Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT00330434
Status:
WITHDRAWN
Last Update Posted:
2020-11-10
First Post:
2006-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2006-05-25', 'studyFirstSubmitQcDate': '2006-05-25', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol', 'Bupropion', 'Chlorzoxazone', 'Interaction', 'Induction', 'Depression', 'Smoking', 'Drinking', 'Cytochrome P450 Enzyme', 'CYP2B6', 'CYP2E1', 'Pharmacogenetics', 'Pharmacokinetics', 'Pharmacodynamics', 'Boston', 'Tufts University'], 'conditions': ['Alcohol Drinking', 'Depression', 'Smoking Cessation', 'Attention Deficit Disorder']}, 'referencesModule': {'references': [{'pmid': '10997936', 'type': 'BACKGROUND', 'citation': 'Hesse LM, Venkatakrishnan K, Court MH, von Moltke LL, Duan SX, Shader RI, Greenblatt DJ. CYP2B6 mediates the in vitro hydroxylation of bupropion: potential drug interactions with other antidepressants. Drug Metab Dispos. 2000 Oct;28(10):1176-83.'}, {'pmid': '15083067', 'type': 'BACKGROUND', 'citation': 'Hesse LM, He P, Krishnaswamy S, Hao Q, Hogan K, von Moltke LL, Greenblatt DJ, Court MH. Pharmacogenetic determinants of interindividual variability in bupropion hydroxylation by cytochrome P450 2B6 in human liver microsomes. Pharmacogenetics. 2004 Apr;14(4):225-38. doi: 10.1097/00008571-200404000-00002.'}]}, 'descriptionModule': {'briefSummary': 'The two purposes of this study are\n\n1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has\n\n 1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and\n 2. on the stimulant effect of bupropion and\n2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has\n\n 1. on the blood levels of bupropion and its major breakdown products in the blood and\n 2. on the stimulant effect of bupropion.\n\nTwo groups of volunteers will be recruited for this study:\n\n1. volunteers who drink moderate to heavy amounts of alcohol frequently and\n2. volunteers who usually do not drink alcohol.\n\nVolunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults who are 21 - 55 years of age.\n* Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol.\n\nExclusion Criteria:\n\n* Participants who are currently taking prescription medications (including oral contraceptives)\n* Pregnancy\n* Body mass index (BMI) greater than 30\n* History of seizures or eating disorders'}, 'identificationModule': {'nctId': 'NCT00330434', 'briefTitle': 'Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Human CYP2B6: Induction by Ethanol and Polymorphisms', 'orgStudyIdInfo': {'id': 'NIAAAGRE15647'}, 'secondaryIdInfos': [{'id': 'F32AA015647-01A1', 'link': 'https://reporter.nih.gov/quickSearch/F32AA015647-01A1', 'type': 'NIH'}, {'id': '1F32AA015647-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1F32AA015647-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Trial Withdrawn 2', 'description': 'Trial Withdrawn 2', 'interventionNames': ['Other: Trial Withdrawn 2']}, {'type': 'OTHER', 'label': 'Trial Withdrawn 1', 'description': 'Trial Withdrawn 1', 'interventionNames': ['Other: Trial Withdrawn 1']}], 'interventions': [{'name': 'Trial Withdrawn 1', 'type': 'OTHER', 'description': 'Trial Withdrawn 1', 'armGroupLabels': ['Trial Withdrawn 1']}, {'name': 'Trial Withdrawn 2', 'type': 'OTHER', 'description': 'Trial Withdrawn 2', 'armGroupLabels': ['Trial Withdrawn 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David J. Greenblatt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler School'}, {'name': 'Michael H. Court, BVsc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University, Department of Pharmacology and Experimental Therapeutics, Sackler School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}