Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-01 @ 3:50 PM
Study NCT ID:
NCT04843969
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2021-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Cigarette Cravings in Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-11', 'studyFirstSubmitDate': '2021-04-03', 'studyFirstSubmitQcDate': '2021-04-11', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3', 'timeFrame': 'Multiple time points during the intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention', 'description': 'Participants will be asked to complete a mood questionnaire at several time points during the intervention and at test sessions 1, 2 and 3'}, {'measure': 'Change in cigarette use over the course of the procedure as a function of personality factors, childhood trauma, perceived stress, mood and/or cigarette withdrawal', 'timeFrame': 'Multiple time points at baseline, during the intervention, at test sessions (24 hours, 2 weeks and 6 weeks post-intervention) and telephone follow-ups (6 months post-intervention)', 'description': 'Participants will be asked to complete self-report questionnaires about their personality traits, traumatic childhood experiences, perceived stress, current mood states and cigarette withdrawal symptoms'}], 'primaryOutcomes': [{'measure': 'Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention', 'timeFrame': 'At the end of test session 1 (24 hours post-intervention), participants will receive a journal to record their daily smoking behaviour. They are asked to keep this journal until test session 3 (6 weeks post-intervention).', 'description': 'A journal is given to participants to record their cigarette use behaviour every day for a month and a half'}], 'secondaryOutcomes': [{'measure': 'Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2', 'timeFrame': 'Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.', 'description': 'Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions'}, {'measure': 'Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 3', 'timeFrame': 'Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.', 'description': 'Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions'}, {'measure': 'Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 2', 'timeFrame': 'Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention', 'description': "Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions"}, {'measure': 'Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 3', 'timeFrame': 'Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention', 'description': "Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions"}, {'measure': 'Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 2', 'timeFrame': 'Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention', 'description': "Participants' skin conductance will be measured through the use of electrodes on their index and middle fingers at several time points during the study sessions"}, {'measure': 'Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 3', 'timeFrame': 'Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention', 'description': "Participants' skin conductance will be measured through the use of electrodes on their index and middle fingers at several time points during the study sessions"}, {'measure': 'Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to during COVID-19', 'timeFrame': 'Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic', 'description': 'Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently'}, {'measure': 'Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to post-COVID-19', 'timeFrame': 'At baseline (before the pandemic) and through study completion, an average of 1 year', 'description': 'Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently'}, {'measure': 'Change in tobacco and other substance use patterns during the COVID-19 pandemic to post-COVID-19', 'timeFrame': 'Multiple time points during the pandemic and through study completion, an average of 1 year', 'description': 'Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Memory updating', 'Reconsolidation'], 'conditions': ['Cigarette Smoking', 'Addiction Nicotine', 'Tobacco Use']}, 'referencesModule': {'references': [{'pmid': '36175551', 'type': 'DERIVED', 'citation': 'Barnabe A, Gamache K, de Camargo JVP, Allen-Flanagan E, Rioux M, Pruessner J, Leyton M, Nader K. A novel stress-based intervention reduces cigarette use in non-treatment seeking smokers. Neuropsychopharmacology. 2023 Jan;48(2):308-316. doi: 10.1038/s41386-022-01455-6. Epub 2022 Sep 29.'}]}, 'descriptionModule': {'briefSummary': "Interventions to disrupt memory reconsolidation have held promise for the treatment of stress- and anxiety-related disorders. In the present study, the investigators will examine whether an intervention based on these principles, called memory updating, could be adapted for reward-seeking behaviors. To test this, non-treatment seeking tobacco smokers will be exposed to smoking cues and/or stress, two stimuli known to trigger smoking. It is predicted that exposure to a stress task will enhance the cues' motivational salience and yield greater susceptibility to the memory updating procedure.\n\nAs an add-on, the investigators will examine COVID-associated changes in substance use and whether participants in the memory updating groups might be more resilient to these effects. It is predicted that the changes in substance use will depend on whether the substances are used primarily in social settings.", 'detailedDescription': 'Non-treatment seeking cigarette dependent smokers will be randomized to one of four testing conditions: 1) a non-stressful task followed by neutral cues, 2) the non-stressful task followed by smoking cues, 3) a stressful task followed by neutral cues, or 4) the stressful task followed by smoking cues. Ten minutes after the intervention, participants will undergo a 60-minute extinction procedure consisting of smoking-related videos, images and smoking paraphernalia. Cue reactivity test sessions will take place 24 hours, 2 weeks and 6 weeks following the intervention.\n\nCOVID-associated changes in substance use will be quantified over three telephone interviews: one at the end of March / beginning of April 2020 (at the start of the pandemic), one at the end of April / beginning of May, and a final one which will be instituted if feasible once the infection rates and social distancing policies have decreased.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scoring 5 or higher on the Fagerström Test for Cigarette Dependence\n* Willingness to abstain from smoking for 4 hours prior to each laboratory visit\n\nExclusion Criteria:\n\n* Currently using cigarette cessation products\n* Endocrinological problems\n* Significant mental or physical health conditions\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04843969', 'briefTitle': 'Investigation of Cigarette Cravings in Smokers', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers', 'orgStudyIdInfo': {'id': '421-0318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress task and smoking cue', 'description': 'Exposure to a psychosocial stress task followed by smoking video cues', 'interventionNames': ['Behavioral: Stress induction', 'Behavioral: Cue induction']}, {'type': 'EXPERIMENTAL', 'label': 'Stress task and neutral cue', 'description': 'Exposure to a psychosocial stress task followed by neutral video cues', 'interventionNames': ['Behavioral: Stress induction', 'Behavioral: Neutral cue exposure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control task and smoking cue', 'description': 'Exposure to a control task followed by smoking video cues', 'interventionNames': ['Behavioral: Control stress exposure', 'Behavioral: Cue induction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control task and neutral cue', 'description': 'Exposure to a control task followed by neutral video cues', 'interventionNames': ['Behavioral: Control stress exposure', 'Behavioral: Neutral cue exposure']}], 'interventions': [{'name': 'Stress induction', 'type': 'BEHAVIORAL', 'description': 'Exposure to a psychosocial stressor', 'armGroupLabels': ['Stress task and neutral cue', 'Stress task and smoking cue']}, {'name': 'Control stress exposure', 'type': 'BEHAVIORAL', 'description': 'Exposure to a control task (no stress)', 'armGroupLabels': ['Control task and neutral cue', 'Control task and smoking cue']}, {'name': 'Cue induction', 'type': 'BEHAVIORAL', 'description': 'Exposure to a smoking-related task', 'armGroupLabels': ['Control task and smoking cue', 'Stress task and smoking cue']}, {'name': 'Neutral cue exposure', 'type': 'BEHAVIORAL', 'description': 'Exposure to neutral cues', 'armGroupLabels': ['Control task and neutral cue', 'Stress task and neutral cue']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Marco Leyton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'From 9 to 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'We will share deidentified individual participant data that underlie any results reported in the article. This includes results reported in text, figures and appendices.', 'accessCriteria': 'Investigators whose proposed use of the data has already been approved by an ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marco Leyton', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marco Leyton', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}