Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-04-14 @ 4:31 PM
Study NCT ID:
NCT02179034
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D008610', 'term': 'Menthol'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liking/effect score of the e-cigarette', 'timeFrame': 'Every 30 min for 120 min during lab session', 'description': "The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor."}], 'secondaryOutcomes': [{'measure': 'Maximum value of money at which the e-cigarette is chosen over money', 'timeFrame': 'Every 30 min for 120 min during lab session', 'description': 'E-cigarette value will be determined using the Multiple Choice Procedure (Griffiths et al, 1993) to determine the reinforcing value of the e-cigarette. The MCP involves sampling the e-cigarette and then making a discrete choice between the e-cigarette or a series of monetary values.'}, {'measure': 'Change scores from baseline in Nicotine Withdrawal', 'timeFrame': 'Every 30 min for 120 min during lab session', 'description': 'The Minnesota Nicotine Withdrawal Scale (Hughes et al,1986) will be used to assess the magnitude of change in nicotine withdrawal symptoms during the lab session'}, {'measure': 'Change scores from baseline in Tobacco Craving', 'timeFrame': 'Every 30 min for 120 min during lab session', 'description': 'The Brief Questionnaire on Smoking Urges (Tiffany \\& Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tobacco', 'electronic cigarettes', 'menthol', 'flavors'], 'conditions': ['Nicotine Dependence, Other Tobacco Product']}, 'descriptionModule': {'briefSummary': 'This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '20 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-20 years\n* Able to read and write\n* Cigarette smoker\n* Use of e-cigarettes in the past 30 days\n\nExclusion Criteria:\n\n* Seeking smoking cessation treatment\n* Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants\n* Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants\n* Current or past history of psychosis or other psychiatric diagnosis such as major depression\n* Any significant current medical condition'}, 'identificationModule': {'nctId': 'NCT02179034', 'briefTitle': 'Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1', 'orgStudyIdInfo': {'id': '1307012312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Tobacco Flavor', 'description': 'In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.', 'interventionNames': ['Other: Low Dose Menthol', 'Other: High Dose Menthol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose Nicotine', 'description': 'In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.', 'interventionNames': ['Drug: Nicotine', 'Other: Low Dose Menthol', 'Other: High Dose Menthol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose Nicotine', 'description': 'In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.', 'interventionNames': ['Drug: Nicotine', 'Other: Low Dose Menthol', 'Other: High Dose Menthol']}], 'interventions': [{'name': 'Nicotine', 'type': 'DRUG', 'description': 'Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)', 'armGroupLabels': ['High Dose Nicotine', 'Low Dose Nicotine']}, {'name': 'Low Dose Menthol', 'type': 'OTHER', 'description': 'A low dose of menthol will be added to the tobacco flavor.', 'armGroupLabels': ['High Dose Nicotine', 'Low Dose Nicotine', 'Tobacco Flavor']}, {'name': 'High Dose Menthol', 'type': 'OTHER', 'description': 'A high dose of menthol will be added to the tobacco flavor.', 'armGroupLabels': ['High Dose Nicotine', 'Low Dose Nicotine', 'Tobacco Flavor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CMHC', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Dana Cavallo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}