Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-01 @ 11:02 PM
Study NCT ID:
NCT01397266
Status:
UNKNOWN
Last Update Posted:
2011-07-19
First Post:
2011-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-18', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Short PROMIS Questionnaire', 'timeFrame': '2 months', 'description': "The SPQ is a 160-question paper that counsellors and researchers can use to measure an individual's level of addictive tendency in each of sixteen distinct behavioural areas. Will be applied at the following times:\n\nT0 (weeks 0 - immediately prior to the rTMS) T1 (4 weeks, after four weeks of treatment with rTMS) and T2 (8 weeks, four weeks after completing treatment).\n\nThe improvement rate of 10% or more, will be our primary measure of efficacy. T0 ("}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transcranial Magnetic Stimulation', 'Cocaine', 'impulsivity', 'rating scale'], 'conditions': ['Cocaine Dependence']}, 'descriptionModule': {'briefSummary': 'In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.', 'detailedDescription': 'reduction of the rating impulsivity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).\n2. 20 days or less withdrawal\n3. 18-35 years old.\n4. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).\n5. Fixed residential address in Sao Paulo\n\nExclusion criteria:\n\n1. Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).\n2. organic brain disease, neurosurgery to implant metal clip or epilepsy.\n3. severe uncontrolled clinical comorbidity.\n4. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.\n5. Changes clinically significant laboratory findings. 13\n6. Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.\n7. Mandate that mandating the judicial treatment for cocaine dependence"}, 'identificationModule': {'nctId': 'NCT01397266', 'acronym': 'TMSCOCAINE', 'briefTitle': 'Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.', 'orgStudyIdInfo': {'id': '1339/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active TMS', 'description': 'active rTMS delivered to the left dorsolateral prefrontal cortex', 'interventionNames': ['Procedure: Transcranial Magnetic Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo TMS', 'description': 'PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex', 'interventionNames': ['Procedure: Placebo TMS']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', 'type': 'PROCEDURE', 'otherNames': ['TMS'], 'description': 'ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex', 'armGroupLabels': ['Active TMS']}, {'name': 'Placebo TMS', 'type': 'PROCEDURE', 'otherNames': ['TMS'], 'description': 'PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex', 'armGroupLabels': ['Placebo TMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ádan P JArdim', 'role': 'CONTACT', 'phone': '55 11 30698159'}, {'name': 'Ádan P Jardim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Ádan Jardim', 'role': 'CONTACT', 'phone': '+551130698159'}], 'overallOfficials': [{'name': 'Adan Jardim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence', 'oldOrganization': 'USaoPauloGH'}}}}