Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00069251
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2003-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bupropion for the Treatment of Methamphetamine Dependence - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019969', 'term': 'Amphetamine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2003-09-18', 'studyFirstSubmitQcDate': '2003-09-23', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity addiction'}, {'measure': 'Methamphetamine use'}]}, 'conditionsModule': {'keywords': ['amphetamine dependence'], 'conditions': ['Amphetamine-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence', 'detailedDescription': 'A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis\n* Subject must be willing to comply with study procedures.\n* Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures\n* Be able to comply with protocol requirements\n\nExclusion Criteria:\n\n* Please contact site for more information.'}, 'identificationModule': {'nctId': 'NCT00069251', 'briefTitle': 'Bupropion for the Treatment of Methamphetamine Dependence - 1', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Bupropion for the Treatment of Methamphetamine Dependence', 'orgStudyIdInfo': {'id': 'NIDA-CTO-0008-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bupropion', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92627', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Matrix Institute on Addictions', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92105', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'South Bay Treatment Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Pacific Addiction Research Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '50316', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Powell Chemical Dependency Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Richard Rawson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}}}}