Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT03075202
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2017-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-03-04', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Displacement', 'timeFrame': '3-months', 'description': 'The primary endpoint of this study is the proportion of study participants with a self-reported complete displacement from tobacco cigarette smoking - not even a puff in between study visits, along with confirmatory eCO values ≤10 ppm at each study visit. These participants will be referred to as "Displacers". Discrepancies between self-report and eCO measures will be handled on a case-by-case basis. To assure an accurate eCO reading participants will be asked not to smoke cigarettes within one hour of the study visit.'}], 'secondaryOutcomes': [{'measure': 'Partial Displacement', 'timeFrame': '3-months', 'description': 'Partial displacement will be defined as a minimization in cigarette consumption by ≥50% in the number of tobacco cigarettes smoked per day from baseline to the final visit (week 12) by participants\' self-report together with an eCO decline from baseline.. The measures will be taken at each study visit. These participants will be referred to as "Partial Displacers". Discrepancies between self-report and eCO measures will be handled on a case-by-case basis. To assure an accurate eCO reading participants will be asked not to smoke cigarettes within one hour of the study visit.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Smoking', 'E-cigarette'], 'conditions': ['Schizophrenia and Related Disorders']}, 'descriptionModule': {'briefSummary': 'It is well established in the scientific literature that people with schizophrenia smoke tobacco cigarettes at rates up to three times that of the general population, relapse more frequently, and die an average of 25 years earlier from cigarette smoking and other life-style attributable illnesses. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide and new research suggests that e-cigarettes are appealing to smokers with schizophrenia. There is a paucity of research focused on the experience of smokers with schizophrenia who decide to try an e-cigarette. A well-designed prospective-observational study is needed to learn more about the influence of e-cigarette use on cigarette smoking behavior and mental and physical health among smokers with schizophrenia. In response, the investigators have designed a study titled, Role of an electronic cigarette on smoking displacement in smokers with schizophrenia: A prospective 3-month pilot study (SchizEcig).', 'detailedDescription': "This is a prospective 3 month pilot study to observe cigarette use behavior among people with a schizophrenia spectrum disorder diagnosis who smoke conventional tobacco cigarettes, do not intend to reduce or quit smoking, and are invited to use an e-cigarette. The investigators are interested to know if e-cigarette use is associated with cigarette smoking displacement. Displacement is defined as switching from conventional tobacco cigarettes to e-cigarettes. The investigators will also monitor for physical and mental health, including blood pressure, weight, and scores from the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS) as well as any reported adverse events participants' feel are attributed to e-cigarette use and participants' perceptions of the sensory experience associated with e-cigarette use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants, age 21 to 65 years, will have a DSM 5 schizophrenia spectrum disorder diagnosis without evidence of exacerbation of illness as indicated by no relapse to hospitalization within the last three months and no change in their antipsychotic treatment within the last month. Participants will smoke 20 or more conventional tobacco cigarettes per day and at least 100 cigarettes in their lifetime and do not intend to reduce or quit smoking.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of a schizophrenia spectrum disorder\n\nNon-hospitalized persons\n\nRegular smokers who report smoking 20 or more cigarettes per day who have smoked at least 100 cigarettes in their lifetime, and are not intending to reduce or quit\n\nHas agreed to try an e-cigarette\n\nMust be able to provide written informed consent\n\nMust be able to read, write and communicate in English proficiently\n\nMust have access to a computer with internet\n\nMust have the ability to work a computer and navigate the internet easily\n\nExclusion Criteria:\n\nNon-smokers Persons without a schizophrenia spectrum disorder diagnosis\n\nHospitalized persons\n\nCardio vascular disease\n\nRespiratory disease\n\nUse of smokeless tobacco or any other tobacco products besides cigarettes.\n\nUse of nicotine replacement therapy or other smoking cessation pharmaco-therapies within the last 3 months\n\nPregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03075202', 'briefTitle': 'Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia: A Prospective 3-month Pilot Study', 'orgStudyIdInfo': {'id': '1607017418'}}, 'armsInterventionsModule': {'interventions': [{'name': 'e-cigarette, brand name JUUL', 'type': 'DEVICE', 'description': 'This is not an experimental study/trial, rather a prospective observational study. Device will be offered to cohort, but they are not mandated to take or use the device.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical and Translational Science Center, Weill Cornell Medicine, 525 E 68th Street, F-260', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jennifer DiPiazza-Sileo, PhD, PMHNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunter College at The City University of New York'}, {'name': 'Caponnetto Pasquale, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catania'}, {'name': 'Jason J Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data may be available to some collaborating researchers, but not all.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hunter College of The City University of New York', 'class': 'OTHER'}, {'name': 'University of Catania', 'class': 'OTHER'}, {'name': 'University of Stirling', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}