Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-04-14 @ 1:39 PM
Study NCT ID:
NCT05457634
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-13', 'size': 576293, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-02T07:31', 'hasProtocol': True}, {'date': '2021-08-02', 'size': 830732, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-02T07:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Outcome: heart rate after defined use', 'timeFrame': 'At 8 minutes relative to first puff of defined use session', 'description': 'Heart rate after the subject has spent at least 5 minutes in the seated position'}, {'measure': 'Safety Outcome: heart rate after ad libitum use', 'timeFrame': 'At 60 minutes relative to first puff of ad libitum use session', 'description': 'Heart rate after the subject has spent at least 5 minutes in the seated position'}, {'measure': 'Safety Outome: systolic blood pressure after defined use', 'timeFrame': 'At 8 minutes relative to first puff of defined use session', 'description': 'Blood pressure measured after the subject has spent at least 5 minutes in the seated position'}, {'measure': 'Safety Outome: systolic blood pressure after ad libitum use', 'timeFrame': 'At 60 minutes relative to first puff of ad libitum use session', 'description': 'Blood pressure measured after the subject has spent at least 5 minutes in the seated position'}, {'measure': 'Safety Outome: diastolic blood pressure after defined use', 'timeFrame': 'At 8 minutes relative to first puff of defined use session', 'description': 'Blood pressure measured after the subject has spent at least 5 minutes in the seated position'}, {'measure': 'Safety Outome: diastolic blood pressure after ad libitum use', 'timeFrame': 'At 60 minutes relative to first puff of ad libitum use session', 'description': 'Blood pressure measured after the subject has spent at least 5 minutes in the seated position'}], 'primaryOutcomes': [{'measure': 'Nicotine Cmax0-120', 'timeFrame': '5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff', 'description': 'Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine'}, {'measure': 'Nicotine Cmax120-180', 'timeFrame': 'at 15, 30, 45, and 60 minutes after the start of the ad libitum use session (ad libitum session starts at 120 min relative to first puff of controlled use session)', 'description': 'Maximum plasma nicotine concentration during the ad libitum use session, adjusted for baseline nicotine'}, {'measure': 'Nicotine AUC0-120', 'timeFrame': '5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff', 'description': 'Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session'}, {'measure': 'Nicotine AUC120-180', 'timeFrame': 'at 15, 30, 45, and 60 minutes after the start of the ad libitum use session', 'description': 'Area under the plasma nicotine concentration-time curve from time 120 minutes to 180 minutes, i.e. during the ad libitum use session'}, {'measure': 'Urge to Smoke - Defined use', 'timeFrame': '5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff', 'description': 'Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.'}, {'measure': 'Urge to Smoke - Ad libitum use', 'timeFrame': 'at 15, 30, 45, and 60 minutes after the start of the ad libitum use session', 'description': 'Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.'}], 'secondaryOutcomes': [{'measure': 'Puff topography: puff count', 'timeFrame': 'Throughout ad libitum use session (60 minutes)', 'description': 'Measured during the ad libitum use session with a CReSS Pocket topography device'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "This study assesses the nicotine uptake, abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography are evaluated and compared with subjects' usual brand combustible cigarette."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes\n* Subjects have urine cotinine \\>200 ng/mL and exhaled carbon monoxide \\> 10 ppm at Screening\n* Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure\n\n ≤95 mmHg, and heart rate ≤100 bpm\n* Females of childbearing potential who are practicing a reliable method of contraception\n\nExclusion Criteria:\n\n* Subjects who have used any nicotine or tobacco product other than e-cigarettes or combustible cigarettes in the 14 days prior to Visit 1\n* Subjects who have an acute illness requiring treatment in the 4 weeks prior to Visit 1\n* Subjects with clinically significant and relevant abnormalities of medical history.\n* Subjects who have used any prescription or over-the-counter smoking cessation treatments within 30 days prior to Visit 1\n* Pregnant or breastfeeding female subjects'}, 'identificationModule': {'nctId': 'NCT05457634', 'briefTitle': 'Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fontem Ventures BV'}, 'officialTitle': 'Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette', 'orgStudyIdInfo': {'id': 'Fontem-PK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'blu Disposable Flavor A', 'description': 'Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A', 'interventionNames': ['Other: blu Disposable A']}, {'type': 'EXPERIMENTAL', 'label': 'blu Disposable Flavor B', 'description': 'Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B', 'interventionNames': ['Other: blu Disposable B']}, {'type': 'EXPERIMENTAL', 'label': 'blu Disposable Flavor C', 'description': 'Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C', 'interventionNames': ['Other: blu Disposable C']}, {'type': 'EXPERIMENTAL', 'label': 'blu Disposable Flavor D', 'description': 'Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D', 'interventionNames': ['Other: blu Disposable D']}, {'type': 'EXPERIMENTAL', 'label': 'blu Disposable Flavor E', 'description': 'Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E', 'interventionNames': ['Other: blu Disposable E']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combustible cigarette', 'description': 'Subjects who use their own brand of combustible cigarette', 'interventionNames': ['Other: Combustible Cigarette']}], 'interventions': [{'name': 'Combustible Cigarette', 'type': 'OTHER', 'description': 'Subjects smoke their Usual Brand Combustible Cigarette, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.', 'armGroupLabels': ['Combustible cigarette']}, {'name': 'blu Disposable A', 'type': 'OTHER', 'description': 'Subjects use the blu disposable e-cigarette with flavor A, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.', 'armGroupLabels': ['blu Disposable Flavor A']}, {'name': 'blu Disposable B', 'type': 'OTHER', 'description': 'Subjects use the blu disposable e-cigarette with flavor B, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.', 'armGroupLabels': ['blu Disposable Flavor B']}, {'name': 'blu Disposable C', 'type': 'OTHER', 'description': 'Subjects use the blu disposable e-cigarette with flavor C, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.', 'armGroupLabels': ['blu Disposable Flavor C']}, {'name': 'blu Disposable D', 'type': 'OTHER', 'description': 'Subjects use the blu disposable e-cigarette with flavor D, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.', 'armGroupLabels': ['blu Disposable Flavor D']}, {'name': 'blu Disposable E', 'type': 'OTHER', 'description': 'Subjects use the blu disposable e-cigarette with flavor E, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.', 'armGroupLabels': ['blu Disposable Flavor E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'LA Clinical Trials, LLC', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fontem US LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}