Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 2:22 AM
Study NCT ID:
NCT06556433
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2024-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-Based Financial Incentives Intervention for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1312}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in smoking status', 'timeFrame': '6 months, 12 months', 'description': 'Number of participants to have biochemically verified, prolonged smoking abstinence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alaska Native', 'Family', 'Financial Incentive', 'Smoking Cessation', 'Contingency Management'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '37091507', 'type': 'BACKGROUND', 'citation': 'Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.'}, {'pmid': '38642396', 'type': 'BACKGROUND', 'citation': 'Sinicrope PS, Tranby BN, Young AM, Koller KR, King DK, Lee FR, Sabaque CV, Prochaska JJ, Borah BJ, Decker PA, McDonell MG, Stillwater B, Thomas TK, Patten CA. Adapting a Financial Incentives Intervention for Smoking Cessation With Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study. Nicotine Tob Res. 2024 Sep 23;26(10):1377-1384. doi: 10.1093/ntr/ntae092.'}]}, 'descriptionModule': {'briefSummary': 'The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.', 'detailedDescription': "Dyads will be stratified by the index participant's sex, and residence with family member, and by the family member's current smoking status then randomized to a no incentives control condition (n=328 dyads) or a 6-month incentive intervention (n=328 dyads).\n\nAll dyads will receive existing evidence-based cessation materials on treatment resources and social support strategies. The study will measure the index participant's smoking status in both study groups weekly during the first four weeks, and at three and six months. All participants, including support persons, will receive incentives when they complete each of the smoking status assessments. The intervention group will additionally receive individual rewards provided to the index participant for achieving verified smoking abstinence at each time point, to a maximum of $750.\n\nThe enrolled family member will also receive rewards equivalent to the value earned by the index participant that can contribute to family needs. The study will explore potential moderators (e.g., family member smoking status, index participant's sex) and mediators (e.g., interdependence) of intervention effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Index Participant Inclusion Criteria:\n\n* Alaska Native/American Indian (ANAI) person (based on self-reported race) and reside in Alaska.\n* Age ≥18 years.\n* Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng/mL (positive result based on at-home saliva swab test provided by study team).\n* Smoked ≥ 3 cigarettes per day over the past 3 months.\n* Considering or willing to make a quit attempt.\n* Have or will nominate one adult family member to enroll with them.\n* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration\n* Willing to upload photos of self during completion of smoking status tests.\n* Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.\n* Willing to provide written informed consent and participate in study-related tests and procedures.\n\nIndex Participant Exclusion Criteria:\n\n* Used pharmacotherapy or a stop smoking program within the past 3 months.\n* Already enrolled in the study with another family member.\n* Self-report current marijuana smoking more than once per week and are not willing to quit for the study duration (interferes with breath test).\n* Participated in a prior study phase.\n\nFamily Member Participant Inclusion Criteria (regardless of smoking status or residence with the index participant):\n\n* Age ≥18 years.\n* Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.\n* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.\n* Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.\n* Willing to provide written informed consent and participate in study related tests and procedures.\n\nBoth men and women, those from non-ANAI racial/ethnic groups, and those who live outside of Alaska in the United States will be eligible family member participants.\n\nFamily Member Participant Exclusion Criteria:\n\n* Already enrolled with another family member.\n* Participated in a prior study phase.\n\nAfter the randomized controlled trial, qualitative interviews will be conducted with index participants, family member participants, and Alaska Tribal Health System Stakeholders to inform program implementation. Healthcare providers, cessation specialists, Elder advisors, and Tribal Health System leaders and stakeholders will be invited by the Alaska Native Tribal Health Consortium team and separately consented and interviewed.'}, 'identificationModule': {'nctId': 'NCT06556433', 'acronym': 'Aniqsaaq-RCT', 'briefTitle': 'Family-Based Financial Incentives Intervention for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation: An RCT', 'orgStudyIdInfo': {'id': '2024-04-015'}, 'secondaryIdInfos': [{'id': '1R01DA056469-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA056469-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rewards Group', 'description': 'Index participants in the Rewards Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Rewards Group will receive informational materials on smoking cessation.', 'interventionNames': ['Behavioral: Financial Incentive Rewards']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison Group', 'description': 'Index participants in the Comparison Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Comparison Group will receive informational materials on smoking cessation.'}], 'interventions': [{'name': 'Financial Incentive Rewards', 'type': 'BEHAVIORAL', 'description': 'Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.', 'armGroupLabels': ['Rewards Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timothy K Thomas, MD', 'role': 'CONTACT', 'email': 'tkthomas@anthc.org', 'phone': '907-729-1900'}, {'name': 'Barb J Stillwater, PhD', 'role': 'CONTACT', 'email': 'bjstillwater@anthc.org', 'phone': '1-907-729-1900'}], 'facility': 'Alaska Native Tribal Health Consortium', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}], 'centralContacts': [{'name': 'Christi A Patten, PhD', 'role': 'CONTACT', 'email': 'patten.christi@mayo.edu', 'phone': '507-261-0718'}, {'name': 'Audrey G McGuinness, BA', 'role': 'CONTACT', 'email': 'McGuinness.Audrey@mayo.edu', 'phone': '1-507-422-5074'}], 'overallOfficials': [{'name': 'Christi A Patten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Alaska Native Tribal Health Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Behavioral Health Research Program', 'investigatorFullName': 'Christi Patten', 'investigatorAffiliation': 'Mayo Clinic'}}}}