Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-22 @ 2:05 AM
Study NCT ID:
NCT00572234
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bupropion in the Treatment of Methamphetamine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathleen.grant2@va.gov', 'phone': '402-995-4347', 'title': 'Kathleen Grant', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Receiving Bupropion SR', 'description': 'receiving bupropion SR\n\nbupropion SR: 12 week course of bupropion SR 150 mg, BID', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': 'Not receiving bupropion', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Receiving Bupropion SR', 'description': 'receiving bupropion SR 12 week course of bupropion SR 150 mg, BID\n\nbupropion SR: 12 week course of bupropion SR 150 mg, BID'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Not receiving bupropion'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed Methamphetamine use at weeks 12 and 24, week 24 reported', 'description': 'The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were per protocol and based on number of participants enrolled in study who were not withdrawn from the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Receiving Bupropion (Sustain Release) SR', 'description': 'receiving bupropion SR\n\nbupropion SR: 12 week course of bupropion SR 150 mg, (twice a day) BID'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': 'Not receiving bupropion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Dates of recruitment: August 31, 2007 - April 6, 2010 Recruitment from residential substance use disorder treatment programs in Omaha and Lincoln, Nebraska.', 'preAssignmentDetails': 'Initially participants were assigned to one of two randomization pools: one group with and one group without psychoses. However as of January 30, 2009 no participants met criteria for randomization to the psychosis arm of the study and the protocol was changed to remove the psychosis randomization pool.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Receiving Bupropion SR', 'description': 'receiving bupropion SR\n\nbupropion SR: 12 week course of bupropion SR 150 mg, BID'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': 'Not receiving bupropion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '34', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '34', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2011-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2007-12-11', 'resultsFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-24', 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.', 'timeFrame': 'Assessed Methamphetamine use at weeks 12 and 24, week 24 reported', 'description': 'The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methamphetamine', 'Bupropion SR (Sustained Release)'], 'conditions': ['Methamphetamine Use Disorder']}, 'descriptionModule': {'briefSummary': 'Methamphetamine dependence is a significant drug use disorder in the Midwest. While a number of psychosocial and pharmacological treatments have been studied, no specific treatments for methamphetamine have been identified. This study is a collaborative pre-clinical and clinical partnership examining bupropion in the treatment of methamphetamine dependence.', 'detailedDescription': "Nearly 40% of adults seeking substance use disorders (SUD) treatment in Nebraska report methamphetamine is their drug of choice. In preliminary studies examining bupropion in methamphetamine use, it was well tolerated, reduced craving for methamphetamine and reduced methamphetamine related euphoria. Investigators at the University of Nebraska Medical Center and the University of Nebraska-Lincoln have initiated studies examining bupropion in animals and humans as a potential intervention in addictive disorders. Pre-clinical studies in the Co-Investigator's laboratory were the first to demonstrate the potential utility of bupropion as a pharmacotherapy for methamphetamine use disorders (MUD) while the Principal Investigator studied bupropion as a smoking cessation aid in alcoholics.\n\nThe primary goal of this study is to establish an interdisciplinary and translational collaboration to test bupropion in persons in treatment for methamphetamine dependence and to inform pre-clinical studies so as to enhance their practical applicability to clinical settings. The pilot clinical study will examine the treatment effect and safety of a 12 week course of bupropion in persons with methamphetamine use disorder. Concurrently, we will examine the efficacy of bupropion on methamphetamine self-administration in animal models which better simulates clinical approaches."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient in the substance use disorder program at either the Omaha VA Medical Center or at Catholic Charities Campus for Hope\n* diagnosis of methamphetamine dependence as well as presence or history of psychosis based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria (not to include patients in full sustained remission)\n* provide names, addresses, and phone numbers of at least two collateral informants who can provide information on their methamphetamine and other drug use during follow-up\n* must sign an informed consent as approved by the UNMC Internal Review Board (IRB) and Catholic Charities Research Committee.\n\nExclusion Criteria:\n\n* a history of severe injury to their brain\n* advanced cardiac, pulmonary, renal or liver disease\n* predisposition to seizures\n* history of bulimia or anorexia nervosa\n* current diagnosis of major depressive disorder\n* diagnosis or past history of panic disorders, schizophrenia, or bipolar affective disorder\n* family history or childhood history of epilepsy or seizures\n* history of strokes, brain tumors, or bleeding in the brain.\n* used any psychoactive drug within one week of study entry (two weeks for MAO (monoamine oxidase) inhibitors or protriptyline, four weeks for fluoxetine)\n* currently using any theophylline product (e.g. Theodur)\n* used an investigational drug in any study within the past four weeks\n* used a therapeutic course of bupropion SR for \\> 1 week at any time in the past 12 months or have been evaluated in previous studies examining bupropion SR at anytime\n* If female, the participant must not be pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT00572234', 'briefTitle': 'Bupropion in the Treatment of Methamphetamine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Bupropion in the Treatment of Methamphetamine Dependence', 'orgStudyIdInfo': {'id': '0260-07-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving Bupropion SR', 'description': 'receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day)', 'interventionNames': ['Drug: bupropion SR']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'Not receiving bupropion'}], 'interventions': [{'name': 'bupropion SR', 'type': 'DRUG', 'description': '12 week course of bupropion SR 150 mg, BID', 'armGroupLabels': ['Receiving Bupropion SR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68104', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Catholic Charities Campus for Hope', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center, Omaha', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Kathleen M Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veterans Affairs Medical Center, Omaha'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}