Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-26 @ 12:06 PM
Study NCT ID:
NCT00495092
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2007-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}, {'id': 'D001712', 'term': 'Biperiden'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001643', 'term': 'Bridged Bicyclo Compounds'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2007-06-29', 'studyFirstSubmitQcDate': '2007-06-29', 'lastUpdatePostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.', 'timeFrame': '12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cocaine dependence', 'cocaine use', 'cocaine craving'], 'conditions': ['Cocaine Related Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the efficacy of caffeine compared to placebo in detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also studied.\n\n108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 6 months.\n\nPrimary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology, craving for cocaine and mental status during detoxifying period, 2) study retention and 3) cocaine use.\n\nBrain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of intranasal cocaine dependence, according to DSM-IV-TR criteria\n* age between 18 and 60 years\n* current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.\n* demonstrated capacity to grant informed consent and sign the pertinent informed consent form.\n* place of residence compatible with attendance at the centre.\n* for women, willingness to use effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* diagnosis of a severe medical disorder that could interfere with the study\n* presence of an organic pathology for which methylxanthines or biperidene, iodine or apomorphine administration is contraindicated\n* serum liver transaminase levels 3 times higher than normal values\n* pregnancy and breast-feeding\n* neuroleptic medication treatment in the past 6 weeks\n* current treatment, or anticipation that the patient may need to initiate treatment during the study with drugs that may interact with study medication.\n* current diagnosis of a major mental disorder.\n* awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)\n* current participation in another research project."}, 'identificationModule': {'nctId': 'NCT00495092', 'briefTitle': 'Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients', 'orgStudyIdInfo': {'id': 'CAF-DTX-1'}, 'secondaryIdInfos': [{'id': 'INT/71525/2003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'This study arm will receive caffeine+placebo', 'interventionNames': ['Drug: Caffeine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'this study arm will receive Caffeine+Biperiden', 'interventionNames': ['Drug: Caffeine', 'Drug: Biperiden']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'this study arm will receive placebo+placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Caffeine', 'type': 'DRUG', 'description': 'Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d', 'armGroupLabels': ['1', '2']}, {'name': 'Biperiden', 'type': 'DRUG', 'description': 'Biperiden 2-4 mg/d p.o.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo + Placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Miquel Casas, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Miguel Casas Brugué', 'oldOrganization': "Servei de Psiquiatria. Hospital Universitari Vall d'Hebron"}}}}