Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT00364156
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2006-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clerman@mail.med.upenn.edu', 'phone': '215-746-7141', 'title': 'Dr. Caryn Lerman', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Extended Patch Treatment', 'description': 'Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.', 'otherNumAtRisk': 282, 'otherNumAffected': 4, 'seriousNumAtRisk': 282, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Patch Treatment', 'description': 'Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.', 'otherNumAtRisk': 286, 'otherNumAffected': 0, 'seriousNumAtRisk': 286, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Agressive Thoughts', 'notes': '10/23/2007-During Session 2 of the study participant reported feeling distraught \\& aggressive thoughts towards family members due to certain personal circumstances. Case discussed \\& participant provided with mental health helpline \\& other resources.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure during Blood Draw', 'notes': '4/17/2006: Participant had a 30-40 sec seizure after their blood draw. Participant recovered on their own from the seizure. Participant was monitored \\& their vitals were normal. Participants successfully completed rest of the session feeling normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'notes': '2 Participants had high BP readings \\>200/110 during participating in the study. Both participants were encouraged to received medical help for uncontrolled hypertension, and discontinue nicotine patch treatment and only receive counseling.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'notes': '10/4/2007: Participant disclosed that she had recently had a stroke shortly after her last visit to the center. She sought medical attention immediately and was advised by her physician to discontinue use of the nicotine patch.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biochemically Verified 7-day Point Prevalence Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Patch Treatment', 'description': 'Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.'}, {'id': 'OG001', 'title': 'Standard Patch Treatment', 'description': 'Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (week 24)', 'description': 'To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended Patch Treatment', 'description': 'Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.'}, {'id': 'FG001', 'title': 'Standard Patch Treatment', 'description': 'Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '205'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited using mass media advertising from the the Greater Philadelphia area from June 2004 to April 2008.', 'preAssignmentDetails': 'Once participants were enrolled and were eligible at the medical screening visit they were randomized to receiving either 8 weeks of 21 mg nicotine patch or 6 months of 21 mg nicotine patch treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended Patch Treatment', 'description': 'Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.'}, {'id': 'BG001', 'title': 'Standard Patch Treatment', 'description': 'Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '567', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '44.8', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2006-08-14', 'resultsFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2006-08-14', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-06', 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically Verified 7-day Point Prevalence Abstinence', 'timeFrame': 'End of Treatment (week 24)', 'description': 'To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['TOBACCO USE CESSATION']}, 'referencesModule': {'references': [{'pmid': '18328642', 'type': 'RESULT', 'citation': 'Patterson F, Kerrin K, Wileyto EP, Lerman C. Increase in anger symptoms after smoking cessation predicts relapse. Drug Alcohol Depend. 2008 May 1;95(1-2):173-6. doi: 10.1016/j.drugalcdep.2008.01.013. Epub 2008 Mar 6.'}, {'pmid': '20124230', 'type': 'RESULT', 'citation': 'Schnoll RA, Patterson F, Wileyto EP, Heitjan DF, Shields AE, Asch DA, Lerman C. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Ann Intern Med. 2010 Feb 2;152(3):144-51. doi: 10.7326/0003-4819-152-3-201002020-00005.'}, {'pmid': '19000709', 'type': 'RESULT', 'citation': 'Schnoll RA, Patterson F, Wileyto EP, Tyndale RF, Benowitz N, Lerman C. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study. Pharmacol Biochem Behav. 2009 Mar;92(1):6-11. doi: 10.1016/j.pbb.2008.10.016. Epub 2008 Oct 31.'}, {'pmid': '20336063', 'type': 'RESULT', 'citation': 'Lerman C, Jepson C, Wileyto EP, Patterson F, Schnoll R, Mroziewicz M, Benowitz N, Tyndale RF. Genetic variation in nicotine metabolism predicts the efficacy of extended-duration transdermal nicotine therapy. Clin Pharmacol Ther. 2010 May;87(5):553-7. doi: 10.1038/clpt.2010.3. Epub 2010 Mar 24.'}, {'pmid': '20147892', 'type': 'RESULT', 'citation': 'Ray R, Mitra N, Baldwin D, Guo M, Patterson F, Heitjan DF, Jepson C, Wileyto EP, Wei J, Payne T, Ma JZ, Li MD, Lerman C. Convergent evidence that choline acetyltransferase gene variation is associated with prospective smoking cessation and nicotine dependence. Neuropsychopharmacology. 2010 May;35(6):1374-82. doi: 10.1038/npp.2010.7. Epub 2010 Feb 10.'}, {'pmid': '23669629', 'type': 'DERIVED', 'citation': 'Ashare RL, Wileyto EP, Perkins KA, Schnoll RA. The first 7 days of a quit attempt predicts relapse: validation of a measure for screening medications for nicotine dependence. J Addict Med. 2013 Jul-Aug;7(4):249-54. doi: 10.1097/ADM.0b013e31829363e1.'}]}, 'descriptionModule': {'briefSummary': 'This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.', 'detailedDescription': 'Please see brief summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.\n2. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.\n3. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.\n\nExclusion Criteria:\n\n1. Women who are pregnant, planning a pregnancy, or lactating.\n2. Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes.\n3. Current treatment of cancer or diagnosed with cancer in the past 6 months\n4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).\n5. Current use of TN or other forms of NRT.\n6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).'}, 'identificationModule': {'nctId': 'NCT00364156', 'briefTitle': 'Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation', 'orgStudyIdInfo': {'id': '801851'}, 'secondaryIdInfos': [{'id': 'P50CA084718', 'link': 'https://reporter.nih.gov/quickSearch/P50CA084718', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended Patch Treatment', 'description': 'Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions.', 'interventionNames': ['Drug: 24-weeks of nicotine patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Patch Treatment', 'description': 'Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.', 'interventionNames': ['Drug: Standard Patch Treatment']}], 'interventions': [{'name': 'Standard Patch Treatment', 'type': 'DRUG', 'description': '8-weeks of nicotine patch + 16-weeks of placebo', 'armGroupLabels': ['Standard Patch Treatment']}, {'name': '24-weeks of nicotine patch', 'type': 'DRUG', 'description': '24-weeks of 21mg nicotine patch', 'armGroupLabels': ['Extended Patch Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Tobacco Use Research Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Caryn Lerman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}