Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 10:48 AM
Study NCT ID:
NCT00628706
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2008-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Acute Effects of THC on Functional Brain Systems
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2008-02-24', 'studyFirstSubmitQcDate': '2008-02-24', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main study parameter is the blood oxygen level dependent (BOLD) signal.', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Behavioral parameters (two VAS questionnaires)', 'timeFrame': '4 months'}, {'measure': 'Cerebral blood flow (ASL)', 'timeFrame': '4 months'}, {'measure': 'Concentration of plasma THC and its main metabolites', 'timeFrame': '4 months'}, {'measure': 'Performance on neuropsychological tests', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tetrahydrocannabinol', 'memory', 'reward', 'magnetic resonance imaging', 'endocannabinoids'], 'conditions': ['Reward', 'Tetrahydrocannabinol', 'Endocannabinoids', 'Memory', 'Magnetic Resonance Imaging']}, 'referencesModule': {'references': [{'pmid': '22066583', 'type': 'DERIVED', 'citation': 'Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF. Effects of Delta9-tetrahydrocannabinol administration on human encoding and recall memory function: a pharmacological FMRI study. J Cogn Neurosci. 2012 Mar;24(3):588-99. doi: 10.1162/jocn_a_00156. Epub 2011 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.', 'detailedDescription': 'Cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. Further, cannabis has an addictive potential. These effects are mediated by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1 receptors. These receptors are particularly highly expressed in brain regions involved in memory and reward. Therefore, in this study we will investigate the acute effects of THC on functional brain systems underlying memory and reward. We will visualize these effects using the latest non-invasive imaging technique: pharmacological MRI (phMRI).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of mild cannabis use for at least one year (\\<1/week and ≥ 4/year)\n* History without psychotic experiences after cannabis use\n* Age between 18 and 45 years\n* Right-handedness, assessed with the Edinburgh Handedness Inventory\n* Written informed consent of the subject\n\nExclusion Criteria:\n\n* Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening\n* Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests\n* History of clinically significant psychiatric or neurological illness\n* History of clinically significant psychiatric or neurological illness in first- or second-degree relatives\n* History of alcohol and/or drug abuse (DSM-IV criteria)\n* Body Mass Index (B.M.I.) \\<18 kg/m2 or \\>28 kg/m2\n* Paranoid ideation or psychoticism on SCL-90\n* Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug\n* The use of any medication within three weeks prior to the start of the study, except for paracetamol\n* Positive HIV or Hepatitis B/C test\n* Blood donation within 3 months before the start of the study\n* Claustrophobia\n* Metal objects in or around the body (braces, pacemaker, metal fragments)'}, 'identificationModule': {'nctId': 'NCT00628706', 'acronym': 'FIX', 'briefTitle': 'Investigating the Acute Effects of THC on Functional Brain Systems', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Investigating the Acute Effects of THC on Functional Brain Systems', 'orgStudyIdInfo': {'id': 'THC-phMRI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Inhalation of THC, using a Volcano vaporizer', 'interventionNames': ['Drug: Delta9-tetrahydrocannabinol (THC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Inhalation of vehicle, using a Volcano vaporizer', 'interventionNames': ['Drug: Delta9-tetrahydrocannabinol (THC)']}], 'interventions': [{'name': 'Delta9-tetrahydrocannabinol (THC)', 'type': 'DRUG', 'otherNames': ['dronabinol, marinol, THC, tetrahydrocannabinol'], 'description': 'inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Nick Ramsey, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Human Drug Research', 'class': 'UNKNOWN'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, {'name': 'TI Pharma', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. N.F. Ramsey', 'oldOrganization': 'UMC Utrecht'}}}}