Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT05836051
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2023-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Effect of ENDS Flavors on Neurotransmission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005421', 'term': 'Flavoring Agents'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain reward reactivity', 'timeFrame': 'Pre to post-intervention (approximately 10 days)', 'description': 'Brain reward reactivity will be calculated as the percent change in average blood oxygen-level dependent (BOLD) signal in a pre-defined ventral tegmental area (VTA) region of interest during ENDS inhalation'}, {'measure': 'Absolute reinforcement', 'timeFrame': 'Pre to post-intervention (approximately 10 days)', 'description': 'Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'Nicotine', 'Smoking', 'Addiction'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.', 'detailedDescription': 'For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. Laboratory measures of ENDS reinforcement, subjective ENDS ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fMRI) will be collected at baseline and after ten days of ENDS use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21 to 60 years old\n2. Regular users of inhaled tobacco products (≥5 days out of the last 28)\n3. Not planning to quit tobacco use within next month\n4. Able to read and write in English\n\nExclusion Criteria:\n\n1. Major neurological conditions or brain trauma\n2. Current substance use impairing participation\n3. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)\n4. Current use of smoking cessation medication (e.g., varenicline, patch)\n5. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months\n6. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin\n7. Unable to use study provided ENDS ad-libitum for at least 3 hours per day\n8. Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen\n\nMRI-specific exclusion criteria:\n\n1. MRI safety contraindications (e.g., metal implants, claustrophobia)\n2. Major neurological conditions or brain trauma'}, 'identificationModule': {'nctId': 'NCT05836051', 'acronym': 'TEN', 'briefTitle': 'Testing the Effect of ENDS Flavors on Neurotransmission', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Testing the Effect of ENDS Flavors on Neurotransmission', 'orgStudyIdInfo': {'id': '19883; 24844'}, 'secondaryIdInfos': [{'id': 'R61DA056764', 'link': 'https://reporter.nih.gov/quickSearch/R61DA056764', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hexyl Acetate', 'description': 'E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.', 'interventionNames': ['Other: Flavor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ethyl Acetate', 'description': 'E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.', 'interventionNames': ['Other: Flavor']}], 'interventions': [{'name': 'Flavor', 'type': 'OTHER', 'description': 'E-liquid flavor chemicals', 'armGroupLabels': ['Ethyl Acetate', 'Hexyl Acetate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not have explicit plans to share IPD on open-access or publicly accessible repositories. However, IPD will be de-identified and formatted along with codebooks to facilitate data sharing with investigators upon request and after the completion of a Data Use Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrea Hobkirk, PhD', 'investigatorAffiliation': 'Penn State University'}}}}