Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT00534404
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2007-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Trial of Internet Access to Nicotine Patches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lcan@med.umich.edu', 'phone': '734-763-6099', 'title': 'Larry An, MD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over a 3-year period, from March 2011-March 2014', 'eventGroups': [{'id': 'EG000', 'title': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\nTelephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.', 'otherNumAtRisk': 827, 'otherNumAffected': 0, 'seriousNumAtRisk': 827, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.', 'otherNumAtRisk': 830, 'otherNumAffected': 0, 'seriousNumAtRisk': 830, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.', 'otherNumAtRisk': 828, 'otherNumAffected': 0, 'seriousNumAtRisk': 828, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Death', 'notes': "Reports of participants' deaths were received third person after the fact. These adverse events were classified by the Institutional Review Board as unrelated to study, unexpected.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 830, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 828, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 830, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 828, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 830, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 828, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported 6-month Prolonged Abstinence From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}, {'value': '586', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\nTelephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'OG001', 'title': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'OG002', 'title': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}], 'classes': [{'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at 9 Months post-randomization', 'description': 'Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Self-reported 30-day Prolonged Abstinence at 9-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}, {'value': '586', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\nTelephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'OG001', 'title': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'OG002', 'title': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}], 'classes': [{'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months post randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported 30-day Prolonged Abstinence at 3-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '593', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\nTelephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'OG001', 'title': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'OG002', 'title': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}], 'classes': [{'categories': [{'measurements': [{'value': '379', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-months post randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\nTelephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'FG001', 'title': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'FG002', 'title': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '827'}, {'groupId': 'FG001', 'numSubjects': '830'}, {'groupId': 'FG002', 'numSubjects': '828'}]}, {'type': 'Completed at Least 1 Online Session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '781'}, {'groupId': 'FG001', 'numSubjects': '813'}, {'groupId': 'FG002', 'numSubjects': '658'}]}, {'type': 'Completed First NRT Order', 'achievements': [{'groupId': 'FG000', 'numSubjects': '765'}, {'comment': 'Participants could order NRT without completing a web session', 'groupId': 'FG001', 'numSubjects': '821'}, {'comment': 'NRT was not available for this arm', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed Second NRT Order', 'achievements': [{'groupId': 'FG000', 'numSubjects': '640'}, {'groupId': 'FG001', 'numSubjects': '789'}, {'comment': 'NRT not available for this arm.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed at Least 1 Counseling Call', 'achievements': [{'groupId': 'FG000', 'numSubjects': '813'}, {'comment': 'There was no counseling offered in this arm', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'There was no counseling offered in this arm', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '1-month Follow up Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '742'}, {'groupId': 'FG001', 'numSubjects': '781'}, {'groupId': 'FG002', 'numSubjects': '626'}]}, {'type': '3-month Follow up Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '682'}, {'groupId': 'FG001', 'numSubjects': '731'}, {'groupId': 'FG002', 'numSubjects': '593'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '647'}, {'groupId': 'FG001', 'numSubjects': '687'}, {'groupId': 'FG002', 'numSubjects': '586'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '242'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'Removed by study staff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '201'}]}]}], 'preAssignmentDetails': 'Interested individuals completed a screening survey to determine eligibility. Following study consent, participants completed two emailed surveys over the next two days and a phone confirmation call before being randomized. These check-ins confirmed the participant had valid contact information and maintained their desire to quit smoking.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '830', 'groupId': 'BG001'}, {'value': '828', 'groupId': 'BG002'}, {'value': '2485', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\nTelephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'BG001', 'title': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.\n\nNicotine patches: Participants will wear nicotine patches.\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'BG002', 'title': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).\n\niQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '796', 'groupId': 'BG000'}, {'value': '791', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}, {'value': '2387', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.27', 'spread': '12.03', 'groupId': 'BG000'}, {'value': '44.31', 'spread': '12.00', 'groupId': 'BG001'}, {'value': '44.20', 'spread': '11.64', 'groupId': 'BG002'}, {'value': '44.26', 'spread': '11.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '562', 'groupId': 'BG000'}, {'value': '581', 'groupId': 'BG001'}, {'value': '578', 'groupId': 'BG002'}, {'value': '1721', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '764', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '797', 'groupId': 'BG000'}, {'value': '797', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}, {'value': '2389', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '714', 'groupId': 'BG000'}, {'value': '725', 'groupId': 'BG001'}, {'value': '712', 'groupId': 'BG002'}, {'value': '2151', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '827', 'groupId': 'BG000'}, {'value': '830', 'groupId': 'BG001'}, {'value': '828', 'groupId': 'BG002'}, {'value': '2485', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Highest education level', 'classes': [{'title': 'High school or less', 'categories': [{'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '643', 'groupId': 'BG003'}]}]}, {'title': 'Some college', 'categories': [{'measurements': [{'value': '440', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}, {'value': '1384', 'groupId': 'BG003'}]}]}, {'title': 'College graduate', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '458', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-21', 'studyFirstSubmitDate': '2007-09-21', 'resultsFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2007-09-21', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-21', 'studyFirstPostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported 6-month Prolonged Abstinence From Smoking', 'timeFrame': 'Measured at 9 Months post-randomization', 'description': 'Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.'}], 'secondaryOutcomes': [{'measure': 'Self-reported 30-day Prolonged Abstinence at 9-month Follow up', 'timeFrame': '9 months post randomization'}, {'measure': 'Self-reported 30-day Prolonged Abstinence at 3-month Follow up', 'timeFrame': '3-months post randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Internet-Assisted Tobacco Treatments', 'Online Smoking Cessation Programs', 'Nicotine Patches', 'Telephone Counseling', 'Smoking Abstinence'], 'conditions': ['Smoking Cessation', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette smokers.', 'detailedDescription': 'The objective of this project is to determine the efficacy and cost-effectiveness of providing access to free nicotine patches, with or without a required linkage to proactive telephone counseling, as adjuncts to internet-assisted tobacco treatment. Online cessation services will be provided by the Center for Health Communication Research at the University of Michigan.\n\nThis investigation has three specific aims and one exploratory aim:\n\n* Specific Aim 1: To determine the efficacy of providing access to free nicotine patches as an addition to online smoking cessation services.\n* Specific Aim 2: To determine the efficacy of providing access to free nicotine patches linked with proactive telephone counseling as an addition to online smoking cessation services.\n* Specific Aim 3: To determine the cost-effectiveness of providing access to free nicotine patches, with or without linkage to proactive phone counseling, as additions to online cessation services.\n* Exploratory Aim 1: To examine potential mediators and moderators of intervention effects. An examination of potential mediators will identify key psychological and behavioral processes (e.g. medication adherence, self-efficacy, etc.) that underlie how the interventions affect the process of quitting and offer guidance regarding key targets for future research. An examination of potential moderators (e.g. level of dependence, income, gender) will identify candidate subgroups for which the proposed interventions may be more effective and cost- effective.\n\nSmokers searching online for help quitting (N=2,475) will be recruited and randomized to receive one of three treatments:\n\n1. online smoking cessation services (i.e. web),\n2. online cessation services plus access to free nicotine patches (i.e.web+patch),\n3. online cessation services with access to free patches contingent upon participation in proactive telephone counseling (i.e. web+patch+phone).\n\nThe Center for Health Communications Research at the University of Michigan will serve as the smoking cessation website for this research project. Developed by Vic Strecher and colleagues, Project Quit is a web-based program designed to help individuals who would like to quit smoking in the next 30 days. The program is grounded in cognitive-behavioral methods of smoking cessation and relapse prevention. The web-based smoking cessation intervention features highly tailored email messages. Once enrolled in the project and the baseline assessment is completed, participants receive six tailored web sessions namely:\n\n* Action plan (1 week before quit date);\n* Barriers 1 (2 days before quit date);\n* Supportive message (on quit date);\n* Barriers 2 (2 days after quit date);\n* Motivation (1 week after quit date);\n* Testimonial (2 weeks after quit date).\n\nEvaluations will occur at baseline and at 1-, 3-, and 9-months post-enrollment. The primary outcome measure will be self-reported 6-month prolonged abstinence measured at the 9-month evaluation.\n\nThis proposal addresses a critical need for evidence-based cessation treatments for smokers. At the completion of this project, it is our expectation that we will have identified an effective online intervention package (or packages) for dissemination of internet-assisted tobacco treatment.\n\nThis study will enroll people recruited via online sources. Participants will complete a baseline survey about their smoking habits and quit history. Participants will then be randomly assigned to one of the following three treatment groups:\n\n* Group 1 participants will receive access to an online tailored stop smoking program.\n* Group 2 participants will receive free access to nicotine patches and an online tailored stop smoking program.\n* Group 3 participants will receive telephone counseling, free access to nicotine patches and an online tailored stop smoking program.\n\nParticipants receiving telephone counseling will receive 5 phone calls over a 2-month period to discuss their personal smoking cessation plan; they must complete the pre-quit and 7-10 day calls in order to receive the nicotine patches. At 1, 3, and 9 months post-enrollment, all participants will complete online surveys about their smoking cessation experience. Participants will be contacted by phone to complete the surveys if they do not complete them online.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently smokes 10 or more cigarettes per day\n* Does not use any tobacco products other than cigarettes\n* Willing to set a quit date within 2 to 4 weeks following study entry\n* Willing to use a nicotine patch\n* Able to speak English\n* Access to Internet, email, and telephone at work or home\n* Resident of the United States\n* Only one person per household is eligible to enroll\n\nExclusion Criteria:\n\n* Medically unable to use the nicotine patch (e.g., pregnant, history of a heart attack)\n* Currently uses nicotine replacement therapy (NRT) products\n* Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban'}, 'identificationModule': {'nctId': 'NCT00534404', 'acronym': 'iQS', 'briefTitle': 'A Randomized Trial of Internet Access to Nicotine Patches', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'iQuit Smoking: A Randomized Trial of Internet Access to Nicotine Patches', 'orgStudyIdInfo': {'id': '511'}, 'secondaryIdInfos': [{'id': 'R01HL086684-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HL086684-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NRT Patch, Phone Counseling, Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.', 'interventionNames': ['Drug: Nicotine patches', 'Behavioral: Telephone counseling', 'Behavioral: iQuit Smoking website']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Patches and Internet', 'description': 'As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.', 'interventionNames': ['Drug: Nicotine patches', 'Behavioral: iQuit Smoking website']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Internet', 'description': 'Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).', 'interventionNames': ['Behavioral: iQuit Smoking website']}], 'interventions': [{'name': 'Nicotine patches', 'type': 'DRUG', 'otherNames': ['Nicoderm CQ'], 'description': 'Participants will wear nicotine patches.', 'armGroupLabels': ['NRT Patch, Phone Counseling, Internet', 'Nicotine Patches and Internet']}, {'name': 'Telephone counseling', 'type': 'BEHAVIORAL', 'description': 'Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.', 'armGroupLabels': ['NRT Patch, Phone Counseling, Internet']}, {'name': 'iQuit Smoking website', 'type': 'BEHAVIORAL', 'description': 'Participants will access the Project Quit (iQuit Smoking) website.', 'armGroupLabels': ['Internet', 'NRT Patch, Phone Counseling, Internet', 'Nicotine Patches and Internet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Lawrence C An, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine, Medical School', 'investigatorFullName': 'Lawrence C. An', 'investigatorAffiliation': 'University of Michigan'}}}}