Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 1:18 PM
Study NCT ID:
NCT00793468
Status:
WITHDRAWN
Last Update Posted:
2016-02-15
First Post:
2008-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relapse Prevention Study in Newly Abstinent Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594007', 'term': 'GSK598809'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study halted prior to enrollment of patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-11', 'studyFirstSubmitDate': '2008-11-18', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous smoking abstinence', 'timeFrame': 'weeks 13 through 16'}], 'secondaryOutcomes': [{'measure': 'safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events', 'timeFrame': 'weeks 1 through 16 and follow-up phase'}, {'measure': 'Weekly point prevalence abstinence', 'timeFrame': 'Weeks 6, 8, 10, 12, 14, and 16'}, {'measure': 'drug exposure level', 'timeFrame': 'weeks 6-16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nicotine dependence', 'smoking', 'pharmacological treatment', 'relapse prevention'], 'conditions': ['Substance Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of GSK598809 as compared to placebo in preventing recently-quit smokers from going back to smoking.', 'detailedDescription': 'The primary objective of this study is to evaluate the efficacy of GSK598809 compared to placebo for the prevention of relapse to smoking in recently abstinent smokers. Subjects who meet eligibility criteria will enter a 4-week open label treatment period during which they will receive nicotine replacement therapy (NRT). Subjects who have achieved at least one week of abstinence during the last week of an open label treatment period will be randomized to either GSK598809 or placebo in the double-blind treatment period and followed for another 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* has smoked at least 10 cigarettes a day for at least 2 years\n* has had multiple previous attempts to quit smoking and relapsed to smoking.\n* generally healthy\n\nExclusion Criteria:\n\n* cannot be using smokeless tobacco of any type or has tried to quit with medicine.\n* does not abuse alcohol or drugs\n* certain emotional problems being treated with medications\n* pregnant or breast feeding female'}, 'identificationModule': {'nctId': 'NCT00793468', 'briefTitle': 'Relapse Prevention Study in Newly Abstinent Smokers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.', 'orgStudyIdInfo': {'id': '108428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.', 'interventionNames': ['Drug: GSK598809', 'Drug: Nicotine Replacement Transdermal Patch', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GSK598809 Arm', 'description': 'Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.', 'interventionNames': ['Drug: GSK598809', 'Drug: Nicotine Replacement Transdermal Patch']}], 'interventions': [{'name': 'GSK598809', 'type': 'DRUG', 'description': 'GSK598809 once daily for 12 weeks', 'armGroupLabels': ['GSK598809 Arm', 'Placebo Arm']}, {'name': 'Nicotine Replacement Transdermal Patch', 'type': 'DRUG', 'description': 'All subjects will be treated during the 4 week open-label smoking cessation phase of the study. During Weeks 1-3, subjects will receive 21mg/day, and during Week 4, subjects will receive 14 mg/day. Those subjects who reached continuous abstinence on at least week 4 of the open-label phase will receive 7mg/day during Week 5 while taking GSK598809 or placebo.', 'armGroupLabels': ['GSK598809 Arm', 'Placebo Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily for 12 weeks', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}