Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT06081218
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015197', 'term': 'Carcinogenicity Tests'}], 'ancestors': [{'id': 'D018675', 'term': 'Toxicity Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma endocannabinoids levels (pmol/ml)', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'regulating hormone of endocannabinoids (plasma levels of cortisol, ng/ml)', 'timeFrame': '2 weeks'}, {'measure': 'Blood marker of neurogenesis and neuroplasticity (plasma levels and BDNF, pg/ml)', 'timeFrame': '2 weeks'}, {'measure': 'change in cerebral muscular, oxygenation (HHB), (HbO2), (Hbtot) (arbitrary unit)', 'timeFrame': '2 weeks'}, {'measure': 'Cognitive function (selective attention, stroop test)', 'timeFrame': '2 weeks', 'description': "The stroop test can be used to measure a person's selective attention capacity"}, {'measure': 'Oxygen consumption (VO2) (ml/min/kg)', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis User']}, 'descriptionModule': {'briefSummary': 'The endocannabinoid system (ECS) is a complex endogenous signaling system made up of transmembrane cannabinoid receptors (CB1 and CB2 receptors), their endogenous lipid-derived ligands (the endocannabinoids - eCBs), and enzymes for ligand biosynthesis and degradation. Interestingly, exercise increase plasma AEA, one of the most famous endocannabinoid. This increase could be involved in exercise-induced neurogenesis and other beneficial exercise adaptations. Chronic cannabis use is associated with alteration of ECS activity. The aim of the study is to compare ECS response to exercise between chronic cannabis users and non-users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCannabis consumer group:\n\n* Cannabis consumption \\> 100 times in lifetime, last exposure \\< 7 days, and recent exposure \\> 10 times in the month.\n* Positive toxicological urine test for ∆-9-THC.\n* Having a cannabis use disorder according to the CAST.\n\nHealthy group:\n\n* Negative urine toxicological test for cannabis.\n* No regular cannabis use for more than 6 months once in a lifetime.\n* No cannabis consumption in the 6 months preceding the study.\n\nExclusion Criteria:\n\nFor all subjects :\n\n* Disorders of use of other substances (alcohol, cocaine, opioid, or synthetic drugs).\n* Alcohol consumption greater than 30g per day (averaged over one week) and/or alcohol abuse the week preceding the visit.\n* Under medical treatment.\n* Presence of diagnosed neurological disorders.\n* Diagnosis of a psychotic picture entering axis I, DSM-5.\n* Chronic progressive disease or in remission.\n* Body mass index \\> 30 kg/m2 (i.e. presence of obesity).'}, 'identificationModule': {'nctId': 'NCT06081218', 'acronym': 'CANNABEX', 'briefTitle': 'Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users', 'orgStudyIdInfo': {'id': '2016_70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic cannabis users', 'interventionNames': ['Other: activity test']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy subjects', 'interventionNames': ['Other: activity test']}], 'interventions': [{'name': 'activity test', 'type': 'OTHER', 'description': 'Over 2 weeks, participants have to do a maximal progressive exercise and a 30 min constant exercise at 50% of maximal aerobic power', 'armGroupLabels': ['Chronic cannabis users', 'Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'COTTENCIN Olivier', 'role': 'CONTACT', 'email': 'Olivier.COTTENCIN@chu-lille.fr'}, {'name': 'GAMELIN François-Xavier, PhD', 'role': 'CONTACT', 'email': 'francois-xavier.gamelin@univ-lille.fr', 'phone': '06.26.19.23.09'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Olivier Cottencin, MD,PhD', 'role': 'CONTACT', 'email': 'olivier.cottencin@chru-lille.fr', 'phone': '0320445962'}, {'name': 'Francois-xavier Gamelin, PhD', 'role': 'CONTACT', 'email': 'francois-xavier.gamelin@univ-lille.fr', 'phone': '06.26.19.23.09', 'phoneExt': '0033'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}