Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-09 @ 5:28 AM
Study NCT ID:
NCT03612960
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ahobkirk@pennstatehealth.psu.edu', 'phone': '7175310003', 'title': 'Dr. Andrea Hobkirk', 'phoneExt': '286415', 'organization': 'Pennsylvania State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Exclusion criteria was revised throughout the project (e.g., removed menthol use as exclusion) to accommodate challenges in recruitment.'}}, 'adverseEventsModule': {'timeFrame': '3 years, 4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Very Low Nicotine Content Cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Nicotine Content Cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fractured Finger', 'notes': 'Subject fractured their finger at their work, went to urgent care and was treated there. Was determined to not be related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and Headaches', 'notes': 'Subject had more frequent headaches and nausea after starting a new medication around the same time they began using study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Nicotine Content Cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.\n\nVery low nicotine content cigarettes: Very low nicotine content cigarettes'}, {'id': 'OG001', 'title': 'Normal Nicotine Content Cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.\n\nNormal nicotine content cigarettes: Normal nicotine content cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'The mean percent change in BOLD signal used for this t-test was extracted from a brain cluster with significant group differences in changes in activation over time (voxel p\\<.05, cluster p\\<.05) identified using a whole-brain, voxel-wise two-way mixed effect ANOVA with FSL software.'}], 'paramType': 'MEAN', 'timeFrame': 'Change in BOLD signal from baseline to the 6-week visit.', 'description': 'Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the baseline and post-randomization laboratory visits were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Self-reported Cigarettes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Nicotine Content Cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.'}, {'id': 'OG001', 'title': 'Normal Nicotine Content Cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '16.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.063', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.38', 'ciLowerLimit': '-17.24', 'ciUpperLimit': '0.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.33', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.', 'description': 'Difference in week 6 mean minus week 1 mean of cigarettes used per day reported by participants on daily logs.', 'unitOfMeasure': 'Number of cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Immediate Choices on Monetary Delay Discounting Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Nicotine Content Cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.'}, {'id': 'OG001', 'title': 'Normal Nicotine Content Cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '30.26', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '9.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-21.57', 'ciUpperLimit': '18.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.86', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Changes from baseline to 6-weeks post intervention.', 'description': 'A difference score (6-weeks minus baseline) of the percentage of trials where the immediate (vs. delayed) monetary option was chosen out of all task trials during the monetary delay discounting task that was completed outside of the MRI scan.', 'unitOfMeasure': 'Change in percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both trial laboratory visits were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Very Low Nicotine Content Cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.'}, {'id': 'FG001', 'title': 'Normal Nicotine Content Cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Very Low Nicotine Content Cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.'}, {'id': 'BG001', 'title': 'Normal Nicotine Content Cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.90', 'spread': '7.98', 'groupId': 'BG000'}, {'value': '44.46', 'spread': '8.69', 'groupId': 'BG001'}, {'value': '43.50', 'spread': '8.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cigarettes per day (CPD)', 'classes': [{'categories': [{'measurements': [{'value': '18.90', 'spread': '7.35', 'groupId': 'BG000'}, {'value': '14.46', 'spread': '5.39', 'groupId': 'BG001'}, {'value': '17.21', 'spread': '7.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cigarettes per Day at Baseline', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Menthol vs Non-Menthol', 'classes': [{'categories': [{'title': 'Menthol', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Non-Menthol', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Menthol vs Non-Menthol Cigarettes smoked at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarette Dependence', 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'spread': '1.22', 'groupId': 'BG000'}, {'value': '3.77', 'spread': '1.09', 'groupId': 'BG001'}, {'value': '3.97', 'spread': '1.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Fagerstrom Test for Cigarette Dependence score at baseline. Scores range from 0 to 10, with 10 indicating higher dependence on cigarettes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-20', 'size': 730205, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-05T14:22', 'hasProtocol': True}, {'date': '2021-10-25', 'size': 421620, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-05T14:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2018-07-18', 'resultsFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-29', 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task', 'timeFrame': 'Change in BOLD signal from baseline to the 6-week visit.', 'description': 'Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.'}], 'secondaryOutcomes': [{'measure': 'Change in Self-reported Cigarettes Per Day', 'timeFrame': 'Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.', 'description': 'Difference in week 6 mean minus week 1 mean of cigarettes used per day reported by participants on daily logs.'}, {'measure': 'Change in Percentage of Immediate Choices on Monetary Delay Discounting Task', 'timeFrame': 'Changes from baseline to 6-weeks post intervention.', 'description': 'A difference score (6-weeks minus baseline) of the percentage of trials where the immediate (vs. delayed) monetary option was chosen out of all task trials during the monetary delay discounting task that was completed outside of the MRI scan.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'Nicotine', 'Smoking', 'Functional magnetic resonance imaging', 'Addiction'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.', 'detailedDescription': 'In a double-blind, randomized controlled trial, dependent smokers will be randomized to a 6-week very low nicotine content (VLNC) cigarette condition (N=50) or a 6-week normal nicotine content cigarette control condition (NNC; N=25). Participants will undergo functional magnetic resonance imaging (fMRI) scans at baseline and 6-weeks to investigate the nicotine-related modulation of brain circuitry involved in incentive salience valuation and executive control. Imaging tasks will engage the incentive salience of smoking cues and non-smoking rewards and executive control functions to identify changes in functional activity within, and effective connectivity between, known salience and executive control brain circuitry. A novel fMRI task using specialized odor presentation equipment and fMRI sequences will assess neural cue reactivity to smoke odors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 21-60 years old\n* Smoke \\>5 cigarettes per day\n* \\>1 year of daily smoking\n* No quit attempt in prior month and not planning to quit smoking within next 3 months\n* Able to understand and consent to study procedures\n* High school or lower educational attainment or annual household income \\< $50,000\n* Plan to live in local area next 3 months\n* Women not pregnant or nursing and taking steps to avoid pregnancy\n* Able to read and write in English\n* Access to computer with internet service that allows for Zoom\n\nExclusion Criteria:\n\n* Use of non-cigarette tobacco products in the past 7 days\n* Use of illicit substances more than once a week in the past 3 months (excluding marijuana)\n* Current alcohol abuse impairing participation\n* MRI safety contraindications (e.g., metal implants, claustrophobia)\n* Unstable or significant medical conditions (e.g., chronic obstructive pulmonary disorder, coronary heart disease)\n* Major neurological conditions or brain trauma\n* Major surgeries planned in next 3 months\n* Use of smoking cessation medication in prior month (e.g., varenicline, patch)\n* Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months\n* Unwillingness to provide urine samples\n* Unwilling to smoke study assigned cigarettes for the remainder of the trial\n* Plans to move or take extended travel out of the area in the next 3 months\n* Any other condition or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol\n* Self-reported color blindness\n* Left-handedness\n* Smell dysfunction as determined via standardized assessment"}, 'identificationModule': {'nctId': 'NCT03612960', 'briefTitle': 'Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes', 'orgStudyIdInfo': {'id': '9276'}, 'secondaryIdInfos': [{'id': 'K23DA045081', 'link': 'https://reporter.nih.gov/quickSearch/K23DA045081', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Very low nicotine content cigarettes', 'description': 'Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.', 'interventionNames': ['Drug: Very low nicotine content cigarettes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal nicotine content cigarettes', 'description': 'Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.', 'interventionNames': ['Drug: Normal nicotine content cigarettes']}], 'interventions': [{'name': 'Very low nicotine content cigarettes', 'type': 'DRUG', 'description': 'Very low nicotine content cigarettes', 'armGroupLabels': ['Very low nicotine content cigarettes']}, {'name': 'Normal nicotine content cigarettes', 'type': 'DRUG', 'description': 'Normal nicotine content cigarettes', 'armGroupLabels': ['Normal nicotine content cigarettes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Andrea Hobkirk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrea Hobkirk, PhD', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}