1', 'description': 'Influence of polygenic risk score on development of intrusive memories'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrusive Memories']}, 'descriptionModule': {'briefSummary': 'The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.\n\nA well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.\n\nThis project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.', 'detailedDescription': 'Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD) after traumatic events. In own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (AEA) in BPD patients compared to healthy women (see Fig 1a). Furthermore, we found a correlation between hair concentrations of AEA and cortisol (p = .06; Fig 1b).\n\nLow 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 (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.\n\nA well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.\n\nThis project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy female volunteers\n* German on a native level\n\nExclusion Criteria:\n\n* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)\n* any physical illnesses\n* any medication intake (except oral contraceptive)\n* history of traumatic experience, e.g. history of sexual abuse or rape\n* pregnancy or lactation period\n* follicular phase of menstrual cycle for all women not using oral contraceptives'}, 'identificationModule': {'nctId': 'NCT04871269', 'briefTitle': 'The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories', 'orgStudyIdInfo': {'id': 'DroMemo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: Dronabinol before the trauma film paradigm', 'interventionNames': ['Drug: Dronabinol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Drug: Dronabinol after the trauma film paradigm', 'interventionNames': ['Drug: Dronabinol', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo before and after the trauma film paradigm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dronabinol', 'type': 'DRUG', 'description': 'Dronabinol', 'armGroupLabels': ['Drug: Dronabinol after the trauma film paradigm', 'Drug: Dronabinol before the trauma film paradigm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Drug: Dronabinol after the trauma film paradigm', 'Drug: Dronabinol before the trauma film paradigm', 'Placebo before and after the trauma film paradigm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10249', 'city': 'Steglitz', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.45606, 'lon': 13.332}}], 'overallOfficials': [{'name': 'Stefan Röpke, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}, {'name': 'Katja Wingenfeld, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Stefan Roepke', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}