Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05306158
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual Use Approach Bias Training for Nicotine Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'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', 'interventionModelDescription': 'There are three arms, one intervention (CC+ECIG Condition), one active comparator (CC Condition), and one Sham (control) arm which are randomly assigned at the same time (baseline) and are implemented in parallel.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically-Verified Point Prevalence Abstinence', 'timeFrame': 'Week 9 of participation', 'description': 'Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)'}, {'measure': 'Prolonged Abstinence', 'timeFrame': 'Week 9 of participation', 'description': 'Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)'}, {'measure': 'Lapse', 'timeFrame': 'Week 9 of participation', 'description': 'Time to first use (CC and/or ECIG)'}, {'measure': 'Nicotine Relapse', 'timeFrame': 'Week 9 of participation', 'description': '7th day on which CC or ECIG occurs'}], 'secondaryOutcomes': [{'measure': 'Questionnaire of Smoking Urges-Brief (QSU-Brief)', 'timeFrame': 'Week 1-7, 9, and 11 of participation', 'description': "The Brief Questionnaire of Smoking Urges (QSU-Brief) consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now)."}, {'measure': 'Questionnaire of Vaping Craving', 'timeFrame': 'Week 1-7, 9, and 11 of participation', 'description': "The Questionnaire of Vaping Craving is a modified measure of the QSU and consists of 10 statements about the respondent's feelings and thoughts about his or her desire to vape as he or she is completing the questionnaire (i.e., right now)."}, {'measure': 'Approach Bias', 'timeFrame': 'Weeks 2-5 of participation', 'description': 'The approach-avoidance task (AAT) is a 15-minute computerized task instructs participants to use a joystick to either pull toward themselves or push away from themselves images presented on the screen that vary in content (i.e., substance-related, neutral, positive) and format (e.g., right- or left-tilted).'}, {'measure': 'Biochemically-Verified Point Prevalence Abstinence', 'timeFrame': 'Week 11 of participation', 'description': 'Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)'}, {'measure': 'Prolonged Abstinence', 'timeFrame': 'Week 11 of participation', 'description': 'Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)'}, {'measure': 'Lapse', 'timeFrame': 'Week 11 of participation', 'description': 'Time to first use (CC and/or ECIG)'}, {'measure': 'Nicotine Relapse', 'timeFrame': 'Week 11 of participation', 'description': '7th day on which CC or ECIG occurs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Smoking', 'Electronic Cigarette Use', 'Substance Use']}, 'referencesModule': {'references': [{'pmid': '36905980', 'type': 'DERIVED', 'citation': 'Clausen B, Rinck M, Nizio P, Matoska CT, Zappi C, Smits JAJ, Gallagher MW, Zvolensky MJ, Garey L. Study protocol for approach bias retraining for nicotine addiction among dual combustible and electronic cigarette users. Contemp Clin Trials. 2023 May;128:107145. doi: 10.1016/j.cct.2023.107145. Epub 2023 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.', 'detailedDescription': 'The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* At least 15 days of CC use for the previous month\n* ECIG use with nicotine at least 15 days for the previous month\n* Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)\n* Ability to speak and read English fluently\n* Not have decreased number of cigarettes by more than half in the past month\n* Own an android smartphone (for EMA).\n\nExclusion Criteria:\n\n* Current psychotherapy or pharmacotherapy for mental illness or addiction\n* Current use of nicotine replacement therapy, Zyban, or Chantix\n* Limited mental capacity or inability to provide informed consent\n* Insufficient command of the English language (\\>6th grade English literacy level required)'}, 'identificationModule': {'nctId': 'NCT05306158', 'briefTitle': 'Dual Use Approach Bias Training for Nicotine Addiction', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users', 'orgStudyIdInfo': {'id': 'PAR-19-309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC+ECIG Condition', 'description': 'Combustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images.', 'interventionNames': ['Other: CC+ECIG Condition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CC Only Condition', 'description': 'Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images.', 'interventionNames': ['Other: CC Condition']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Condition', 'description': 'Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other.', 'interventionNames': ['Other: Sham Condition']}], 'interventions': [{'name': 'CC+ECIG Condition', 'type': 'OTHER', 'description': 'Participants will push CC- and ECIG-related pictures.', 'armGroupLabels': ['CC+ECIG Condition']}, {'name': 'CC Condition', 'type': 'OTHER', 'description': 'Participants will push CC-related images and push and pull ECIG-related pictures equally often.', 'armGroupLabels': ['CC Only Condition']}, {'name': 'Sham Condition', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Participants will pull and push CC- and ECIG-related pictures equally often.', 'armGroupLabels': ['Sham Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'RESTORE Laboratory', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lorra Garey, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Research Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'One year after completion upon request.', 'ipdSharing': 'YES', 'description': "We will provide de-identified data from this project to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome paper). These data will be provided in digital format (i.e., disk) with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.", 'accessCriteria': 'Upon specific IRB approval and request from researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Professor', 'investigatorFullName': 'Lorra Garey', 'investigatorAffiliation': 'University of Houston'}}}}