Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT00696033
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Effects of Diazepam and Lorazepam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003975', 'term': 'Diazepam'}, {'id': 'D008140', 'term': 'Lorazepam'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2008-06-09', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI', 'timeFrame': 'After a single oral intake'}], 'secondaryOutcomes': [{'measure': 'Comparing lorazepam effects to diazepam (0.3 mg/kg)effects', 'timeFrame': 'After a single oral intake'}, {'measure': 'Exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI', 'timeFrame': 'After single oral intake'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benzodiazepines', 'Lorazepam', 'Diazepam', 'Memory', 'Perceptual priming', 'Functional brain imaging', 'FMRI'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Aims :\n\n* exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI\n* comparing lorazepam effects to diazepam (0.3 mg/kg)effects\n* exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI\n\nHypothesis :\n\n* both diazepam and lorazepam will impair explicit memory performance, but lorazepam only will impair perceptual priming\n* lorazepam and diazepam will modify the normal correlates of information encoding within explicit memory\n* lorazepam only will alter the neural correlates of perceptual priming'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects between 18 and 30 years\n* Students in medicine, dentistry or pharmacy\n* French as a mother language\n\nExclusion criteria:\n\n* Medical condition influencing brain function (neurological or psychiatric)\n* Asthma\n* General anesthesia in the 3 last months\n* Drug addiction (DSM IV criteria)\n* Regular medical treatment (except contraceptive pill)\n* Significant impairment observed during a medical examination including ECG\n* Intake of any psychotropic drug that can have a effect during testing\n* IQ (Wechsler) \\< 100\n* FMRI contra-indication (implantable magnetic material, claustrophobia)\n* Known allergy to benzodiazepine or lactose\n* \\> 10 cigarettes/day\n* Pregnant or breast-feeding woman\n* No health insurance\n* Subjects who do not complete the entire study'}, 'identificationModule': {'nctId': 'NCT00696033', 'acronym': 'ibid', 'briefTitle': 'Exploring the Effects of Diazepam and Lorazepam', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers', 'orgStudyIdInfo': {'id': '3777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Oral Lorazepam', 'interventionNames': ['Drug: Lorazepam']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Oral Diazepam', 'interventionNames': ['Drug: Diazepam']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Oral placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Diazepam', 'type': 'DRUG', 'description': 'Diazépam drug (0,3 mg/kg) on a single oral intake', 'armGroupLabels': ['2']}, {'name': 'Lorazepam', 'type': 'DRUG', 'description': 'Lorazépam drug (0,038 mg/kg) on a single oral intake', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'lorazépam placebo or Diazépam placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Centre d'investigation clinique, hôpital civil", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Clinique psychiatrique, hôpital civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Pierre Vidailhet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}