Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06948058
Status:
RECRUITING
Last Update Posted:
2025-04-29
First Post:
2025-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D040261', 'term': 'Harm Reduction'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012907', 'term': 'Smoking'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor will not know the outcome of randomized assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A 3-group design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of cigarettes per day', 'timeFrame': '2 months', 'description': 'Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.'}, {'measure': 'carbon monoxide (CO)', 'timeFrame': '2 months', 'description': 'Exhaled breath sample used to measure carbon monoxide'}, {'measure': 'number of quit attempts', 'timeFrame': '2 months', 'description': 'Number of attempts to quit smoking during the experimental period'}], 'secondaryOutcomes': [{'measure': 'product acceptability', 'timeFrame': '2 months', 'description': 'Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)'}, {'measure': 'product adherence', 'timeFrame': '2 months', 'description': 'Percentage of days using the alternative nicotine product assigned (if applicable)'}, {'measure': 'change in weight', 'timeFrame': '2 months', 'description': 'change in body weight (lbs) from baseline to 2 months'}, {'measure': 'change in waist circumference', 'timeFrame': '2 months', 'description': 'change in waist circumference, a measure of central adiposity, from baseline to 2 months'}, {'measure': 'A1c', 'timeFrame': '2 months', 'description': 'level of A1c, measured via blood sample, as a measure of glucose regulation'}, {'measure': 'interleukin-6 (IL-6)', 'timeFrame': '2 months', 'description': 'level of IL-6, measured via blood sample, as a measure of inflammation'}, {'measure': 'cotinine', 'timeFrame': '2 months', 'description': 'level of cotinine, measured via blood sample, as a measure of nicotine exposure'}, {'measure': 'diastolic blood pressure', 'timeFrame': '2 months', 'description': 'diastolic blood pressure measured using a cuff'}, {'measure': 'systolic blood pressure', 'timeFrame': '2 months', 'description': 'systolic blood pressure measured using a cuff'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'electronic cigarettes', 'harm reduction'], 'conditions': ['Smoking Cessation', 'Obesity and Obesity-related Medical Conditions']}, 'descriptionModule': {'briefSummary': 'This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.', 'detailedDescription': 'The purpose of this study is to provide preliminary information on the effect of electronic cigarettes (EC) and nicotine replacement therapy (NRT) among SWO. This study will randomize up to 60 individuals who smoke cigarettes with comorbid obesity (SWO) to receive (1) electronic cigarettes (EC), (2) nicotine replacement therapy (NRT), or 3) a no-product control (CON) condition for 8 weeks. Assessments will occur at baseline, and 1, 2, and 3-months follow-up, aiming: 1) To compare EC, NRT, and CON on smoking, exhaled carbon monoxide, and number of quit attempts; 2) To compare EC and NRT on acceptability and adherence; 3) To compare EC, NRT, and CON effects on weight, central adiposity, glucose regulation, inflammation, cotinine, and blood pressure at follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)\n* smoked ≥ 5 cigarettes/day during the past year\n* 21 or older (due to minimum legal age EC restrictions)\n* exhaled breath carbon monoxide (CO) level \\> 6 ppm at Baseline (BL) (to confirm self-reported smoking)\n* willing to use EC or NRT for 8 weeks\n* access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)\n\nExclusion Criteria:\n\n* received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),\n* currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)\n* hospitalized for mental illness in past 30 days\n* heart-related event (e.g., heart attack, severe angina) in past 30 days\n* residing with another person currently enrolled in the study\n* pregnant, nursing, or planning to become pregnant in the next 6 months\n* medical contraindication for study or product use (e.g., allergy to adhesives)\n* taken prescription weight loss medication in the last 30 days'}, 'identificationModule': {'nctId': 'NCT06948058', 'acronym': 'CRESCENT', 'briefTitle': 'Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy', 'orgStudyIdInfo': {'id': 'STUDY00000326'}, 'secondaryIdInfos': [{'id': 'P20GM130414', 'link': 'https://reporter.nih.gov/quickSearch/P20GM130414', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic Cigarette (EC) Condition', 'description': 'Participants in this condition will receive the EC intervention.', 'interventionNames': ['Other: Electronic Cigarettes (EC)']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine Replacement Therapy Condition', 'description': 'Participants in this condition will receive the NRT intervention.', 'interventionNames': ['Other: Nicotine replacement therapy (NRT)']}, {'type': 'NO_INTERVENTION', 'label': 'No-Product Control Condition (CON)', 'description': 'Participants in this condition will not receive any alternate nicotine product.'}], 'interventions': [{'name': 'Electronic Cigarettes (EC)', 'type': 'OTHER', 'description': 'Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to EC for 8 weeks, with EC provided.', 'armGroupLabels': ['Electronic Cigarette (EC) Condition']}, {'name': 'Nicotine replacement therapy (NRT)', 'type': 'OTHER', 'description': 'Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to combination NRT (transdermal + oral) for 8 weeks, with NRT provided.', 'armGroupLabels': ['Nicotine Replacement Therapy Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'CRESCENT Research Staff', 'role': 'CONTACT', 'email': 'CRESCENT@brown.edu', 'phone': '401-203-5339'}], 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'CRESCENT Study Research Staff', 'role': 'CONTACT', 'email': 'CRESCENT@brown.edu', 'phone': '401-203-5339'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Clinical Laboratory Core data collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication, with no prespecified end date.', 'ipdSharing': 'YES', 'description': 'Deidentified data will be kept and used for future research on chronic disease and substance use.', 'accessCriteria': 'After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}