Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 6:55 PM
Study NCT ID:
NCT04396834
Status:
TERMINATED
Last Update Posted:
2023-03-20
First Post:
2020-02-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanisms of Lorcaserin for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506658', 'term': 'lorcaserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christian_hendershot@med.unc.edu', 'phone': '(919) 962-5565', 'title': 'Christian Hendershot', 'organization': 'UNC-Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Lorcaserin', 'description': 'Lorcaserin (10mg BID) for 7 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo pill (BID) for 7 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Shingles', 'notes': 'Participant reported incident of shingles approximately one week following participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Lapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': 'Lorcaserin (10mg BID)\n\nLorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pill (BID)\n\nPlacebo oral tablet: Placebo Oral Tablet (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills', 'description': 'Duration (in minutes) until lapsing to smoking during a 50-minute period', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was halted after randomizing the first two participants.'}, {'type': 'PRIMARY', 'title': 'Laboratory Cigarette Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': 'Lorcaserin (10mg BID)\n\nLorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pill (BID)\n\nPlacebo oral tablet: Placebo Oral Tablet (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '3', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills', 'description': 'Number of cigarettes consumed during a 60-minute period', 'unitOfMeasure': 'number of cigarettes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was halted after randomizing the first two participants.'}, {'type': 'SECONDARY', 'title': 'Impulsivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': 'Lorcaserin (10mg BID)\n\nLorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pill (BID)\n\nPlacebo oral tablet: Placebo Oral Tablet (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '280.2', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '255.4', 'spread': '34.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills.', 'description': 'Performance on a behavioral measure of impulsivity, the stop signal task. Reported is the stop signal reaction time, the number of milliseconds required to activate the "stop" process in the stop signal task.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was halted after randomizing the first two participants.'}, {'type': 'SECONDARY', 'title': 'Reward Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': 'Lorcaserin (10mg BID)\n\nLorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pill (BID)\n\nPlacebo oral tablet: Placebo Oral Tablet (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '.89', 'spread': '.51', 'groupId': 'OG000'}, {'value': '.80', 'spread': '.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills.', 'description': 'Performance on a behavioral measure of reward sensitivity (response bias measure on a signal detection task). Response bias is computed by the following equation: 1/2 \\* log((# correct stim 1 \\* # incorrect stim 2)/(# incorrect stim 1 \\* # correct stim 2))\n\nStimulus 1 is associated with a higher proportion of correct feedback than Stimulus 2, and by computing the ratio above, we are able to determine the response bias of the participant. The response bias measure provides an objective measure of reward sensitivity (i.e., the degree to which participants are biased towards choosing the more frequently rewarded response).', 'unitOfMeasure': 'log(ratio)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was halted after randomizing the first two participants.'}, {'type': 'SECONDARY', 'title': 'Daily Cigarette Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lorcaserin', 'description': 'Lorcaserin (10mg BID)\n\nLorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo pill (BID)\n\nPlacebo oral tablet: Placebo Oral Tablet (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.79', 'spread': '.30', 'groupId': 'OG000'}, {'value': '8.79', 'spread': '.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 7 days of medication or during 7 days of placebo pills (difference score between weeks).', 'description': 'Cigarettes smoked per day', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was halted after randomizing the first two participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lorcaserin First, Then Placebo', 'description': 'Participants first receive lorcaserin (10 mg BID) for 7 days. After a washout period of 7 days, they then receive placebo tablets (BID) for 7 days.'}, {'id': 'FG001', 'title': 'Placebo First, Then Lorcaserin', 'description': 'Participants first receive placebo (BID) for 7 days. After a washout period of 7 days, they then receive lorcaserin (10 mg BID) for 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three participants provided informed consent. Due to the study being canceled, only two participants were assigned to condition.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lorcaserin First, Then Placebo', 'description': 'Lorcaserin (10mg BID) for 7 days, then placebo pill (BID) for 7 days'}, {'id': 'BG001', 'title': 'Placebo First, Then Lorcaserin', 'description': 'Placebo pill (BID) for 7 days, then lorcaserin (10mg BID) for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two 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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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', 'populationDescription': 'The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two 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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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', 'populationDescription': 'The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.'}], 'populationDescription': 'The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-10', 'size': 489480, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-05T10:41', 'hasProtocol': True}, {'date': '2019-09-10', 'size': 258047, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-05T10:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Medication removed from the U.S. market by the The Food and Drug Administration', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2020-02-03', 'resultsFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-14', 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Lapse', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills', 'description': 'Duration (in minutes) until lapsing to smoking during a 50-minute period'}, {'measure': 'Laboratory Cigarette Smoking', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills', 'description': 'Number of cigarettes consumed during a 60-minute period'}], 'secondaryOutcomes': [{'measure': 'Impulsivity', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills.', 'description': 'Performance on a behavioral measure of impulsivity, the stop signal task. Reported is the stop signal reaction time, the number of milliseconds required to activate the "stop" process in the stop signal task.'}, {'measure': 'Reward Sensitivity', 'timeFrame': 'Laboratory session following 7 days of medication or placebo pills.', 'description': 'Performance on a behavioral measure of reward sensitivity (response bias measure on a signal detection task). Response bias is computed by the following equation: 1/2 \\* log((# correct stim 1 \\* # incorrect stim 2)/(# incorrect stim 1 \\* # correct stim 2))\n\nStimulus 1 is associated with a higher proportion of correct feedback than Stimulus 2, and by computing the ratio above, we are able to determine the response bias of the participant. The response bias measure provides an objective measure of reward sensitivity (i.e., the degree to which participants are biased towards choosing the more frequently rewarded response).'}, {'measure': 'Daily Cigarette Smoking', 'timeFrame': 'During 7 days of medication or during 7 days of placebo pills (difference score between weeks).', 'description': 'Cigarettes smoked per day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Identifying new medication options is critical for curbing the health burdens of cigarette smoking. Currently approved smoking cessation medications act on nicotinic receptors, and additional work is needed to identify medications with alternate pharmacological targets. Based on evidence that the serotonin system plays a role in nicotine consumption and relapse, this study will examine whether a selective serotonin medication alters smoking-related behaviors and responses to cigarette smoking under controlled conditions, informing its potential utility for smoking cessation.', 'detailedDescription': 'Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those with novel pharmacological targets, is a critical public health priority. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in the regulation of reward- related behavior, including drug seeking, in part reflecting its modulatory role in dopamine (DA) function. Recent studies show that targeted manipulation of the serotonin 5-HT2C receptor alters drug-related behavior; in particular, 5-HT2C receptor agonists are shown to reduce nicotine intake and reinstatement. Of the selective 5-HT2C receptor agonists, lorcaserin has the best near-term potential for repurposing as a smoking cessation therapy, having been approved by the U.S. Food and Drug Administration for weight management.\n\nPreclinical findings implicate several potential behavioral mechanisms by which 5-HT2C receptor agonists might reduce drug intake, including drug-specific processes (e.g., incentive salience of drug cues, self-administration, reinstatement) and drug-nonspecific behaviors (e.g., reductions in impulsivity). To date, potential mechanisms of 5-HT2C receptor agonists have not been characterized in human studies. Given emerging interest in lorcaserin as a novel smoking cessation therapy, further studies are needed to evaluate its efficacy profile, including studies to evaluate candidate treatment mechanisms. This human laboratory investigation will examine the effects of lorcaserin vs. placebo on relapse-related outcomes using a double-blind, within-subjects, crossover design. Impulsivity subdomains will also be examined as candidate mechanisms for medication effects. By evaluating an approved 5-HT2C agonist with emergent efficacy for smoking cessation, this project has near-term potential to inform clinical applications of 5-HT2C agonists for addiction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18-65\n2. smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence \\> 90 days\n3. biochemical verification of smoking status\n4. at least low to moderate nicotine dependence\n5. reporting long-term motivation to quit smoking\n6. willingness to take study pills and complete study procedures\n7. willingness to complete lab sessions involving cigarette smoking\n\nExclusion Criteria:\n\n1. meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder\n2. recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen\n3. past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes\n4. past 30-day use of SSRIs, other psychiatric medications, or weight control medications\n5. lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)\n6. significant medical or neurological illness, including severe hepatic impairment or cirrhosis, or insulin dependent diabetes\n7. actively engaged in smoking cessation treatments or a smoking cessation attempt (or intent to start an attempt in the next 90 days)\n8. interested in quitting smoking immediately (i.e., in the next two months)\n9. Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin\n10. body mass index (BMI) under normal range (BMI \\< 18 kg/m2)\n11. history of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heart attack, stroke, unstable angina\n12. abnormal electrocardiogram (ECG) results\n13. nursing, pregnant, or anticipating pregnancy\n14. history of suicide attempt or recent suicidal thoughts (intent or plan) in the last month\n15. Plans to travel outside of the local area during the study period, or inability to commit to entire duration of study'}, 'identificationModule': {'nctId': 'NCT04396834', 'briefTitle': 'Mechanisms of Lorcaserin for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'The Mind Research Network'}, 'officialTitle': 'Behavioral Mechanisms of Lorcaserin Treatment for Smoking Cessation', 'orgStudyIdInfo': {'id': '04619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lorcaserin first, then placebo', 'description': 'Participants first receive lorcaserin (10 mg BID) for 7 days. After a washout period of 7 days, they then receive placebo tablets (BID) for 7 days.', 'interventionNames': ['Drug: Lorcaserin Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo first, then lorcaserin', 'description': 'Participants first receive placebo (BID) for 7 days. After a washout period of 7 days, they then receive lorcaserin (10 mg BID) for 7 days.', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Lorcaserin Oral Tablet', 'type': 'DRUG', 'otherNames': ['Belviq'], 'description': 'Lorcasering 10mg Oral Tablet (BID)', 'armGroupLabels': ['Lorcaserin first, then placebo']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'otherNames': ['Placebo pill'], 'description': 'Placebo Oral Tablet (BID)', 'armGroupLabels': ['Placebo first, then lorcaserin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'The Mind Research Network', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Christian Hendershot, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mind Research Network'}, {'name': 'Eric Claus, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mind Research Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Mind Research Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}