Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01087905
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2010-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D000074164', 'term': 'Nicotine Chewing Gum'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sss@ctri.medicine.wisc.edu', 'phone': '608-262-7563', 'title': 'Stevens S. Smith, Ph.D.', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Information about adverse events was collected during the 6-week post-quit period of study interventions. The quitline vendor for the study, Free & Clear (Seattle, WA), dispensed all study medications and addressed adverse events.', 'description': 'This study used FDA-approved, over-the-counter nicotine replacement therapies (NRTs) that were dispensed according to standard protocols that were in use by Free \\& Clear at the time of the study. Free \\& Clear was responsible for assessing and managing any AEs related to study medication as per their existing Nicotine Replacement Therapy Protocols.', 'eventGroups': [{'id': 'EG000', 'title': 'Two Weeks of Nicotine Patch Only', 'description': 'Participants in this treatment group received Two Weeks of Nicotine Patch Only.', 'otherNumAtRisk': 245, 'otherNumAffected': 0, 'seriousNumAtRisk': 245, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)', 'description': 'Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.', 'otherNumAtRisk': 245, 'otherNumAffected': 0, 'seriousNumAtRisk': 245, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Six Weeks of Nicotine Patch Only', 'description': 'Participants in this treatment group received Six Weeks of Nicotine Patch Only.', 'otherNumAtRisk': 249, 'otherNumAffected': 0, 'seriousNumAtRisk': 249, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)', 'description': 'Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.', 'otherNumAtRisk': 248, 'otherNumAffected': 0, 'seriousNumAtRisk': 248, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '7-Day Point Prevalence Abstinence From Smoking by Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}, {'value': '493', 'groupId': 'OG003'}, {'value': '485', 'groupId': 'OG004'}, {'value': '502', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Two Weeks of Nicotine Replacement Therapy (NRT)', 'description': 'Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).'}, {'id': 'OG001', 'title': 'Six Weeks of Nicotine Replacement Therapy (NRT)', 'description': 'Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).'}, {'id': 'OG002', 'title': 'NRT Monotherapy (Nicotine Patch Only)', 'description': 'Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).'}, {'id': 'OG003', 'title': 'NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)', 'description': 'Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).'}, {'id': 'OG004', 'title': 'Standard Cessation Counseling (No CMAC)', 'description': 'Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).'}, {'id': 'OG005', 'title': 'Standard Cessation Counseling Plus CMAC)', 'description': 'Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}, {'value': '42.3', 'groupId': 'OG002'}, {'value': '49.9', 'groupId': 'OG003'}, {'value': '47.6', 'groupId': 'OG004'}, {'value': '44.6', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '.076', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.61', 'groupDescription': 'Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.\n\nThe study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.017', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.75', 'groupDescription': 'Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.\n\nThe study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.343', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.14', 'groupDescription': 'Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.\n\nThe study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after the target quit smoking date', 'description': 'Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.', 'unitOfMeasure': 'Percentage of participants not smoking', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.'}, {'type': 'PRIMARY', 'title': '7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Two Weeks of Nicotine Patch Only', 'description': 'Participants in this treatment group received Two Weeks of Nicotine Patch Only.'}, {'id': 'OG001', 'title': 'Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)', 'description': 'Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.'}, {'id': 'OG002', 'title': 'Six Weeks of Nicotine Patch Only', 'description': 'Participants in this treatment group received Six Weeks of Nicotine Patch Only.'}, {'id': 'OG003', 'title': 'Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)', 'description': 'Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000'}, {'value': '48.2', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}, {'value': '51.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.04', 'ciUpperLimit': '2.14', 'estimateComment': 'Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.', 'groupDescription': 'Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.\n\nThe study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.079', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.97', 'estimateComment': 'Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.', 'groupDescription': 'Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.\n\nThe study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '1.20', 'ciUpperLimit': '2.45', 'estimateComment': 'Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.', 'groupDescription': 'Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.\n\nThe study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after the target quit smoking date', 'description': 'Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.', 'unitOfMeasure': 'Percentage of participants not smoking', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.'}, {'type': 'SECONDARY', 'title': 'Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Two Weeks of Nicotine Patch Only', 'description': 'Participants in this treatment group received Two Weeks of Nicotine Patch Only.'}, {'id': 'OG001', 'title': 'Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)', 'description': 'Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.'}, {'id': 'OG002', 'title': 'Six Weeks of Nicotine Patch Only', 'description': 'Participants in this treatment group received Six Weeks of Nicotine Patch Only.'}, {'id': 'OG003', 'title': 'Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)', 'description': 'Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'incremental cost-effectiveness ratio', 'ciPctValue': '95', 'paramValue': '357', 'pValueComment': 'There is no p-value for the incremental cost-effectiveness ratio (ICER).', 'groupDescription': 'In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.', 'statisticalMethod': 'Incremental cost-effectiveness ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Unit of measurement for ICER is U.S. dollars.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Incremental cost-effectiveness ratio', 'ciPctValue': '95', 'paramValue': '712', 'pValueComment': 'There is no p-value for the incremental cost-effectiveness ratio (ICER).', 'groupDescription': 'In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.', 'statisticalMethod': 'Incremental cost-effectiveness ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Unit of measurement for ICER is U.S. dollars.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Incremental cost-effectiveness ratio', 'ciPctValue': '95', 'paramValue': '1290', 'pValueComment': 'There is no p-value for the incremental cost-effectiveness ratio (ICER).', 'groupDescription': 'In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.', 'statisticalMethod': 'Incremental cost-effectiveness ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Unit of measurement for ICER is U.S. dollars.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after the target quit smoking date', 'description': 'For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.', 'unitOfMeasure': 'U.S. Dollars', 'reportingStatus': 'POSTED', 'populationDescription': 'No "a priori" power analysis was conducted for this secondary outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 Weeks of Nicotine Patch Only, No CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG001', 'title': '2 Weeks of Nicotine Patch Only Plus CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG002', 'title': '2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG003', 'title': '2 Weeks of Nicotine Patch+Nicotine Gum and CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG004', 'title': '6 Weeks of Nicotine Patch Only, No CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG005', 'title': '6 Weeks of Nicotine Patch Only Plus CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG006', 'title': '6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'FG007', 'title': '6 Weeks of Nicotine Patch+Nicotine Gum and CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '123'}, {'groupId': 'FG003', 'numSubjects': '122'}, {'groupId': 'FG004', 'numSubjects': '122'}, {'groupId': 'FG005', 'numSubjects': '127'}, {'groupId': 'FG006', 'numSubjects': '121'}, {'groupId': 'FG007', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '101'}, {'groupId': 'FG003', 'numSubjects': '86'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '99'}, {'groupId': 'FG006', 'numSubjects': '98'}, {'groupId': 'FG007', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '28'}, {'groupId': 'FG006', 'numSubjects': '23'}, {'groupId': 'FG007', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '20'}, {'groupId': 'FG007', 'numSubjects': '24'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Adult smokers who called the Wisconsin Tobacco Quit Line (WTQL) from April 1, 2010 to June 15, 2010 were invited to participate in the study; no advertising or targeted recruitment was utilized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}, {'value': '121', 'groupId': 'BG006'}, {'value': '127', 'groupId': 'BG007'}, {'value': '987', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '2 Weeks of Nicotine Patch Only, No CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG001', 'title': '2 Weeks of Nicotine Patch Only Plus CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG002', 'title': '2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG003', 'title': '2 Weeks of Nicotine Patch+Nicotine Gum and CMAC', 'description': 'Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG004', 'title': '6 Weeks of Nicotine Patch Only, No CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG005', 'title': '6 Weeks of Nicotine Patch Only Plus CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG006', 'title': '6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG007', 'title': '6 Weeks of Nicotine Patch+Nicotine Gum and CMAC', 'description': 'Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).'}, {'id': 'BG008', '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': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '119', 'groupId': 'BG005'}, {'value': '114', 'groupId': 'BG006'}, {'value': '123', 'groupId': 'BG007'}, {'value': '946', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.33', 'spread': '12.99', 'groupId': 'BG000'}, {'value': '43.35', 'spread': '12.61', 'groupId': 'BG001'}, {'value': '41.39', 'spread': '11.24', 'groupId': 'BG002'}, {'value': '40.84', 'spread': '11.96', 'groupId': 'BG003'}, {'value': '41.74', 'spread': '14.19', 'groupId': 'BG004'}, {'value': '43.18', 'spread': '13.627', 'groupId': 'BG005'}, {'value': '42.61', 'spread': '13.51', 'groupId': 'BG006'}, {'value': '40.03', 'spread': '13.31', 'groupId': 'BG007'}, {'value': '41.93', 'spread': '12.96', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}, {'value': '74', 'groupId': 'BG006'}, {'value': '79', 'groupId': 'BG007'}, {'value': '569', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '418', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}, {'value': '121', 'groupId': 'BG006'}, {'value': '127', 'groupId': 'BG007'}, {'value': '987', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline sample=987 adult smokers (at least 18 years of age) who called the Wisconsin Tobacco Quit Line (WTQL) from April 1, 2010 to June 15, 2010.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 987}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2010-03-15', 'resultsFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-22', 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-Day Point Prevalence Abstinence From Smoking by Intervention', 'timeFrame': '26 weeks after the target quit smoking date', 'description': 'Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.'}, {'measure': '7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group', 'timeFrame': '26 weeks after the target quit smoking date', 'description': 'Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.'}], 'secondaryOutcomes': [{'measure': 'Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group', 'timeFrame': '26 weeks after the target quit smoking date', 'description': 'For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'Smoking cessation', 'Medication adherence'], 'conditions': ['Smoking', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '22992296', 'type': 'RESULT', 'citation': 'Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.'}], 'seeAlsoLinks': [{'url': 'http://www.ctri.wisc.edu/', 'label': 'University of Wisconsin Center for Tobacco Research and Intervention'}]}, 'descriptionModule': {'briefSummary': 'Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.', 'detailedDescription': 'The study design is a fully crossed 2x2x2 factorial design that tested the effect of two versus six weeks of nicotine replacement therapy (NRT), the effect of NRT monotherapy (nicotine patch alone) versus NRT combination therapy (nicotine patch + oral NRT), and the effect of cognitive medication adherence counseling (CMAC) versus no CMAC. A total of 987 smokers seeking cessation assistance from the Wisconsin Tobacco Quit Line (WTQL) were randomly assigned to the eight (2x2x2) different conditions generated by the three experimental factors. This design provides us with sufficient power to analyze each of our three main effects listed above. We will also test for two- and three-way interactions, but do not have sufficient data to make a priori assumptions about interaction effects. Finally, we will conduct a cost-effectiveness analysis for each of the three interventions to allow readers of this research to evaluate whether the additional costs of the interventions yield sufficient gains to warrant implementing them broadly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The only people eligible for this study are Wisconsin residents who contact the Wisconsin Tobacco Quit Line for smoking cessation services.\n\nInclusion Criteria:\n\n* Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free \\& Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.\n\nExclusion Criteria:\n\n* Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.'}, 'identificationModule': {'nctId': 'NCT01087905', 'briefTitle': 'Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines', 'orgStudyIdInfo': {'id': 'H2009-0074'}, 'secondaryIdInfos': [{'id': '1RC1CA144382-01', 'link': 'https://reporter.nih.gov/quickSearch/1RC1CA144382-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2 Weeks of Nicotine Patch Only, No CMAC', 'description': 'Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling)\n\n2 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks', 'interventionNames': ['Drug: Nicotine patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Weeks of Nicotine Patch Only plus CMAC', 'description': 'Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling\n\n2 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks', 'interventionNames': ['Drug: Nicotine patch', 'Behavioral: CMAC']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Wks Nicotine Patch+Nic Gum, No CMAC', 'description': 'Participants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling)\n\n2 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks\n\n2 Weeks of Nicotine gum dosed as follows:\n\nIf \\< 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.\n\nIf ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.', 'interventionNames': ['Drug: Nicotine patch', 'Drug: Nicotine gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Wks Nicotine Patch+Nic Gum plus CMAC', 'description': 'Participants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling\n\n2 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks\n\n2 Weeks of Nicotine gum dosed as follows:\n\nIf \\< 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.\n\nIf ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.', 'interventionNames': ['Drug: Nicotine patch', 'Drug: Nicotine gum', 'Behavioral: CMAC']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 Weeks of Nicotine Patch Only, No CMAC', 'description': 'Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling)\n\n6 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks', 'interventionNames': ['Drug: Nicotine patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 Weeks of Nicotine Patch Only plus CMAC', 'description': 'Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling\n\n6 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks', 'interventionNames': ['Drug: Nicotine patch', 'Behavioral: CMAC']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 Wks Nicotine Patch+Nic Gum, No CMAC', 'description': 'Participants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling)\n\n6 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks\n\n6 Weeks of Nicotine gum dosed as follows:\n\nIf \\< 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.\n\nIf ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.', 'interventionNames': ['Drug: Nicotine patch', 'Drug: Nicotine gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 Wks Nicotine Patch+Nic Gum plus CMAC', 'description': 'Participants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling\n\n6 Weeks of Nicotine patch dosed as follows:\n\nIf \\> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks\n\n6 Weeks of Nicotine gum dosed as follows:\n\nIf \\< 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.\n\nIf ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.', 'interventionNames': ['Drug: Nicotine patch', 'Drug: Nicotine gum', 'Behavioral: CMAC']}], 'interventions': [{'name': 'Nicotine patch', 'type': 'DRUG', 'description': 'If \\> 10 cigs/day: one 21 mg nicotine patch per day\n\nIf \\< or = 10 cigs/day: one 14 mg nicotine patch per day', 'armGroupLabels': ['2 Weeks of Nicotine Patch Only plus CMAC', '2 Weeks of Nicotine Patch Only, No CMAC', '2 Wks Nicotine Patch+Nic Gum plus CMAC', '2 Wks Nicotine Patch+Nic Gum, No CMAC', '6 Weeks of Nicotine Patch Only plus CMAC', '6 Weeks of Nicotine Patch Only, No CMAC', '6 Wks Nicotine Patch+Nic Gum plus CMAC', '6 Wks Nicotine Patch+Nic Gum, No CMAC']}, {'name': 'Nicotine gum', 'type': 'DRUG', 'otherNames': ['Nicotine polacrilex'], 'description': 'If \\< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.\n\nIf ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.', 'armGroupLabels': ['2 Wks Nicotine Patch+Nic Gum plus CMAC', '2 Wks Nicotine Patch+Nic Gum, No CMAC', '6 Wks Nicotine Patch+Nic Gum plus CMAC', '6 Wks Nicotine Patch+Nic Gum, No CMAC']}, {'name': 'CMAC', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Medication Adherence Counseling'], 'description': 'CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.', 'armGroupLabels': ['2 Weeks of Nicotine Patch Only plus CMAC', '2 Wks Nicotine Patch+Nic Gum plus CMAC', '6 Weeks of Nicotine Patch Only plus CMAC', '6 Wks Nicotine Patch+Nic Gum plus CMAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53711', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Center for Tobacco Research and Intervention', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Stevens S Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health'}, {'name': 'Paula A Keller, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Upon request, clinical trial data will be shared with other investigators in the form of de-identified datasets. Requests can be sent to Stevens S. Smith, Ph.D., at sss@ctri.wisc.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wisconsin Department of Health and Family Services', 'class': 'OTHER_GOV'}, {'name': 'Consumer Wellness Solutions', 'class': 'INDUSTRY'}, {'name': 'Department of Health and Human Services', 'class': 'FED'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}