Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT05881304
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2023-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cigarettes smoked per day', 'timeFrame': 'Baseline 2 to 8 weeks', 'description': 'Change in cigarettes smoked per day (CPD) between randomized groups. Change in mean number of CPD in the past 7 days from Baseline 2 to Week 8 comparing between randomized groups (iSREC group vs. WLC).'}], 'secondaryOutcomes': [{'measure': 'Study enrollment', 'timeFrame': 'Baseline', 'description': 'Proportion of those screened identified as eligible. Proportion of those identified as eligible at screening who enroll in trial.'}, {'measure': 'E-cigarette use during e-cigarette provision', 'timeFrame': 'During the 8 weeks of e-cigarette provision', 'description': 'Mean days of e-cigarette use in past 7 days. 1) Number of days of e-cigarette use in past 7 days at Weeks 2, 4, 6, and 8 between randomized groups, and 2) number of days of e-cigarette use in the past 7 days in a pre-post analysis that combines randomized groups'}, {'measure': 'Breath carbon monoxide', 'timeFrame': 'Baseline 1-Week 8', 'description': 'Change in expired air carbon monoxide (CO)- during e-cigarette provision. Change in expired air CO (ppm) from Baseline to Week 8 between randomized groups.'}, {'measure': 'Anabasine', 'timeFrame': 'Baseline 1-Week 8', 'description': 'Change in anabasine - during e-cigarette provision. Change in urine anabasine level (ng/ml)from Baseline 1 to Week 8 between randomized groups.'}, {'measure': 'Study completion', 'timeFrame': 'Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC)', 'description': 'Proportion of patients who complete the trial, defined as completing the final follow-up assessment (12 weeks for iSREC and 20 weeks for WLC) and \\>=50% of the study visits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electronic Cigarette Use']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day \\[primary outcome\\], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control \\[WLC\\]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n\n * Report daily cigarette smoking (\\>=10 cigarettes per day in the past week)\n * Not ready to quit smoking (not planning to quit in the next 30 days)\n * Willing to try e-cigarettes\n * In stable buprenorphine (BUP) treatment for opioid use disorder at an Massachusetts General Hospital-affiliated primary care clinic (in treatment for \\>=3 months without changes in BUP dose in the past 2 weeks and planning to remain on current BUP treatment for \\>=3 months).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (\\>3 days in past 30 days)\n* Report past 30-day use of behavioral or pharmacologic smoking cessation aids\n* Deemed inappropriate for participation by their OUD provider\n* Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy \\<1 year).'}, 'identificationModule': {'nctId': 'NCT05881304', 'acronym': 'SWITCHED', 'briefTitle': 'Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC', 'orgStudyIdInfo': {'id': '2023p001364'}, 'secondaryIdInfos': [{'id': 'K23DA056583', 'link': 'https://reporter.nih.gov/quickSearch/K23DA056583', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate SREC provision (iSREC)', 'description': 'Those randomized to the iSREC group will be provided a free 8-week supply of standardized research e-cigarettes (SRECs) and asked to try to switch completely to the SREC.', 'interventionNames': ['Device: Standardized research e-cigarette (SREC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed SREC provision waitlist control (WLC)', 'description': 'Those in the WLC condition will receive SREC provision after an 8-week delay.', 'interventionNames': ['Device: Standardized research e-cigarette (SREC)']}], 'interventions': [{'name': 'Standardized research e-cigarette (SREC)', 'type': 'DEVICE', 'otherNames': ['SREC'], 'description': "Patients will be provided with NIDA's standardized research electronic cigarette (SREC) for 8-weeks and asked to attempt to substitute the SREC for combusted cigarettes during the 8 weeks. Participants will be randomized in a 1:1 ratio to 1 of 2 conditions for 8 weeks: 1) immediate standardized research e-cigarette provision (iSREC) or 2) delayed SREC provision waitlist control (WLC). Those randomized to the iSREC group will be provided a free 8-week supply of SRECs and asked to try to switch completely to the SREC. Those in the WLC condition will receive SREC provision after an 8-week delay.", 'armGroupLabels': ['Delayed SREC provision waitlist control (WLC)', 'Immediate SREC provision (iSREC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanna M Streck, PhD', 'role': 'CONTACT', 'email': 'jstreck@mgh.harvard.edu', 'phone': '617-643-9977'}, {'name': 'Michele Reyen, MPH', 'role': 'CONTACT', 'email': 'mreyen@mgh.harvard.edu'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Joanna M Streck, PhD', 'role': 'CONTACT', 'email': 'jstreck@mgh.harvard.edu', 'phone': '617-643-9977'}], 'overallOfficials': [{'name': 'Joanna M Streck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Psychiatry', 'investigatorFullName': 'Joanna M. Streck, Ph.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}