Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-28 @ 9:14 PM
Study NCT ID:
NCT01466361
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2011-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'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': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotine Lozenge 1.5mg (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.', 'otherNumAtRisk': 60, 'otherNumAffected': 1, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine Lozenge 4mg (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.', 'otherNumAtRisk': 52, 'otherNumAffected': 11, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Lozenge 1 (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Lozenge 2 (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.', 'otherNumAtRisk': 41, 'otherNumAffected': 1, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Lozenge 1.5mg (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.'}, {'id': 'OG001', 'title': 'Placebo Lozenge 2 (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.'}], 'classes': [{'title': '1 minute', 'categories': [{'measurements': [{'value': '-15.40', 'spread': '2.439', 'groupId': 'OG000'}, {'value': '-8.17', 'spread': '2.958', 'groupId': 'OG001'}]}]}, {'title': '3 minutes', 'categories': [{'measurements': [{'value': '-24.42', 'spread': '3.108', 'groupId': 'OG000'}, {'value': '-17.26', 'spread': '3.770', 'groupId': 'OG001'}]}]}, {'title': '5 minutes', 'categories': [{'measurements': [{'value': '-30.19', 'spread': '3.257', 'groupId': 'OG000'}, {'value': '-23.86', 'spread': '3.950', 'groupId': 'OG001'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '-35.33', 'spread': '3.428', 'groupId': 'OG000'}, {'value': '-30.23', 'spread': '4.158', 'groupId': 'OG001'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '-38.99', 'spread': '3.689', 'groupId': 'OG000'}, {'value': '-33.99', 'spread': '4.475', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0643', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.23', 'ciLowerLimit': '-14.89', 'ciUpperLimit': '0.44', 'estimateComment': 'Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1489', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.16', 'ciLowerLimit': '-16.93', 'ciUpperLimit': '2.61', 'estimateComment': 'Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.33', 'ciLowerLimit': '-16.56', 'ciUpperLimit': '3.90', 'estimateComment': 'Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3491', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.11', 'ciLowerLimit': '-15.87', 'ciUpperLimit': '5.66', 'estimateComment': 'Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3936', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.00', 'ciLowerLimit': '-16.60', 'ciUpperLimit': '6.59', 'estimateComment': 'Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1, 3, 5, 10 and 15 minutes post-treatment', 'description': 'Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Lozenge 4mg (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.'}, {'id': 'OG001', 'title': 'Placebo Lozenge 1 (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}], 'classes': [{'title': '1 minute', 'categories': [{'measurements': [{'value': '-16.82', 'spread': '2.613', 'groupId': 'OG000'}, {'value': '-13.24', 'spread': '3.232', 'groupId': 'OG001'}]}]}, {'title': '3 minutes', 'categories': [{'measurements': [{'value': '-29.52', 'spread': '3.124', 'groupId': 'OG000'}, {'value': '-19.82', 'spread': '3.865', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3922', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.58', 'ciLowerLimit': '-11.85', 'ciUpperLimit': '4.70', 'estimateComment': 'Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.70', 'ciLowerLimit': '-19.59', 'ciUpperLimit': '0.20', 'estimateComment': 'Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.', 'groupDescription': 'Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 minutes and 15 minutes post-treatment', 'description': 'Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who had at least one cravings assessment measurement post dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Smokers Group', 'description': 'Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment'}, {'id': 'OG001', 'title': 'Heavy Smokers Group', 'description': 'Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm', 'description': 'Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Lozenge 4 mg (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.'}, {'id': 'OG001', 'title': 'Placebo Lozenge 1 (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}, {'id': 'OG002', 'title': 'Nicotine Lozenge 1.5mg (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.'}, {'id': 'OG003', 'title': 'Placebo Lozenge 2 (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 0 minute, 60 minutes and 5 days post treatment', 'description': 'AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.\n\nSAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized participants who received the study treatments were considered evaluable for safety.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.'}, {'id': 'FG001', 'title': 'Placebo Lozenge (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}, {'id': 'FG002', 'title': 'Nicotine Lozenge 1.5mg (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.'}, {'id': 'FG003', 'title': 'Placebo Lozenge (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'Participants who smoked more than 5 cigarettes per day were included in the study. Participants were stratified to treatments according to their smoking status: heavy smokers: smoking greater than 20 cigarettes per day and light smokers: smoking between 6 - 20 cigarettes per day.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Lozenge 4 mg (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.'}, {'id': 'BG001', 'title': 'Placebo Lozenge 1 (Heavy Smokers Group)', 'description': 'Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}, {'id': 'BG002', 'title': 'Nicotine Lozenge 1.5mg (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.'}, {'id': 'BG003', 'title': 'Placebo Lozenge 2 (Light Smokers Group)', 'description': 'Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '10.42', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '9.43', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '11.48', 'groupId': 'BG002'}, {'value': '45.0', 'spread': '10.59', 'groupId': 'BG003'}, {'value': '45.0', 'spread': '10.48', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nicotine cravings assessment baseline scores on a Visual Analogue scale (VAS)', 'classes': [{'title': 'Baseline score prior provoked craving paradigm(B1)', 'categories': [{'measurements': [{'value': '68.3', 'spread': '29.147', 'groupId': 'BG000'}, {'value': '69.54', 'spread': '26.534', 'groupId': 'BG001'}, {'value': '70.00', 'spread': '20.895', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '25.785', 'groupId': 'BG003'}, {'value': '67.5', 'spread': '26.090', 'groupId': 'BG004'}]}]}, {'title': 'Baseline score post provoked craving paradigm (B2)', 'categories': [{'measurements': [{'value': '76.03', 'spread': '24.849', 'groupId': 'BG000'}, {'value': '78.39', 'spread': '23.659', 'groupId': 'BG001'}, {'value': '76.96', 'spread': '21.667', 'groupId': 'BG002'}, {'value': '69.1', 'spread': '26.335', 'groupId': 'BG003'}, {'value': '75.1', 'spread': '24.127', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were prohibited from smoking for 4 hours and then exposed to a provoked craving paradigm. During the provoked craving paradigm subjects were exposed to the sight and smell of a lit cigarette and were forbidden from putting the cigarette in their mouth. Cravings assessment was completed at the start of and immediately following the provoked craving paradigm using a VAS.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2011-11-03', 'resultsFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2011-11-06', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-08', 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers', 'timeFrame': 'Baseline, 1, 3, 5, 10 and 15 minutes post-treatment', 'description': 'Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.'}, {'measure': 'Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers', 'timeFrame': 'Baseline, 3 minutes and 15 minutes post-treatment', 'description': 'Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group', 'timeFrame': 'Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm', 'description': 'Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)', 'timeFrame': 'Baseline, 0 minute, 60 minutes and 5 days post treatment', 'description': 'AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.\n\nSAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nicotine', 'Nicotine craving'], 'conditions': ['Smoking', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '29663982', 'type': 'DERIVED', 'citation': 'Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy smokers who smoke more than 5 cigarettes per day\n* Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)\\^2\n* Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.\n\nExclusion Criteria:\n\n* Women who are pregnant or who have a positive urine pregnancy test.\n* Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.\n* Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.\n* Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.\n* Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.'}, 'identificationModule': {'nctId': 'NCT01466361', 'briefTitle': 'Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving', 'orgStudyIdInfo': {'id': 'S7120994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lower dose Nicotine', 'description': 'lower dose nicotine lozenge', 'interventionNames': ['Drug: Nicotine lower dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Higher dose Nicotine', 'description': 'higher dose Nicotine lozenge', 'interventionNames': ['Drug: Nicotine higher dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nicotine lower dose', 'type': 'DRUG', 'description': 'lower dose nicotine lozenge', 'armGroupLabels': ['Lower dose Nicotine']}, {'name': 'Nicotine higher dose', 'type': 'DRUG', 'description': 'higher dose nicotine lozenge', 'armGroupLabels': ['Higher dose Nicotine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Clinical Trials', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=19926', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}