Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00297505
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2006-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serotonin, Impulsivity, and Cocaine Dependence Treatment
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': 'D015283', 'term': 'Citalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'completionDateStruct': {'date': '2004-11'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2006-02-27', 'studyFirstSubmitQcDate': '2006-02-27', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of cocaine metabolites in urine weekly.'}], 'secondaryOutcomes': [{'measure': 'Retention rate and cocaine cravings weekly.'}]}, 'conditionsModule': {'keywords': ['Cocaine; citalopram; impulsivity; serotonin'], 'conditions': ['Cocaine Dependence']}, 'referencesModule': {'references': [{'pmid': '17613964', 'type': 'DERIVED', 'citation': 'Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78. doi: 10.1080/00952990701313686.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.', 'detailedDescription': 'Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.\n* female subjects: a negative pregnancy test\n\nExclusion Criteria:\n\n* current or past DSM-IV Axis I disorder other than substance abuse/dependence\n* any serious non-psychiatric medical illness requiring ongoing medical treatment\n* substance dependence other than cocaine within the last 3 months\n* negative urine drug screen for cocaine at time of testing\n* for female subjects: a positive pregnancy test'}, 'identificationModule': {'nctId': 'NCT00297505', 'briefTitle': 'Serotonin, Impulsivity, and Cocaine Dependence Treatment', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Serotonin, Impulsivity, and Cocaine Dependence Treatment', 'orgStudyIdInfo': {'id': 'R01DA008425', 'link': 'https://reporter.nih.gov/quickSearch/R01DA008425', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'citalopram', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Houston Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Frederick G Moeller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}}}}