Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT03527667
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incentivized Smoking Cessation for Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-arm randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of CO readings completed', 'timeFrame': '12 weeks', 'description': 'Feasibility of study determined by number of CO readings completed by each participant'}], 'secondaryOutcomes': [{'measure': 'Quit outcomes', 'timeFrame': '12 weeks', 'description': 'Proportion of participants who quit smoking'}, {'measure': 'Cigarettes per day', 'timeFrame': '12 weeks', 'description': 'Reduction in cigarettes smoked per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32537238', 'type': 'DERIVED', 'citation': 'Martinez SA, Quaife SL, Hasan A, McMillan KA, Beebe LA, Muirhead F. Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial. Pilot Feasibility Stud. 2020 Jun 11;6:82. doi: 10.1186/s40814-020-00629-7. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered.', 'detailedDescription': 'Individuals with type 2 diabetes (T2D) are at an increased risk of many cancers, though the causal link is not well understood. Continuing to smoke after a T2D diagnosis is also associated with accelerated progression of microvascular and macrovascular complications and an increased risk of death. Smoking cessation is recommended as a standard treatment for diabetes. However, both patients and providers are faced with other challenging lifestyle changes and disease management processes, which lead to greater difficulty in quitting.\n\nContingency management, or a method of providing financial incentives contingent upon positive behaviors, has shown promise for improving adherence to medication among diabetics and for improving smoking cessation in other populations. This approach could offer an innovative and scalable means of increasing abstinence in this group, ultimately reducing their risk of cancer. This is a multicenter pilot randomized controlled trial that will recruit participants in Oklahoma and in Strathclyde, Scotland.\n\nThis pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered. Qualitative semi-structured interviews will be used to explore the patient and provider acceptability of an incentive-based cessation program, any unintended consequences and possible differences between UK and US health settings.\n\nThe results of this research will inform the feasibility of carrying out a randomized controlled trial of this intervention. The ultimate aim is to develop an effective intervention that could be scaled to the T2D population at large, which reduces cancer risk and improves disease outcomes among a high-risk group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 75\n* Type 2 diabetes diagnosis greater than 1 year prior to enrollment\n* Currently smoking at least 5 cigarettes per day\n* Self-reported quit attempt in past 12 months\n\nExclusion Criteria:\n\n* Unwilling to make a quit attempt\n* Unable to use smartphone iCO monitor following training session'}, 'identificationModule': {'nctId': 'NCT03527667', 'briefTitle': 'Incentivized Smoking Cessation for Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Incentivized Smoking Cessation for Tobacco Treatment-Resistant Diabetics', 'orgStudyIdInfo': {'id': '8652'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short term incentives', 'description': 'usual quit smoking treatment (counseling + medication) plus 6-weeks of payments for proof of smoking abstinence', 'interventionNames': ['Behavioral: Financial incentives']}, {'type': 'EXPERIMENTAL', 'label': 'Long term incentives', 'description': 'usual quit smoking treatment (counseling + medication) plus 12-weeks of payments for proof of smoking abstinence', 'interventionNames': ['Behavioral: Financial incentives']}, {'type': 'NO_INTERVENTION', 'label': 'No incentives', 'description': 'usual quit smoking treatment (counseling + medication)'}], 'interventions': [{'name': 'Financial incentives', 'type': 'BEHAVIORAL', 'description': 'Treatment arm participants will receive financial incentives ($20 per week) contingent on biochemically verified smoking abstinence submitted once daily for the time period allocated.', 'armGroupLabels': ['Long term incentives', 'Short term incentives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University of Strathclyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Sydney A Martinez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}, {'name': 'University of Strathclyde', 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}