Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-03 @ 6:48 PM
Study NCT ID:
NCT01259466
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2010-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marney.white@yale.edu', 'phone': '203-785-4349', 'title': 'Dr. Marney A. White', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Behavioral Treatment + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Health Education + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Verified Smoking Cessation (Abstinence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Treatment + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}, {'id': 'OG001', 'title': 'Health Education + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-treatment (12-weeks)', 'description': 'Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \\<10ppm)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Treatment + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}, {'id': 'OG001', 'title': 'Health Education + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (12 weeks)', 'description': '% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) \\* 100', 'unitOfMeasure': 'Percent weight change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Behavioral Treatment + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}, {'id': 'FG001', 'title': 'Health Education + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Behavioral Treatment + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}, {'id': 'BG001', 'title': 'Health Education + Nicotine Replacement', 'description': 'Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks'}, {'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': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '45.9', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2010-11-11', 'resultsFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2010-12-10', 'lastUpdatePostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-27', 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Verified Smoking Cessation (Abstinence)', 'timeFrame': 'Post-treatment (12-weeks)', 'description': 'Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \\<10ppm)'}], 'secondaryOutcomes': [{'measure': 'Percent Weight Change', 'timeFrame': 'Post-treatment (12 weeks)', 'description': '% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) \\* 100'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Overweight', 'Obesity', 'Internet treatment'], 'conditions': ['Smoking Cessation', 'Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoking 10 or more cigarettes per day\n* Regular access to the internet\n* BMI\\>=25\n\nExclusion Criteria:\n\n* Type I diabetes or Type II diabetes requiring medication\n* Alcohol or drug dependence within the past year\n* Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months\n* Uncontrolled hypertension\n* Severe chronic obstructive pulmonary disease\n* Use of an investigational drug within 30 days or current participation in another clinical trial\n* Current use of tobacco products other than cigarettes or use of marijuana\n* Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment\n* Use of a medication that might affect weight or appetite\n* History of allergic reactions to adhesives.'}, 'identificationModule': {'nctId': 'NCT01259466', 'briefTitle': 'Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers', 'orgStudyIdInfo': {'id': '1001006181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral + Nicotine Patch', 'description': 'Cognitive Behavioral Therapy + Nicotine Replacement Patch', 'interventionNames': ['Drug: Nicotine patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education + Nicotine Patch', 'description': 'Health Education + Nicotine Replacement Patch', 'interventionNames': ['Drug: Nicotine patch']}], 'interventions': [{'name': 'Nicotine patch', 'type': 'DRUG', 'otherNames': ['Nicotine replacement'], 'description': 'Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks', 'armGroupLabels': ['Cognitive Behavioral + Nicotine Patch', 'Health Education + Nicotine Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Marney A White, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Marney A. White', 'investigatorAffiliation': 'Yale University'}}}}