Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
Study NCT ID:
NCT01588561
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2012-04-06
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nicotine Related Brain Activity: The Influence of Smoking History and Blood Nicotine Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': {'email': 'slukas@mclean.harvard.edu', 'phone': '617-855-2767', 'title': 'Scott Lukas, Ph.D.', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small number of subjects completed due to a large shortage of Nicotine Bitartrate (the chemical used to create our IV Nicotine). We were unable to receive new nicotine shipments from 4/14 -2/15.Without this nicotine it was impossible to run subjects.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Nicotine', 'description': 'Nicotine infusion', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'Saline infusion', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient tightness in chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Nicotine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine', 'description': 'Intravenous Nicotine (1.5 mg/70 kg)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '8', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion', 'description': 'Peak nicotine level in each participant', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Peak nicotine levels were only measured during the nicotine study intervention. One participant had incomplete serum nicotine results and was not included.'}, {'type': 'PRIMARY', 'title': 'Number of Brain Regions With a Change in Brain Activity Relative to Saline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine', 'description': 'Intravenous Nicotine (1.5 mg/70 kg)'}], 'classes': [{'title': 'Increased BOLD Signal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Decreased BOLD Signal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum'}], 'paramType': 'NUMBER', 'timeFrame': '40 minutes after infusion', 'description': 'PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course.\n\nThe main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.', 'unitOfMeasure': 'brain regions', 'reportingStatus': 'POSTED', 'populationDescription': 'The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.'}, {'type': 'SECONDARY', 'title': 'Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine', 'description': 'Intravenous Nicotine (1.5 mg/70 kg)'}], 'classes': [{'title': 'Increased BOLD Signal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Decreased BOLD Signal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum'}], 'paramType': 'NUMBER', 'timeFrame': '40 minutes after infusion', 'description': 'PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years).\n\nThe main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.', 'unitOfMeasure': 'brain regions', 'reportingStatus': 'POSTED', 'populationDescription': 'The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.'}, {'type': 'SECONDARY', 'title': 'Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine', 'description': 'Intravenous Nicotine (1.5 mg/70 kg)'}], 'classes': [{'title': 'Increased BOLD Signal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Decreased BOLD Signal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal\\&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum'}], 'paramType': 'NUMBER', 'timeFrame': '40 minutes after infusion', 'description': 'PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.', 'unitOfMeasure': 'brain regions', 'reportingStatus': 'POSTED', 'populationDescription': 'The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.'}, {'type': 'SECONDARY', 'title': 'Final Nicotine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine', 'description': 'Intravenous Nicotine (1.5 mg/70 kg)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes post-infusion', 'description': 'Final nicotine level in each participant', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant had incomplete serum nicotine results and was not included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First, Then Nicotine', 'description': 'Placebo first, then Intravenous Nicotine (1.5 mg/70 kg)'}, {'id': 'FG001', 'title': 'Nicotine First, Then Placebo', 'description': 'Intravenous Nicotine (1.5 mg/70 kg) first, then Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'First Injection (Visit 1)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Rest Period', 'comment': 'Generally 2-3 week rest period but a minimum of 1 month for women, based on menstrual cycles.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Second Injection (Visit 2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All study participants. All participants were randomized to receive all interventions, so all participants are combined into one Arm/Group.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pack-years', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'calculated by reported daily cigarettes smoked divided by 20/pack and multiplied by the number of years reported smoking', 'unitOfMeasure': 'pack-years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fagerström score', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '1.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Fagerstrom test for nicotine dependence:\n\nhttp://ndri.curtin.edu.au/btitp/documents/Fagerstrom\\_test.pdf Scores ranged between 1 to 10, 1-2 = low dependence, 3-4 = low to moderate dependence, 5-7 = moderate dependence, 8+ = high dependence', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2012-04-06', 'resultsFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-31', 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Nicotine Levels', 'timeFrame': '0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion', 'description': 'Peak nicotine level in each participant'}, {'measure': 'Number of Brain Regions With a Change in Brain Activity Relative to Saline', 'timeFrame': '40 minutes after infusion', 'description': 'PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course.\n\nThe main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.'}], 'secondaryOutcomes': [{'measure': 'Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History', 'timeFrame': '40 minutes after infusion', 'description': 'PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years).\n\nThe main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.'}, {'measure': 'Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine', 'timeFrame': '40 minutes after infusion', 'description': 'PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.'}, {'measure': 'Final Nicotine Levels', 'timeFrame': '30 minutes post-infusion', 'description': 'Final nicotine level in each participant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '23117126', 'type': 'RESULT', 'citation': 'Yamamoto RT, Rohan ML, Goletiani N, Olson D, Peltier M, Renshaw PF, Mello NK. Nicotine related brain activity: the influence of smoking history and blood nicotine levels, an exploratory study. Drug Alcohol Depend. 2013 Apr 1;129(1-2):137-44. doi: 10.1016/j.drugalcdep.2012.10.002. Epub 2012 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we sought to explore brain activity in nicotine-dependent men in response to acute intravenous nicotine using pharmacological magnetic resonance imaging (phMRI).', 'detailedDescription': "phMRI was used to evaluate brain activity in response to 1.5 mg/70 kg intravenous nicotine or saline. The nicotine and saline were administered on different visits. The time courses of individual subjects' nicotine levels were used as regressors to assess neural activity relating to the infusions. The influence of Smoking history and physiological measures on the response to nicotine were also investigated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between the ages of 18 and 40 who currently smoke at least 15 cigarettes every day, and who fulfill DSM-IV diagnostic criteria for nicotine dependence will be eligible for participation.\n* No evidence of clinically significant disease based upon complete medical history and physical examination by a qualified physician.\n* Absence of DSM-IV Axis I Disorders other than nicotine dependence (305.10) as measured by the Structured Clinical Interview (SCID).\n* Routine laboratory blood tests including complete blood count, electrolytes, BUN and creatinine, liver function tests, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but subjects who have hepatitis serology consistent with previous exposure to Hepatitis A, Hepatitis B, or Hepatitis C, but who do not have clinical and biochemical evidence of acute infection, will be acceptable.\n* Hematocrit levels ≥ 39% for males and ≥ 35% for females.\n* Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study day.\n* Normal ECG.\n* A Body Mass Index (BMI-ratio of weight (W) to height (H) squared; W/H2=kg/m2) of between 18.0 and 27.0 for women and 21.4 to 29 for men.\n* Subjects must be able to read and understand instructions, as well as provide a valid informed consent.\n\nExclusion Criteria:\n\n* Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.\n* Participants with clinically significant medical disorders.\n* Women who are pregnant as determined by laboratory testing for serum beta hCG.\n* Women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures.\n* Women with a mean BMI of outside the range 18.0-27.0 and men with a BMI outside the range 21.4-29.0.\n* Participants with ferromagnetic implants or other contraindications to fMRI\n\n * Cardiac pacemakers\n * Metal clips on blood vessels (also called stents)\n * Artificial heart valves\n * Artificial arms, hands, legs, etc.\n * Brain stimulator devices\n * Implanted drug pumps\n * Ear implants\n * Eye implants or known metal fragments in eyes\n * Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)\n * Other metallic surgical hardware in vital areas\n * Certain tattoos with metallic ink\n * Transdermal patches (eg. Orthro Evra, Nicoderm CQ)\n * Metal IUD (s)\n* Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.'}, 'identificationModule': {'nctId': 'NCT01588561', 'briefTitle': 'Nicotine Related Brain Activity: The Influence of Smoking History and Blood Nicotine Levels', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'Nicotine Related Brain Activity: The Influence of Smoking History and Blood Nicotine Levels, an Exploratory Study', 'orgStudyIdInfo': {'id': '2005-p-001656'}, 'secondaryIdInfos': [{'id': 'R01DA025065', 'link': 'https://reporter.nih.gov/quickSearch/R01DA025065', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Nicotine (1.5 mg/70 kg)', 'description': 'Participants are given a siingle infusion of nicotine (1.5 mg/70 kg), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans', 'interventionNames': ['Drug: Intravenous Nicotine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline - placebo', 'description': 'Participants are given physiological saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans', 'interventionNames': ['Other: Saline - placebo']}], 'interventions': [{'name': 'Intravenous Nicotine', 'type': 'DRUG', 'otherNames': ['IV Nicotine'], 'description': 'Subjects received a single infusion of nicotine, 1.5 mg/70kg (New England Compounding Center, Framingham, MA), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.', 'armGroupLabels': ['Intravenous Nicotine (1.5 mg/70 kg)']}, {'name': 'Saline - placebo', 'type': 'OTHER', 'description': 'Subjects received a single infusion of saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.', 'armGroupLabels': ['Saline - placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Alcohol and Drug Abuse Research Center at McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}], 'overallOfficials': [{'name': 'Scott E. Lukas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}, {'name': 'Harrison G Pope, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, McLean Imaging Center', 'investigatorFullName': 'Scott Lukas', 'investigatorAffiliation': 'Mclean Hospital'}}}}