{"protocolSection":{"identificationModule":{"nctId":"NCT04388319","orgStudyIdInfo":{"id":"BuZonE"},"organization":{"fullName":"Rose Research Center, LLC","class":"INDUSTRY"},"briefTitle":"Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes","officialTitle":"Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes","acronym":"BuZonE"},"statusModule":{"statusVerifiedDate":"2022-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-05-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-06-04","type":"ACTUAL"},"completionDateStruct":{"date":"2021-09-15","type":"ACTUAL"},"studyFirstSubmitDate":"2020-05-11","studyFirstSubmitQcDate":"2020-05-11","studyFirstPostDateStruct":{"date":"2020-05-14","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-03-01","resultsFirstSubmitQcDate":"2022-03-01","resultsFirstPostDateStruct":{"date":"2022-03-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-03-28","lastUpdatePostDateStruct":{"date":"2022-04-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Rose Research Center, LLC","class":"INDUSTRY"},"collaborators":[{"name":"Foundation for a Smoke Free World INC","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This single-group, small-scale, open-label study (N= 25 to 50) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CC) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline data on use of combustible cigarettes. Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide (100 mg/daily) and will begin extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) in addition to continued use of the G6. At each visit, participants will receive enough zonisamide, bupropion, and Halo G6 cartomizers to last until their next study visit. Halo G6 and combination zonisamide and bupropion use will continue until the participant returns for the End-of-Study visit (V7)."},"conditionsModule":{"conditions":["Smoking Cessation"],"keywords":["e-cigarette","zonisamide","bupropion","combustible cigarettes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":26,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Combination zonisamide and bupropion with e-cigarette","type":"EXPERIMENTAL","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.","interventionNames":["Drug: Zonisamide","Drug: Bupropion","Other: Halo G6 e-cigarette"]}],"interventions":[{"type":"DRUG","name":"Zonisamide","description":"Zonisamide (100 mg/daily) for 12 weeks.","armGroupLabels":["Combination zonisamide and bupropion with e-cigarette"],"otherNames":["zonegran"]},{"type":"DRUG","name":"Bupropion","description":"Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.","armGroupLabels":["Combination zonisamide and bupropion with e-cigarette"],"otherNames":["wellbutrin","Zyban"]},{"type":"OTHER","name":"Halo G6 e-cigarette","description":"G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.","armGroupLabels":["Combination zonisamide and bupropion with e-cigarette"],"otherNames":["e-cigarette"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants That Completely Switched From Combustible Cigarettes to Halo G6 E-Cigarettes","description":"Defined as self-report of no cigarette smoking (not even a puff), confirmed by an expired air CO reading of less than 5 ppm.","timeFrame":"Weeks 8-11 post-quit date (weeks 10-13 post baseline)"}],"secondaryOutcomes":[{"measure":"Point Abstinence From Combustible Cigarettes","description":"Assessed by self-report utilizing an automated SMS messaging system.","timeFrame":"Six months post switch day (approximately 6 months post baseline)"},{"measure":"Change in Rewarding Effects of Smoking Combustible Cigarettes","description":"Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, compared between cigarettes smoked after meals versus all others smoked during the day, examining how this difference changes after zonisamide/bupropion usage. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure the following subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion.","timeFrame":"First week compared to after start of study drugs (Weeks 2-13 post baseline)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Has signed the ICF and is able to read and understand the information provided in the ICF.\n2. Is 21 to 65 years of age (inclusive) at screening.\n3. Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months.\n4. Has an expired air CO reading of at least 10 ppm at screening.\n5. Interested in switching to an electronic cigarette.\n6. Willing and able to comply with the requirements of the study.\n7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.\n\nExclusion Criteria:\n\n1. Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).\n2. PHQ-9 score greater than 9, or a score greater than 0 on item #9 (\"Thoughts that you would be better off dead, or of hurting yourself in some way\") at screening.\n3. Planned use of an FDA-approved smoking cessation product during the study.\n4. High blood pressure (systolic \\> 150 mmHg or diastolic \\>95 mmHg) at screening.\n5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.\n6. Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.\n7. Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.\n8. Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.\n9. Use of any of these products in the past 30 days:\n\n   1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates);\n   2. Experimental (investigational) drugs that are unknown to participant;\n   3. Chronic opiate use.\n10. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for \"Black \\& Mild\" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.\n11. Pregnant or nursing (by self-report) or has a positive pregnancy test.\n12. Enrollment requirements met.","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Rose Research Center","city":"Charlotte","state":"North Carolina","zip":"28262","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"Rose Research Center","city":"Raleigh","state":"North Carolina","zip":"27617","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Two participants were enrolled into the study but discontinued prior to taken any study drug.","groups":[{"id":"FG000","title":"Combination Zonisamide and Bupropion With E-cigarette","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.\n\nZonisamide: Zonisamide (100 mg/daily) for 12 weeks.\n\nBupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.\n\nHalo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."}],"periods":[{"title":"Enrolled in Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}]},{"title":"Treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.","groups":[{"id":"BG000","title":"Combination Zonisamide and Bupropion With E-cigarette","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.\n\nZonisamide: Zonisamide (100 mg/daily) for 12 weeks.\n\nBupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.\n\nHalo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"26"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"45.1","spread":"9.75"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"8"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"18"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"25"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"18"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"26"}]}]}]},{"title":"Cigarettes smoked per day (CPD)","populationDescription":"Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Cigs smoked per day","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"21.2","spread":"6.64"}]}]}]},{"title":"FTND -- The Fagerström Test for Nicotine Dependence Score","description":"The Fagerström Test for Nicotine Dependence is a six-item questionnaire developed by Karl-Olov Fagerström and is used to determine someone's level of nicotine dependence. The scores obtained on the test allow the classification of nicotine dependence in three different levels: mild (0-3 points), moderate (4-6 points), and severe (7 -10 points).","populationDescription":"Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"6.1","spread":"1.82"}]}]}]},{"title":"Expired air carbon monoxide (CO)","populationDescription":"Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"ppm","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"26.0","spread":"9.19"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants That Completely Switched From Combustible Cigarettes to Halo G6 E-Cigarettes","description":"Defined as self-report of no cigarette smoking (not even a puff), confirmed by an expired air CO reading of less than 5 ppm.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 8-11 post-quit date (weeks 10-13 post baseline)","groups":[{"id":"OG000","title":"Combination Zonisamide and Bupropion With E-cigarette","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.\n\nZonisamide: Zonisamide (100 mg/daily) for 12 weeks.\n\nBupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.\n\nHalo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]}]},{"type":"SECONDARY","title":"Point Abstinence From Combustible Cigarettes","description":"Assessed by self-report utilizing an automated SMS messaging system.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Six months post switch day (approximately 6 months post baseline)","groups":[{"id":"OG000","title":"Combination Zonisamide and Bupropion With E-cigarette","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.\n\nZonisamide: Zonisamide (100 mg/daily) for 12 weeks.\n\nBupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.\n\nHalo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}]}]},{"type":"SECONDARY","title":"Change in Rewarding Effects of Smoking Combustible Cigarettes","description":"Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, compared between cigarettes smoked after meals versus all others smoked during the day, examining how this difference changes after zonisamide/bupropion usage. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure the following subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"First week compared to after start of study drugs (Weeks 2-13 post baseline)","groups":[{"id":"OG000","title":"Combination Zonisamide and Bupropion With E-cigarette","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.\n\nZonisamide: Zonisamide (100 mg/daily) for 12 weeks.\n\nBupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.\n\nHalo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"}]}],"classes":[{"title":"CEQ Satisfaction Scale","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"1.2"}]}]},{"title":"CEQ Psych Reward Scale","categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"1.1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"During 13 week study period.","eventGroups":[{"id":"EG000","title":"Combination Zonisamide and Bupropion With E-cigarette","description":"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.\n\nZonisamide: Zonisamide (100 mg/daily) for 12 weeks.\n\nBupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.\n\nHalo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.","deathsNumAffected":0,"deathsNumAtRisk":24,"seriousNumAffected":0,"seriousNumAtRisk":24,"otherNumAffected":22,"otherNumAtRisk":24}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":24}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":24}]},{"term":"Throat irritation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":24}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":24}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24}]},{"term":"Tinnitus","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24}]},{"term":"Dizziness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24}]},{"term":"Aversion to cigarettes","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24}]},{"term":"Anxiety","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24}]},{"term":"Elevated blood pressure","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":24}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Jed E. Rose","organization":"Rose Research Center","email":"jed.rose@roseresearchcenter.com","phone":"9193282345"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2021-02-16","uploadDate":"2022-03-01T14:16","filename":"Prot_SAP_000.pdf","size":1462596}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"},{"id":"D000072137","term":"Vaping"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D012907","term":"Smoking"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078305","term":"Zonisamide"},{"id":"D016642","term":"Bupropion"},{"id":"D066300","term":"Electronic Nicotine Delivery Systems"}],"ancestors":[{"id":"D013449","term":"Sulfonamides"},{"id":"D000577","term":"Amides"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D013450","term":"Sulfones"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D007555","term":"Isoxazoles"},{"id":"D001393","term":"Azoles"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D000074602","term":"Smoking Devices"},{"id":"D008420","term":"Manufactured Materials"},{"id":"D013676","term":"Technology, Industry, and Agriculture"}]}},"hasResults":true}