Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06208202
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceptions of E-Cigarettes and Synthetic Cooling Agents, the ICE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and study staff will be blinded to the study conditions delivered at each visit.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator. Participants and data collection staff will be blinded to the order/conditions administered at each trial. The sequence list and subsequent participant ID numbers will be kept separate from data collection staff and will only be accessible by staff who will not be interacting with participants.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction and psychological reward', 'timeFrame': 'Minute 5 of vaping session, Minute 35 of vaping session', 'description': 'Satisfaction and psychological reward of e-cigarette (EC) vaping will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ asks questions relating to satisfaction of using e-cigarettes on a scale from 0 (Not at all) - 6 (Extremely).'}, {'measure': 'Sensory perceptions of EC vaping experience', 'timeFrame': 'Pre-vaping session', 'description': 'Sensory perceptions of EC vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).'}, {'measure': 'E-cigarette puff topography', 'timeFrame': '35 Minute Vaping session', 'description': 'Will be measured with a topography device that records frequency, duration, and flow rate of EC puffs. These measures are combined to inform overall EC puff behavior.'}, {'measure': 'Levels of HPHC and other toxicant exposure from vaping e-liquids', 'timeFrame': 'After completion of sessions, estimated 4 years', 'description': 'Topography data collected for all participants for each of the conditions vaped will be averaged to produce four human-derived puffing regimens. Machine vaping will be conducted for each of the four e-liquids using the associated human-derived puffing regimens to determine the range of HPHCs and other toxicants in mainstream EC vapor.'}, {'measure': 'Appeal and Sensory', 'timeFrame': 'Minute 5 of vaping session, Minute 35 of vaping session', 'description': 'Participants will rate appeal (e.g., liking, disliking) and sensory attributes (e.g., harshness, coolness) outcomes on Visual Analogue Scales (range, 0-100).'}], 'secondaryOutcomes': [{'measure': 'Economic demand breakpoint', 'timeFrame': 'Minute 35 of vaping session', 'description': 'The price point at which a participant is no longer willing to pay for a puff of the study e-liquid will be determined by an EC purchase task questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abuse Tobacco', 'Exposure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Assess the abuse liability of e-liquids with and without the presence of synthetic cooling agents.\n\nII. Determine the impact of synthetic cooling agents and flavor on EC puffing behavior (topography).\n\nIII. Determine the exposure ranges (harmful and potentially harmful constituents \\[HPHCs\\], other toxicants) from vaping e-liquids with and without the presence of synthetic cooling agents.\n\nOUTLINE:\n\nParticipants attend 4 sessions where they receive 1 of 4 randomly assigned flavored e-cigarettes. Participants use the e cigarettes for vaping followed by ad libitum vaping. Participants also complete surveys and undergo biosample collection throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21-29 years\n* Current exclusive e-cigarette (EC) user (defined as ≥ weekly use over the past 3 months)\n* Willing to provide informed consent and abstain from using their EC at least 12 hours prior to the four lab sessions\n* Read and speak English\n\nExclusion Criteria:\n\n* Recently COVID-19+ (defined as positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months)\n* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)\n* History of cardiac event or distress within the past 3 months\n* Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)\n* Have suffered from any serious lung disease or infection (e.g. , tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days\n* Have hemophilia or another type of bleeding disorder\n* Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability'}, 'identificationModule': {'nctId': 'NCT06208202', 'acronym': 'ICE', 'briefTitle': 'Perceptions of E-Cigarettes and Synthetic Cooling Agents, the ICE Study', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'The ICE Study: Perceptions of E-Cigarettes and Synthetic Cooling Agents (R01)', 'orgStudyIdInfo': {'id': 'OSU-23040'}, 'secondaryIdInfos': [{'id': 'NCI-2023-06312', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'R01CA276696', 'link': 'https://reporter.nih.gov/quickSearch/R01CA276696', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fruit flavored e-cigarette with synthetic cooling agents added', 'description': 'Synthetic cooling agents will be added to fruit flavored e-liquid for this condition.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Biospecimen Collection', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fruit flavored e-cigarette', 'description': 'Fruit flavored e-liquid will be used for this condition.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Biospecimen Collection', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobacco flavored e-cigarette with synthetic cooling agents added', 'description': 'Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Biospecimen Collection', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobacco flavored e-cigarette', 'description': 'Tobacco flavored e-liquid will be used for this condition.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Biospecimen Collection', 'Other: Survey Administration']}], 'interventions': [{'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive and use flavored e-cigarettes (EC) as directed', 'armGroupLabels': ['Fruit flavored e-cigarette', 'Fruit flavored e-cigarette with synthetic cooling agents added', 'Tobacco flavored e-cigarette', 'Tobacco flavored e-cigarette with synthetic cooling agents added']}, {'name': 'Biospecimen Collection', 'type': 'OTHER', 'otherNames': ['Biological Sample Collection', 'Specimen Collection'], 'description': 'Undergo biosample sample collection', 'armGroupLabels': ['Fruit flavored e-cigarette', 'Fruit flavored e-cigarette with synthetic cooling agents added', 'Tobacco flavored e-cigarette', 'Tobacco flavored e-cigarette with synthetic cooling agents added']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete surveys', 'armGroupLabels': ['Fruit flavored e-cigarette', 'Fruit flavored e-cigarette with synthetic cooling agents added', 'Tobacco flavored e-cigarette', 'Tobacco flavored e-cigarette with synthetic cooling agents added']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alayna P. Tackett, PhD', 'role': 'CONTACT'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'The Ohio State Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'OSUCCCClinicaltrials@osumc.edu', 'phone': '800-293-5066'}], 'overallOfficials': [{'name': 'Alayna P Tackett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alayna Tackett', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}