Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-17 @ 4:52 AM
Study NCT ID:
NCT02061020
Status:
COMPLETED
Last Update Posted:
2016-06-09
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-08', 'studyFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to drive a motor vehicle measured using a driving simulator', 'timeFrame': '0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h', 'description': 'The association between THC blood concentrations and driving performances as measured by deviations from the centre of the road and variations of speed at 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h after smoking.'}], 'secondaryOutcomes': [{'measure': 'Psychomotor Vigilance Test (PVT) measures', 'timeFrame': '0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h', 'description': 'The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours'}, {'measure': 'THC pharmacokinetics of occasional and chronic users over 24 hours', 'timeFrame': '24 hours', 'description': 'THC pharmacokinetics parameters (AUC, T1/2, CMAX) of occasional and chronic users over 24 hours will be modelled using a population nonlinear mixed approach.'}, {'measure': '24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3', 'timeFrame': '24 hours', 'description': '24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 \\* 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['delta-9-tetrahydrocannabinol, volunteers, cannabis users'], 'conditions': ['Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users']}, 'referencesModule': {'references': [{'pmid': '38074719', 'type': 'DERIVED', 'citation': 'Hartley S, Simon N, Cardozo B, Larabi IA, Alvarez JC. Can inhaled cannabis users accurately evaluate impaired driving ability? A randomized controlled trial. Front Public Health. 2023 Nov 22;11:1234765. doi: 10.3389/fpubh.2023.1234765. eCollection 2023.'}, {'pmid': '33386756', 'type': 'DERIVED', 'citation': 'Alvarez JC, Hartley S, Etting I, Ribot M, Derridj-Ait-Younes N, Verstuyft C, Larabi IA, Simon N. Population pharmacokinetic model of blood THC and its metabolites in chronic and occasional cannabis users and relationship with on-site oral fluid testing. Br J Clin Pharmacol. 2021 Aug;87(8):3139-3149. doi: 10.1111/bcp.14724. Epub 2021 Jan 12.'}, {'pmid': '30872375', 'type': 'DERIVED', 'citation': 'Hartley S, Simon N, Larabi A, Vaugier I, Barbot F, Quera-Salva MA, Alvarez JC. Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. Clin Chem. 2019 May;65(5):684-693. doi: 10.1373/clinchem.2018.299727. Epub 2019 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.', 'detailedDescription': 'This study will examine:\n\n* The relationship between THC blood levels and driving performance measured on a York Driving simulator\n* The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT)\n* the pharmacokinetics of THC in occasional and chronic cannabis consumers\n* Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed\n* Determine whether the polymorphism of CYP2C9 (\\* 3) is associated with the AUC, Cmax, and higher THC T1/2\n* Determine if the polymorphism of CYP2C9 (\\* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy volunteer of male gender from 18 to 25 years\n* Normal medical examination\n* Driving license owner\n* BMI between 18.5 and 25\n* moderate tobacco consumption\n* moderate consumption of coffee, tea, cola (≤ 225mg caffeine per day)\n* Cannabis user for at least 1 year\n* Occasional (1-2 joints per week) or chronic (1-2 joints per day) cannabis consumers\n* Availability during the study\n* Signed consent\n\nExclusion criteria:\n\n* Participation in another clinical study\n* Having taken any psychotropic medication in the past one month\n* Having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than THC in the past 3 days (negative urinary test at inclusion)\n* Alcohol blood level positive at inclusion\n* Excessive alcohol consumption (AUDIT score \\> 7)\n* Dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic)\n* Depression\n* Sleep disorders\n* Any psychiatric history, including psychosis\n* Deprived of their liberty by judicial or administrative decision\n* Lack of medical insurance\n* Professional use of motorized vehicles'}, 'identificationModule': {'nctId': 'NCT02061020', 'acronym': 'VIGICANN', 'briefTitle': 'Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users', 'orgStudyIdInfo': {'id': 'AOR12144 / P111114'}, 'secondaryIdInfos': [{'id': '2013-A00245-40', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': '1. THC containing cigarettes 10mg\n2. THC containing cigarettes 30mg\n3. Placebo', 'interventionNames': ['Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': '1. THC containing cigarettes 30mg\n2. Placebo\n3. THC containing cigarettes 10mg', 'interventionNames': ['Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': '1. Placebo\n2. THC containing cigarettes 10mg\n3. THC containing cigarettes 30mg', 'interventionNames': ['Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo']}], 'interventions': [{'name': 'Cannabis (THC) in cigarettes of 30mg, 10mg and placebo', 'type': 'DRUG', 'description': 'Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo.\n\nBoth chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco.\n\nEach cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0).\n\nBlood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Raymond Poincare Hospital', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Sarah Hartley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sleep Disorders Unit - Raymond Poincaré Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}