Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT01566994
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Population Cessation Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking cessation (quit) rate', 'timeFrame': '24 months', 'description': 'Self-report point prevalence abstinence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['smoking cessation'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement Therapy and Transtheoretical tailored interventions produces an increasing treatment trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and population cessation generally. These recruitment and intervention strategies require limited resources from health care providers and could be readily disseminable to other health care systems for application with populations of smokers, especially unmotivated smokers who have been understudied and underserved.', 'detailedDescription': 'This proposal addresses major gaps in research for nicotine addiction treatments for entire populations of smokers and for the 80% who are not motivated to quit. Nicotine addiction is just like other drug addictions in terms of breaking the addiction cycle. Researchers and providers differ on whether treatment emphasis should be on clinician-based counseling, biologically-based medications, computer-based tailored communications or a combination of these. There is a lack of comparative research on population treatments to compare effectiveness, cost-effectiveness and enhancement of quality of life. Such comparative research would provide health care systems and providers with evidence on how to best serve entire populations of smokers, especially unmotivated smokers who are seriously underserved. This research will compare the four most highly recommended treatments: 1. Motivation Enhancement Therapy (MET) plus NRT; 2.Tailored communications based on the Transtheoretical Model (TTM), and 3. The combination of these treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoker\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01566994', 'briefTitle': 'Comparing Population Cessation Services', 'organization': {'class': 'OTHER', 'fullName': 'University of Rhode Island'}, 'officialTitle': 'Comparing Population Cessation Services With Emphasis on Unmotivated Smokers', 'orgStudyIdInfo': {'id': 'DA022291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TTM Tailored', 'interventionNames': ['Behavioral: TTM Tailored']}, {'type': 'EXPERIMENTAL', 'label': 'Motivational Enhancement Therapy', 'interventionNames': ['Behavioral: Motivational Enhancement Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Integrated Treatment', 'interventionNames': ['Behavioral: Integrated Treatment']}], 'interventions': [{'name': 'TTM Tailored', 'type': 'BEHAVIORAL', 'otherNames': ['TTM Expert System'], 'description': 'This treatment is tailored on three occasions (baseline, 6, and 24 weeks) on each of the 14 TTM variables. This treatment provides both normative and ipsative feedback on each of the variables found to predict progress across specific stages', 'armGroupLabels': ['TTM Tailored']}, {'name': 'Motivational Enhancement Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['MET'], 'description': 'This intervention will be driven by the manual developed by Carpenter et al. (2004) based on the USPHS recommendations for smokers not motivated to quit and for those who become ready to set a quit date.', 'armGroupLabels': ['Motivational Enhancement Therapy']}, {'name': 'Integrated Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['Combined treatment'], 'description': 'This enhanced condition would combine MET, Reduction Counseling and NRT and TTM Tailoring.', 'armGroupLabels': ['Integrated Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02881', 'city': 'Kingston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'University of Rhode Island', 'geoPoint': {'lat': 41.48038, 'lon': -71.52256}}], 'overallOfficials': [{'name': 'James O Prochaska, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Rhode Island'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rhode Island', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James O. Prochaska', 'investigatorAffiliation': 'University of Rhode Island'}}}}