Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-06 @ 7:25 AM
Study NCT ID:
NCT01476202
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2011-11-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Provoked Craving Relief Study by NRT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': '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': 'AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotine Mouth Strip 2.5 mg', 'description': 'Participants self administered single dose of 2.5 mg nicotine mouth strip.', 'otherNumAtRisk': 40, 'otherNumAffected': 1, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants self administered single dose of 2 mg nicotine lozenge.', 'otherNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nicotine Gum 2 mg', 'description': 'Participants self administered single dose of 2 mg nicotine gum.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Nicotine Craving Score on a VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Mouth Strip 2.5 mg', 'description': 'Participants self administered a single dose of 2.5 mg nicotine mouth strip.'}, {'id': 'OG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants self administered a single dose of 2 mg nicotine lozenge.'}, {'id': 'OG002', 'title': 'Nicotine Gum 2 mg', 'description': 'Participants self administered a single dose of 2 mg nicotine gum.'}], 'classes': [{'title': '50 seconds', 'categories': [{'measurements': [{'value': '-11.3', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': '3 minutes', 'categories': [{'measurements': [{'value': '-28.2', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '-17.6', 'spread': '18.4', 'groupId': 'OG002'}]}]}, {'title': '5 minutes', 'categories': [{'measurements': [{'value': '-35.8', 'spread': '31.0', 'groupId': 'OG000'}, {'value': '-18.3', 'spread': '22.8', 'groupId': 'OG001'}, {'value': '-27.2', 'spread': '24.0', 'groupId': 'OG002'}]}]}, {'title': '7 minutes', 'categories': [{'measurements': [{'value': '-39.0', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '-25.5', 'spread': '27.2', 'groupId': 'OG001'}, {'value': '-33.8', 'spread': '27.5', 'groupId': 'OG002'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '-43.9', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '-38.4', 'spread': '29.9', 'groupId': 'OG002'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '-45.2', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '-34.4', 'spread': '29.1', 'groupId': 'OG001'}, {'value': '-40.2', 'spread': '30.7', 'groupId': 'OG002'}]}]}, {'title': '20 minutes', 'categories': [{'measurements': [{'value': '-47.9', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '-37.4', 'spread': '30.1', 'groupId': 'OG001'}, {'value': '-42.7', 'spread': '31.6', 'groupId': 'OG002'}]}]}, {'title': '25 minutes', 'categories': [{'measurements': [{'value': '-47.3', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '-40.7', 'spread': '30.9', 'groupId': 'OG001'}, {'value': '-43.5', 'spread': '29.7', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '-45.2', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '-42.8', 'spread': '32.1', 'groupId': 'OG001'}, {'value': '-42.3', 'spread': '31.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration', '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 was measured.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.'}, {'type': 'SECONDARY', 'title': 'Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Mouth Strip 2.5 Milligram (mg)', 'description': 'Participants self administered single dose of 2.5 mg nicotine mouth strip.'}, {'id': 'OG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants self administered single dose of 2 mg nicotine lozenge.'}, {'id': 'OG002', 'title': 'Nicotine Gum 2 mg', 'description': 'Participants self administered single dose of 2 mg nicotine gum.'}], 'classes': [{'title': 'AUC (0-50 seconds)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.99', 'upperLimit': '4.05'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '4.05', 'upperLimit': '4.12'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '4.03', 'upperLimit': '4.10'}]}]}, {'title': 'AUC (0-3 minutes)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '5.06', 'upperLimit': '5.20'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '5.23', 'upperLimit': '5.38'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '5.17', 'upperLimit': '5.32'}]}]}, {'title': 'AUC (0-5 minutes)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.42', 'upperLimit': '5.61'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '5.65', 'upperLimit': '5.84'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '5.57', 'upperLimit': '5.76'}]}]}, {'title': 'AUC (0-7 minutes)', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.64', 'upperLimit': '5.87'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.89', 'upperLimit': '6.12'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '5.81', 'upperLimit': '6.03'}]}]}, {'title': 'AUC (0-10 minutes)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5.88', 'upperLimit': '6.14'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '6.14', 'upperLimit': '6.41'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '6.05', 'upperLimit': '6.31'}]}]}, {'title': 'AUC (0-15 minutes)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '6.15', 'upperLimit': '6.45'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '6.42', 'upperLimit': '6.73'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '6.32', 'upperLimit': '6.62'}]}]}, {'title': 'AUC (0-20 minutes)', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '6.35', 'upperLimit': '6.68'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '6.62', 'upperLimit': '6.95'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '6.50', 'upperLimit': '6.83'}]}]}, {'title': 'AUC (0-25 minutes)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '6.51', 'upperLimit': '6.87'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '6.76', 'upperLimit': '7.12'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '6.64', 'upperLimit': '7.00'}]}]}, {'title': 'AUC (0-30 minutes)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '6.65', 'upperLimit': '7.03'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '6.87', 'upperLimit': '7.25'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '6.76', 'upperLimit': '7.14'}]}]}], 'paramType': 'LOG_MEAN', 'timeFrame': 'Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration', 'description': 'AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.', 'unitOfMeasure': 'Score on a scale*minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Mouth Strip 2.5 Milligram (mg)', 'description': 'Participants self administered a single dose of 2.5 mg nicotine mouth strip.'}, {'id': 'FG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants self administered a single dose of 2 mg nicotine lozenge.'}, {'id': 'FG002', 'title': 'Nicotine Gum 2 mg', 'description': 'Participants self administered a single dose of 2 mg nicotine gum.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'Of 140 screened participants, 120 were randomized while 17 participants were screen failures, and 3 participants were not randomized due to other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Mouth Strip 2.5 mg', 'description': 'Participants self administered a single dose of 2.5 mg nicotine mouth strip.'}, {'id': 'BG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants self administered a single dose of 2 mg nicotine lozenge.'}, {'id': 'BG002', 'title': 'Nicotine Gum 2 mg', 'description': 'Participants self administered a single dose of 2 mg nicotine lozenge.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '37.4', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '35.0', 'spread': '11.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2011-11-17', 'resultsFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2011-11-17', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-30', 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Nicotine Craving Score on a VAS', 'timeFrame': 'Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration', '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 was measured.'}], 'secondaryOutcomes': [{'measure': 'Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)', 'timeFrame': 'Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration', 'description': 'AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Smoking Status: Current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up.\n\nExclusion Criteria:\n\n* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.\n* Prior Concomitant Medication: a. Treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit. b. Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit. c. Use of any over-the-counter (OTC) medication that affects central nervous system such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit. d. Use of any nicotine replacement therapy or any other treatment for smoking cessation (e.g. bupropion or varenicline) within one month of screening visit. e. Use of any nicotine containing products at any time during the Provocation/Treatment visit. f. Use of any medications noted in the exclusion criteria, or use of any product that would, in the opinion of the investigator, jeopardize the safety of the subject or impact on the validity of the study results.\n* Any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. A medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia.\n* Expired Carbon Monoxide (CO): Any subject whose CO level rises during the sequestration period (i.e., the subject's expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.\n* Alcohol: Consumption of any alcoholic beverage within 24 hours of the craving provocation visit, as indicated by a positive breath alcohol test."}, 'identificationModule': {'nctId': 'NCT01476202', 'acronym': 'NRT', 'briefTitle': 'Provoked Craving Relief Study by NRT', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Pilot Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Strip, Nicorette ® Nicotine Lozenge and Gum', 'orgStudyIdInfo': {'id': 'S2111378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine mouth strip', 'description': 'single dose', 'interventionNames': ['Drug: nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nicotine lozenge', 'description': 'single dose', 'interventionNames': ['Drug: nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nicotine gum', 'description': 'single dose', 'interventionNames': ['Drug: nicotine']}], 'interventions': [{'name': 'nicotine', 'type': 'DRUG', 'description': 'nicotine in the form of a mouth strip, lozenge and gum', 'armGroupLabels': ['Nicotine mouth strip', 'nicotine gum', 'nicotine lozenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Research Associates, Inc.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}