Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-06 @ 2:02 AM
Study NCT ID:
NCT06609369
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants who smoke randomly assigned and stratified by sex and severity of tobacco dependence'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number cigarettes smoked per day', 'timeFrame': 'Baseline, week 4, 8, 12, and 26', 'description': 'Mean number cigarettes smoked per day assessed by Time Line Follow Back method'}, {'measure': 'Smoking status', 'timeFrame': 'Baseline', 'description': 'Assess expired breath carbon monoxide (CO) at baseline. CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO \\<5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels).'}, {'measure': 'Quit status', 'timeFrame': 'Week 4, 8, 12, and 26', 'description': 'To inquire whether participants have refrained from tobacco use at each visit following their quit date. The quit status will also be verified by assessing expired breath carbon monoxide (CO). CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO \\<5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels)'}, {'measure': 'Days to smoking relapse', 'timeFrame': 'Week 4, 8, 12, and 26', 'description': 'Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back'}], 'secondaryOutcomes': [{'measure': 'Change in PROMIS Sleep Disturbance', 'timeFrame': 'Baseline, week 4, 8, 12, and 26', 'description': 'The PROMIS Sleep Disturbance is an 8 item self-report of perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each item on the measure is rated on a 5-point scale. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. High scores mean greater severity of sleep disturbance.'}, {'measure': 'Change in PROMIS Sleep-Related Impairment', 'timeFrame': 'Baseline, week 4, 8, 12, and 26', 'description': 'The PROMIS Sleep-Related Impairment is an 8 item self-report of perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness. Each item on the measure is rated on a 4-point scale. The score range is 4 to 32. High scores mean greater severity of sleep related impairment.'}, {'measure': 'Change in Insomnia Severity Index', 'timeFrame': 'Baseline, week 4, 8, 12, and 26', 'description': 'The Insomnia Severity Index is a 7-item brief screening tool for insomnia. Each item on the measure is rated on a 5-point scale (0-4), with a total score range 0-28. High scores mean greater severity of insomnia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use', 'Tobacco Cessation', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.', 'detailedDescription': 'The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.\n\nInvestigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.\n\nAll participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.\n\nParticipants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English literate\n* report heavy tobacco use (including nicotine e-cigarettes) for \\>6 months\n* meet biochemical cut off for recent cigarette smoking or e-cigarette use\n* optimal body mass index\n\nExclusion Criteria:\n\n* currently enrolled in other treatments\n* neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep\n* medical contraindications for fMRI, varenicline, and/or behavioral treatment\n* factors that cause deficient sleep and for which behavioral treatment has less benefit\n* women who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT06609369', 'briefTitle': 'Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse', 'orgStudyIdInfo': {'id': '2000037737'}, 'secondaryIdInfos': [{'id': 'R01DA061285', 'link': 'https://reporter.nih.gov/quickSearch/R01DA061285', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental health intervention', 'description': 'Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks', 'interventionNames': ['Behavioral: Experimental health intervention', 'Drug: Varenicline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control health intervention', 'description': 'Control health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks', 'interventionNames': ['Drug: Varenicline']}], 'interventions': [{'name': 'Experimental health intervention', 'type': 'BEHAVIORAL', 'description': 'Behavioral health intervention', 'armGroupLabels': ['Experimental health intervention']}, {'name': 'Varenicline', 'type': 'DRUG', 'description': 'Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.', 'armGroupLabels': ['Control health intervention', 'Experimental health intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yu Chen, PhD', 'role': 'CONTACT', 'email': 'sleepstudy@yale.edu', 'phone': '475-261-6153'}], 'facility': 'Connecticut Mental Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yu Chen, PhD', 'role': 'CONTACT', 'email': 'sleepstudy@yale.edu', 'phone': '475-261-6153'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Yu Chen, PhD', 'role': 'CONTACT', 'email': 'yu.chen.yc838@yale.edu', 'phone': '347-819-2969'}, {'name': 'Lisa Fucito, PhD', 'role': 'CONTACT', 'email': 'lisa.fucito@yale.edu', 'phone': '203-200-1470'}], 'overallOfficials': [{'name': 'Chiang-Shan Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Lisa Fucito, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}