Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-02 @ 2:12 AM
Study NCT ID:
NCT04297332
Status:
TERMINATED
Last Update Posted:
2024-02-08
First Post:
2020-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Episodic Future Thinking and Future Thinking Priming for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Delay discounting rate', 'timeFrame': 'Baseline, and 4 and 12 weeks after quit date', 'description': 'Assessed with the 5-Trial Adjusting Delay Discounting.'}, {'measure': 'Latency to relapse', 'timeFrame': 'Baseline, assessed up to 12 weeks', 'description': 'Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.'}], 'secondaryOutcomes': [{'measure': 'Latency to first relapse', 'timeFrame': 'up to 12 weeks', 'description': 'Defined as the number of days until first relapse (any smoking for seven consecutive days). Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.'}, {'measure': 'Number of days abstinent', 'timeFrame': 'Up to 12 weeks', 'description': 'Will be evaluated by cox proportional-hazards survival model analyses.'}, {'measure': '7-day point prevalence abstinence rates', 'timeFrame': 'At 4 and 12 weeks after quit date', 'description': 'Will be evaluated by cox proportional-hazards survival model analyses.'}, {'measure': 'Attentional, motor, and non-planning impulsiveness', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessed with the Barratt Impulsiveness Scale.'}, {'measure': 'Behavioral inhibition and behavioral activation', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessed with the Behavioral Avoidance/Inhibition scales.'}, {'measure': 'Self-control', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessed with the Brief Self-Control Survey.'}, {'measure': 'Ability to regulate behavior to achieve goals', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessed with the Short Self-Regulation Questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco-Related Carcinoma']}, 'descriptionModule': {'briefSummary': 'This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To quantify the main and interactive effects of the episodic future thinking (EFT) and future thinking priming (FTP) tasks on delay discounting rate, latency to relapse, and multiple abstinence and self-regulation measures among smokers (n=76) who call a busy Quitline to quit smoking.\n\nOUTLINE: Participants are randomized to 1 of 4 arms.\n\nARM I: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.\n\nARM II: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.\n\nARM III: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.\n\nARM IV: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoke \\>= 8 cigarettes daily\n* Planning to quit in the next 14 days\n* No regular use of other tobacco products\n* Access to the internet\n* In possession of a smartphone with text messaging capabilities\n* In possession of an email address accessible at least every other day\n\nExclusion Criteria:\n\n* Unable or unwilling to provide consent\n* Unable to provide data to the research team after the quit date\n* Current use of bupropion or varenicline\n* Drinking \\>= 20 alcoholic drinks per week\n* Use of drugs of abuse in the past 30 days\n* Living in the same household as a participant already enrolled in this study'}, 'identificationModule': {'nctId': 'NCT04297332', 'briefTitle': 'Episodic Future Thinking and Future Thinking Priming for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Promising Methods to Decrease Delay Discounting and Reduce Relapse to Smoking', 'orgStudyIdInfo': {'id': 'I 82819'}, 'secondaryIdInfos': [{'id': 'NCI-2020-00697', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 82819', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (active EFT, active FTP)', 'description': 'Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Informational Intervention', 'Other: Telephone-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (active EFT, control FTP)', 'description': 'Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Informational Intervention', 'Drug: Nicotine Replacement', 'Other: Telephone-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (control EFT, active FTP)', 'description': 'Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Informational Intervention', 'Drug: Nicotine Replacement', 'Other: Telephone-Based Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm IV (control EFT, control TFP)', 'description': 'Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Informational Intervention', 'Drug: Nicotine Replacement', 'Other: Telephone-Based Intervention']}], 'interventions': [{'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'behavior modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Interventions', 'Behavioral Modification', 'BEHAVIORAL THERAPY', 'Behavioral Treatment', 'Behavioral Treatments'], 'description': 'Complete active episodic thinking task', 'armGroupLabels': ['Arm I (active EFT, active FTP)', 'Arm II (active EFT, control FTP)']}, {'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'behavior modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Interventions', 'Behavioral Modification', 'BEHAVIORAL THERAPY', 'Behavioral Treatment', 'Behavioral Treatments'], 'description': 'Complete active future thinking priming task', 'armGroupLabels': ['Arm I (active EFT, active FTP)', 'Arm III (control EFT, active FTP)']}, {'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'behavior modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Interventions', 'Behavioral Modification', 'BEHAVIORAL THERAPY', 'Behavioral Treatment', 'Behavioral Treatments'], 'description': 'Complete control episodic future thinking task', 'armGroupLabels': ['Arm III (control EFT, active FTP)', 'Arm IV (control EFT, control TFP)']}, {'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'behavior modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Interventions', 'Behavioral Modification', 'BEHAVIORAL THERAPY', 'Behavioral Treatment', 'Behavioral Treatments'], 'description': 'Complete control future thinking priming task', 'armGroupLabels': ['Arm II (active EFT, control FTP)', 'Arm IV (control EFT, control TFP)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Provided with Forever Free relapse prevention booklet', 'armGroupLabels': ['Arm I (active EFT, active FTP)', 'Arm II (active EFT, control FTP)', 'Arm III (control EFT, active FTP)', 'Arm IV (control EFT, control TFP)']}, {'name': 'Nicotine Replacement', 'type': 'DRUG', 'otherNames': ['nicotine replacement therapy', 'NRT'], 'description': 'Receive nicotine patches, gum, or lozenges', 'armGroupLabels': ['Arm II (active EFT, control FTP)', 'Arm III (control EFT, active FTP)', 'Arm IV (control EFT, control TFP)']}, {'name': 'Telephone-Based Intervention', 'type': 'OTHER', 'description': 'Receive coaching call', 'armGroupLabels': ['Arm I (active EFT, active FTP)', 'Arm II (active EFT, control FTP)', 'Arm III (control EFT, active FTP)', 'Arm IV (control EFT, control TFP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Christine Sheffer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}