Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-31 @ 10:23 PM
Study NCT ID:
NCT03098004
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of e-Cigarettes on Nicotine Withdrawal
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Affect Negative Affect Schedule', 'timeFrame': '4 hours', 'description': 'The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.'}, {'measure': 'The Minnesota Nicotine withdrawal Scale', 'timeFrame': '4 hours', 'description': 'The Minnesota Nicotine withdrawal Scale (MNWS) measures 11 nicotine withdrawal symptoms on 6-point response scales.'}], 'secondaryOutcomes': [{'measure': 'Wisconsin Smoking Withdrawal Scale', 'timeFrame': '4 hours', 'description': 'Additional withdrawal symptoms (e.g., hunger, concentration problems) will be measured with the Wisconsin Smoking Withdrawal Scale (WSWS).'}, {'measure': 'Questionnaire of Smoking Urges', 'timeFrame': '4 hours', 'description': '10-item Brief Questionnaire of Smoking Urges will assess desire, intention, urge and need to smoke cigarettes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electronic Cigarettes']}, 'descriptionModule': {'briefSummary': "This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet) flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of nicotine abstinence. The study's experimental design will provide evidence of the causal effects of e-cigarette flavorings on a putatively critical factor for determining whether smokers continue e-cigarette use after initial trial-the ability of a product to suppress withdrawal and motivation to smoke during periods of tobacco deprivation.", 'detailedDescription': "Nicotine withdrawal symptoms (e.g., increased negative affect, decreased positive affect, cigarette craving) are a core component of cigarette dependence that emerge upon the absence of nicotine administration, maintaining cigarette smoking and inhibiting cessation efforts. The use of electronic cigarettes (e-cigarettes) has increased dramatically in recent years, with studies demonstrating that e-cigarettes can reduce nicotine withdrawal symptoms during acute cigarette abstinence. E-cigarettes with flavorings that simulate the sweet taste of fruit, candy and other sugary foods and beverages are widely available, commonly used and are frequently cited as a reason for the persistent use of e-cigarettes. During nicotine withdrawal, sweet flavors have been shown to reduce nicotine withdrawal symptoms. Additionally, a recent USC TCORS (Tobacco Center of Regulatory Science) administrative supplement study conducted at the University of Southern California (USC) Health, Emotion, and Addiction Laboratory (USC-HEAL) found that sweet-flavored solutions enhanced the appeal of e-cigarettes, independent of nicotine. However, the impact of e-cigarette flavorings on nicotine withdrawal symptoms is currently unknown. This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet) flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of nicotine abstinence. At each visit, participants will complete a standardized e-cigarette administration procedure, as developed in our prior work, in which flavor will be manipulated in a double-blind, cross-over, counterbalanced design. Following the e-cigarette administration, participants will complete: 1) self-report measures of nicotine withdrawal symptoms; 2) physiological measurements and 3) a behavioral task that measures participants' ability to resist the desire to resume smoking under conditions in which it is advantageous to remain abstinent (i.e., monetary payment for each successive 5-min increment in which smoking is delayed). The study's experimental design will provide evidence of the causal effects of e-cigarette flavorings on a putatively critical factor for determining whether smokers continue e-cigarette use after initial trial-the ability of a product to suppress withdrawal and motivation to smoke during periods of tobacco deprivation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21 years of age or older;\n2. Daily cigarette smoking for at least the past two years;\n3. Currently smoke \\> 10 cig/day;\n4. Interest in trying e-cigarettes;\n5. report primarily smoking non-mentholated cigarettes.\n\nExclusion Criteria:\n\n1. Current use of medications that impact withdrawal or smoking (e.g., bupropion, varenicline, nicotine replacement, anti-depressants, anxiolytics);\n2. Prior use of e-cigarettes (i.e., self-report \\> 10 puffs lifetime, use on more than two occasions, purchased own device);\n3. breath carbon monoxide (CO) \\< 10 at intake;\n4. pregnancy/breastfeeding; and\n5. daily use of other tobacco products (e.g., hookah, cigars).'}, 'identificationModule': {'nctId': 'NCT03098004', 'briefTitle': 'Effects of e-Cigarettes on Nicotine Withdrawal', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers', 'orgStudyIdInfo': {'id': 'HS-16-00630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sweet-Flavored e-Cigarette', 'description': 'Participants will self-administer a sweet-flavored e-cigarette containing 3 mg/mL of nicotine.', 'interventionNames': ['Other: e-Cigarette']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobacco-Flavored e-Cigarette', 'description': 'Participants will self-administer a tobacco-flavored e-cigarette containing 3 mg/mL of nicotine.', 'interventionNames': ['Other: e-Cigarette']}], 'interventions': [{'name': 'e-Cigarette', 'type': 'OTHER', 'description': 'Participants will self-administer an experimenter-provided e-cigarette.', 'armGroupLabels': ['Sweet-Flavored e-Cigarette', 'Tobacco-Flavored e-Cigarette']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90032', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Health, Emotion and Addiction Laboratory', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adam Leventhal', 'investigatorAffiliation': 'University of Southern California'}}}}