Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00701532
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2008-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077408', 'term': 'Modafinil'}, {'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}, {'id': 'D059906', 'term': 'Neuroimaging'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-10', 'studyFirstSubmitDate': '2008-06-18', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.', 'timeFrame': 'day 3 and day of cocaine detoxification'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal.', 'timeFrame': 'D3 to D90'}, {'measure': 'Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.', 'timeFrame': 'D3 to D21'}, {'measure': 'Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.', 'timeFrame': 'D3 to D21'}, {'measure': 'Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.', 'timeFrame': 'D3 to D90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cocaine', 'Substance abuse', 'Addiction', 'Dependence', 'Modafinil', 'Brain imaging'], 'conditions': ['Cocaine Addiction', 'Cocaine Dependence']}, 'descriptionModule': {'briefSummary': '-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.\n\nPrimary Hypothesis:\n\nMore rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during cocaine detoxification.', 'detailedDescription': "Context:\n\nCocaine dependence is a disorder with a rapidly progressive evolution, associated with various complications. Because of cocaine's direct action on the dopamine transporter (DAT), dopaminergic system dysregulation plays a fundamental role in reinforcement phenomenon and in dependence. This has been proven in numerous animal and post-death human studies of striatal DAT. In vivo studies in cocaine dependent patients are rare. Currently no pharmacotherapy is available to treat this pathology. Current studies indicate that pharmacological agents such as modafinil may be able to reverse the neuroadaptations induced by cocaine dependence. However, no functional neuroimaging study (Positron Emission Tomography, PET) has analysed the impact of medications on DAT density in cocaine dependent patients. However, in primates, in vivo PET has shown modafinil affinity for DAT.\n\nPrimary Hypothesis:\n\nMore rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during therapeutic cocaine withdrawal.\n\nStudy objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.\n\nSecondary:\n\nEvaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal. Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.\n\nStudy of DAT from D3 to D21 versus a pre-existing data base of control subjects.\n\nTolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.\n\nCalculation of the number of subjects: A power of 90% is found for a number of subjects estimated at 24 (bilateral test, α risk at 5%, estimated SEM of 5%, variation of the occupational concentration of the DAT expected to be at least 12% in the modafinil group). Considering the usual rate of patients lost to follow-up in this patient population (25%), we plan to include 30 patients.\n\nMethodology: This study is regulated by the law on biomedical research of August 9, 2004. It is a randomised monocentric double blind study versus placebo. During the study, for 90 days, patients will receive in double blind either modafinil or placebo according to their randomisation arm.\n\nEvaluations will include 2 PET, cerebral MRI, blood work-up, urinary toxin screen, clinical scales for craving, depression and neuropsychological evaluations.\n\nPatients will be recruited over 24 months. The total study length will be 36 months.\n\nPrimary judgment criteria: Variation of the linking potentials (specific fixation rate for the radioligand \\[11C\\]-PE2I to DAT) between the TEP measurement on D3 and D21 within the various anatomical region of interest between the 2 groups (modafinil, placebo).\n\nExpected Results: Decreased DAT occupation rates in the modafinil group versus placebo from D3 to D21 of withdrawal."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men of at least 18 years of age\n* Cocaine dependent according to DSM IV TR criteria\n* Seeking treatment\n* Capable of understanding and giving their informed written consent\n* With National Health coverage\n* Urinary screen positive for cocaine in the weeks prior to inclusion\n\nExclusion Criteria:\n\n* Women\n* Other DSM IV TR axe I diagnostic criteria (except for tobacco)\n* Neurological disorders\n* Treatment that interferes with the DAT and modafinil\n* Contraindications for modafinil and Magnetic Resonance Imaging'}, 'identificationModule': {'nctId': 'NCT00701532', 'acronym': 'CAIMAN', 'briefTitle': 'Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study', 'orgStudyIdInfo': {'id': 'P070150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'active', 'interventionNames': ['Drug: Modafinil and PET (brain imaging)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Modafinil and PET (brain imaging)', 'type': 'DRUG', 'description': 'duration 90 days', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'duration 90 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91401', 'city': 'Orsay', 'country': 'France', 'facility': 'Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot', 'geoPoint': {'lat': 48.69572, 'lon': 2.18727}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': "Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse", 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Michel Reynaud, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}