Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-02 @ 12:13 AM
Study NCT ID:
NCT03042650
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2016-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Referral to Reduce Smoking in Probationers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2016-12-29', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Motivation measured by Readiness to Quit Ladder', 'timeFrame': '6 Months', 'description': 'Increased Motivation to quit cigarette smoking in probationers as indicated by a change in Readiness to Quit Ladder'}, {'measure': 'Motivation measured by QSU-Brief Questionnaire for Smoking Urges', 'timeFrame': '6 Months', 'description': 'Increased Motivation to quit cigarette smoking in probationers as indicated by a change in QSU-Brief Questionnaire for Smoking Urges'}], 'primaryOutcomes': [{'measure': 'Motivation measured by Fagerstrom Test', 'timeFrame': '6 Months', 'description': 'Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence'}], 'secondaryOutcomes': [{'measure': 'Change in Timeline Follow-back Calendar', 'timeFrame': '6 Months', 'description': 'Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation', 'Substance Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Intensive Referral Intervention increases motivation to quit cigarette smoking and quitting-related behaviors in probationers and also to determine if Intensive Referral Intervention improves short-term substance use outcomes in probationers with substance use disorder.', 'detailedDescription': 'This is a longitudinal study of adults on probation who have a Substance Use Disorder (SUD) and smoke cigarettes. One-half of probation officers will be trained in the Intensive Referral Intervention (IRI) while one-half will deliver Standard Practice which is to encourage support group attendance. Research staff will assess fidelity to the IRI in trained probation officers. The investigators propose to enroll 150 probationers over a four month period and complete 3 and 6-month follow-up interviews to assess smoking and substance use measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CBR-MH Probationers in Douglas County, NE\n* SUD\n* daily cigarette smoker\n\nExclusion Criteria:\n\n* Under guardianship\n* unwilling to provide personal contact information\n* unable to pass Mini-Cog'}, 'identificationModule': {'nctId': 'NCT03042650', 'briefTitle': 'Intensive Referral to Reduce Smoking in Probationers', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Intensive Referral to Reduce Smoking in Probationers', 'orgStudyIdInfo': {'id': '0018-16-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Referral Intervention Group', 'description': 'Intensive Referral Intervention will by done by trained probation officers', 'interventionNames': ['Behavioral: Intensive Referral Intervention Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Practice Facilitated Group', 'description': 'Standard Current Practice will be provided by untrained probation officers', 'interventionNames': ['Behavioral: Standard Practice Facilitated Group']}], 'interventions': [{'name': 'Intensive Referral Intervention Group', 'type': 'BEHAVIORAL', 'description': 'The Intensive Referral Intervention Group will review a series of pamphlets regarding participation in 12-step meetings as well as smoking cessation that will be presented in a group setting to probationers in 3 sessions.', 'armGroupLabels': ['Intensive Referral Intervention Group']}, {'name': 'Standard Practice Facilitated Group', 'type': 'BEHAVIORAL', 'description': 'The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.', 'armGroupLabels': ['Standard Practice Facilitated Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Unversity of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Kathleen M Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}