Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-30 @ 1:13 PM
Study NCT ID:
NCT01181661
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2010-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Group Contingency Management to Promote Smoking Abstinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-23', 'studyFirstSubmitDate': '2010-08-12', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath CO', 'timeFrame': '8 weeks', 'description': 'Twice daily breath CO samples obtained during baseline and treatment'}], 'secondaryOutcomes': [{'measure': 'Point prevalence measure of abstinence', 'timeFrame': 'at the end of treatment (approximately week 4) and at 3 month follow-up', 'description': 'Abstinence will be defined as: (a) CO sample ≤ 4 ppm; (b) cotinine \\< 50 ng/ml; and (c) reporting not smoking, not even a puff in the last 7 days.'}, {'measure': 'Duration of abstinence during treatment.', 'timeFrame': '3 weeks', 'description': 'The longest duration of sustained abstinence (CO ≤ 4 ppm) based on the twice-daily breath samples during the treatment period.'}, {'measure': 'Rate of social exchanges', 'timeFrame': '3 weeks', 'description': 'The number of comments posted on the discussion forum during treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cigarette', 'Smoking', 'Nicotine', 'Contingency Management', 'Voucher Reinforcement', 'Smoking Abstinence', 'Internet', 'Internet-based Treatment', 'Group Contingencies'], 'conditions': ['Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-reported smoker\n* ability to use the Internet\n* permission to contact applicant by phone\n\nExclusion Criteria:\n\n* self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study\n* inability to avoid high levels of ambient CO (e.g., occupational exposure; lives with a another smoker who smokes in the home)'}, 'identificationModule': {'nctId': 'NCT01181661', 'briefTitle': 'Internet-based Group Contingency Management to Promote Smoking Abstinence', 'organization': {'class': 'OTHER', 'fullName': 'National Development and Research Institutes, Inc.'}, 'officialTitle': 'Internet-based Group Contingency Management to Promote Smoking Abstinence', 'orgStudyIdInfo': {'id': '1R21DA029162', 'link': 'https://reporter.nih.gov/quickSearch/1R21DA029162', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R21DA029162', 'link': 'https://reporter.nih.gov/quickSearch/1R21DA029162', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full Group Contingency', 'description': 'This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher.', 'interventionNames': ['Behavioral: Full Group Contingency']}, {'type': 'EXPERIMENTAL', 'label': 'Mixed Group Contingency', 'description': 'This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples.', 'interventionNames': ['Behavioral: Mixed Group Contingency']}], 'interventions': [{'name': 'Full Group Contingency', 'type': 'BEHAVIORAL', 'description': 'This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher.', 'armGroupLabels': ['Full Group Contingency']}, {'name': 'Mixed Group Contingency', 'type': 'BEHAVIORAL', 'description': 'This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples.', 'armGroupLabels': ['Mixed Group Contingency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'National Development and Research Institutes', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jesse Dallery, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Development and Research Institutes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Development and Research Institutes, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jesse Dallery', 'investigatorAffiliation': 'National Development and Research Institutes, Inc.'}}}}