Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-26 @ 9:56 AM
Study NCT ID:
NCT01980550
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2011-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-10', 'studyFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the exhaled carbon monoxide (CO) level during the 12-week study', 'timeFrame': 'The first was 1 day before quit day (baseline), followed by visits after 1, 2, 4, 6 and 8 weeks at the end of treatment (EOT), with a final follow-up visit at 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of sublingual nicotine tablets (SNT) for smoking cessation and the association of catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial among Chinese smokers.', 'detailedDescription': 'All subjects provided written informed consent after a full explanation of the protocol design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects motivated to stop smoking and Han Chinese\n* aged 20-70 years who lived in the Haidian District of Beijing\n* smoke ≥10 cigarettes/day\n* have smoked for ≥3 years\n* carbon monoxide (CO) level ≥10 p.p.m. in exhaled air\n\nExclusion Criteria:\n\n* a history of "Diagnostic and Statistical Manual of Mental Disorders-fourth Edition" (DSM-IV) psychiatric disorder\n* alcohol abuse and other drug abuse\n* with pathological changes in the floor of their mouth\n* cardiovascular disease\n* taking psychotropic medications\n* using other forms of tobacco or any other NRT products during the last 6 months\n* pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT01980550', 'briefTitle': 'Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'National Institute on Drug Dependence, China'}, 'officialTitle': 'Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy', 'orgStudyIdInfo': {'id': 'Hongqiang-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sublingual nicotine，placebo', 'description': 'sublingual nicotine：one or two tablets per hour, up to a maximum of 20 tablets per day Subjects were advised to use the full treatment dose for 4 weeks', 'interventionNames': ['Drug: sublingual nicotine']}], 'interventions': [{'name': 'sublingual nicotine', 'type': 'DRUG', 'otherNames': ['nicotine sublingual tablet'], 'description': 'The nicotine sublingual tablet is Smokers were recommended to use one or two tablets per hour, up to a maximum of 20 tablets per day. Subjects were advised to use the full treatment dose for 4 weeks. After this time-point, treatment could be tapered off up to the 8-week visit. During the next 4-week follow-up phase, no further medication was dispensed. Staff, who dispensed medications, were not involved in treating the subjects. During each patient visit, the importance of adequate dosing with study medication was emphasized. The medication was free of charge. In addition, all participants received six sessions of standardized behavioral group counseling focusing on self-monitoring and behavioral modification approaches.', 'armGroupLabels': ['sublingual nicotine，placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'xiang y zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center，USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Dependence, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bronx VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}