Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-21 @ 9:59 PM
Study NCT ID:
NCT02643693
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
User Acceptability of a Nicotine Lactate Delivery System (P3L)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.PMI@pmi.com', 'phone': '+41 (58) 242 11 11', 'title': 'Christelle Haziza, PhD', 'organization': 'Philip Morris Products S.A.'}, 'certainAgreement': {'otherDetails': "We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.\n\nThe Intellectual Property rights and research results from the present study belong to the Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.', 'description': 'The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC).\n\nOverall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'P3L Product', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 14, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VUSE Product', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 13, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CC Product', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Disturbance In Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Feeling Jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Unevaluable Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P3L Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}, {'id': 'OG001', 'title': 'VUSE Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}, {'id': 'OG002', 'title': 'CC Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}], 'classes': [{'title': 'Baseline (Average) before session: Nicotine', 'categories': [{'measurements': [{'value': '1.7621', 'groupId': 'OG000', 'lowerLimit': '1.1308', 'upperLimit': '2.7459'}, {'value': '2.4113', 'groupId': 'OG001', 'lowerLimit': '1.8529', 'upperLimit': '3.1378'}, {'value': '1.9446', 'groupId': 'OG002', 'lowerLimit': '1.5375', 'upperLimit': '2.4594'}]}]}, {'title': 'Change from Baseline after session: Nicotine', 'categories': [{'measurements': [{'value': '5.5571', 'groupId': 'OG000', 'lowerLimit': '3.5802', 'upperLimit': '8.6255'}, {'value': '7.3425', 'groupId': 'OG001', 'lowerLimit': '4.7138', 'upperLimit': '11.4371'}, {'value': '17.1821', 'groupId': 'OG002', 'lowerLimit': '13.7633', 'upperLimit': '21.4500'}]}]}, {'title': 'Baseline (Average) before session: Cotinine', 'categories': [{'measurements': [{'value': '182.554', 'groupId': 'OG000', 'lowerLimit': '148.073', 'upperLimit': '225.065'}, {'value': '187.559', 'groupId': 'OG001', 'lowerLimit': '147.914', 'upperLimit': '237.828'}, {'value': '199.547', 'groupId': 'OG002', 'lowerLimit': '161.636', 'upperLimit': '246.351'}]}]}, {'title': 'Change from Baseline after session: Cotinine', 'categories': [{'measurements': [{'value': '15.222', 'groupId': 'OG000', 'lowerLimit': '10.116', 'upperLimit': '22.905'}, {'value': '11.163', 'groupId': 'OG001', 'lowerLimit': '5.523', 'upperLimit': '22.561'}, {'value': '33.888', 'groupId': 'OG002', 'lowerLimit': '24.004', 'upperLimit': '47.842'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.', 'description': 'For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).', 'unitOfMeasure': '(ng/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P3L Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}, {'id': 'OG001', 'title': 'VUSE Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}, {'id': 'OG002', 'title': 'CC Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}], 'classes': [{'title': 'Total Score - Over all timepoints', 'categories': [{'measurements': [{'value': '3.86', 'groupId': 'OG000', 'lowerLimit': '3.36', 'upperLimit': '4.36'}, {'value': '3.08', 'groupId': 'OG001', 'lowerLimit': '2.58', 'upperLimit': '3.58'}, {'value': '1.93', 'groupId': 'OG002', 'lowerLimit': '1.43', 'upperLimit': '2.42'}]}]}, {'title': 'Total Score - t0 + 60mins', 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '3.51', 'upperLimit': '4.52'}, {'value': '3.24', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '3.74'}, {'value': '2.09', 'groupId': 'OG002', 'lowerLimit': '1.58', 'upperLimit': '2.59'}]}]}, {'title': 'Total Score - t0 + 120mins', 'categories': [{'measurements': [{'value': '3.84', 'groupId': 'OG000', 'lowerLimit': '3.33', 'upperLimit': '4.36'}, {'value': '3.07', 'groupId': 'OG001', 'lowerLimit': '2.56', 'upperLimit': '3.58'}, {'value': '1.91', 'groupId': 'OG002', 'lowerLimit': '1.40', 'upperLimit': '2.42'}]}]}, {'title': 'Total Score - t0 + 180mins', 'categories': [{'measurements': [{'value': '3.71', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.23'}, {'value': '2.94', 'groupId': 'OG001', 'lowerLimit': '2.42', 'upperLimit': '3.45'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '1.27', 'upperLimit': '2.29'}]}]}, {'title': 'Factor 1 - Over all timepoints', 'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '4.39', 'upperLimit': '5.54'}, {'value': '4.11', 'groupId': 'OG001', 'lowerLimit': '3.54', 'upperLimit': '4.68'}, {'value': '2.15', 'groupId': 'OG002', 'lowerLimit': '1.58', 'upperLimit': '2.73'}]}]}, {'title': 'Factor 1 - t0 + 60mins', 'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '4.28', 'upperLimit': '5.46'}, {'value': '4.48', 'groupId': 'OG001', 'lowerLimit': '3.89', 'upperLimit': '5.06'}, {'value': '2.53', 'groupId': 'OG002', 'lowerLimit': '1.94', 'upperLimit': '3.12'}]}]}, {'title': 'Factor 1 - t0 + 120mins', 'categories': [{'measurements': [{'value': '4.99', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '5.64'}, {'value': '4.11', 'groupId': 'OG001', 'lowerLimit': '3.46', 'upperLimit': '4.77'}, {'value': '2.08', 'groupId': 'OG002', 'lowerLimit': '1.42', 'upperLimit': '2.74'}]}]}, {'title': 'Factor 1 - t0 + 180mins', 'categories': [{'measurements': [{'value': '5.05', 'groupId': 'OG000', 'lowerLimit': '4.43', 'upperLimit': '5.66'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '3.13', 'upperLimit': '4.35'}, {'value': '1.84', 'groupId': 'OG002', 'lowerLimit': '1.23', 'upperLimit': '2.46'}]}]}, {'title': 'Factor 2 - Over all timepoints', 'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '3.36'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '2.66'}, {'value': '1.60', 'groupId': 'OG002', 'lowerLimit': '1.10', 'upperLimit': '2.11'}]}]}, {'title': 'Factor 2 - t0 + 60mins', 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '3.48'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '1.73', 'upperLimit': '2.78'}, {'value': '1.71', 'groupId': 'OG002', 'lowerLimit': '1.19', 'upperLimit': '2.23'}]}]}, {'title': 'Factor 2 - t0 + 120mins', 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '3.35'}, {'value': '2.14', 'groupId': 'OG001', 'lowerLimit': '1.63', 'upperLimit': '2.65'}, {'value': '1.59', 'groupId': 'OG002', 'lowerLimit': '1.09', 'upperLimit': '2.10'}]}]}, {'title': 'Factor 2 - t0 + 180mins', 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '3.28'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.54', 'upperLimit': '2.58'}, {'value': '1.51', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.03'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.', 'description': "The QSU-Brief questionnaire is an instrument used to measure urge to smoke. Subjects were asked to respond to 10 questions, scored from 1 to 7 on a 7-point scale. A score of 1 on this scale indicates a very low urge to smoke, while a score of 7 indicates a very high urge to smoke. Subjects were asked to complete the questionnaire before, during, and after each ad libitum product use session. (P3L, VUSE, and Subjects' Own Brand of Non-menthol CC).\n\nTwo factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke.\n\nProducts were compared over all timepoints using a repeated measure model using values after t0.\n\nThe model adjusted for baseline value, sequence, and period with repeated measure over time and a random effect in subjects. Adjusted mean over all timepoints, for each timepoint, were estimated.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'P3L/Vuse/CC Product Exposure', 'description': 'Subjects followed a sequence of product exposure comprised of P3L; VUSE; CC.'}, {'id': 'FG001', 'title': 'P3L/CC/Vuse Product Exposure', 'description': 'Subjects followed a sequence of product exposure comprised of P3L; CC; Vuse.'}, {'id': 'FG002', 'title': 'Vuse/CC/P3L Product Exposure', 'description': 'Subjects followed a sequence of product exposure comprised of Vuse; CC; P3L.'}, {'id': 'FG003', 'title': 'Vuse/P3L/CC Product Exposure', 'description': 'Subjects followed a sequence of product exposure comprised of Vuse; P3L; CC.'}, {'id': 'FG004', 'title': 'CC/P3L/Vuse Product Exposure', 'description': 'Subjects followed a sequence of product exposure comprised of CC; P3L; Vuse.'}, {'id': 'FG005', 'title': 'CC/Vuse/P3L Product Exposure', 'description': 'Subjects followed a sequence of product exposure comprised of the three products (CC; Vuse; P3L).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Adherence Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study initiated (1st subject screened): 16 November 2015 A demonstration of the P3L system and the VUSE e-cigarette system was given to the subjects.', 'preAssignmentDetails': 'Enrolled population = 24 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.\n\nSubject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'P3L/VUSE/CC Product Exposure', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<=19 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 19 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-19', 'studyFirstSubmitDate': '2015-12-17', 'resultsFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2015-12-28', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-20', 'studyFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.', 'timeFrame': 'Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.', 'description': 'For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).'}, {'measure': 'Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)', 'timeFrame': 'QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.', 'description': "The QSU-Brief questionnaire is an instrument used to measure urge to smoke. Subjects were asked to respond to 10 questions, scored from 1 to 7 on a 7-point scale. A score of 1 on this scale indicates a very low urge to smoke, while a score of 7 indicates a very high urge to smoke. Subjects were asked to complete the questionnaire before, during, and after each ad libitum product use session. (P3L, VUSE, and Subjects' Own Brand of Non-menthol CC).\n\nTwo factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke.\n\nProducts were compared over all timepoints using a repeated measure model using values after t0.\n\nThe model adjusted for baseline value, sequence, and period with repeated measure over time and a random effect in subjects. Adjusted mean over all timepoints, for each timepoint, were estimated."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conventional cigarette', 'Nicotine lactate delivery system', 'e-cigarette', 'VUSE', 'Combustible cigarette'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '11260806', 'type': 'BACKGROUND', 'citation': 'Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.'}]}, 'descriptionModule': {'briefSummary': 'This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with their own brand of CC or the VUSE e-cigarette system.', 'detailedDescription': "The total duration of the study for an individual subject will be between 3 and 8 weeks, including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the preference evaluation session (subjects will be given the choice of using ad libitum the P3L or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive safety follow-up period.\n\nThe pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoking, healthy subject as judged by the Investigator\n* Subject smoked at least 10 commercially available non-menthol CCs per day for the last 12 months\n* Subject does not plan to quit smoking in the next 60 days\n\nExclusion Criteria:\n\n* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)\n* Subject has donated or been in receipt of whole blood or blood products within 3 months prior to the screening visit\n* Subject has used tobacco products or nicotine containing products other than CCs within 30 days prior to the screening visit\n* Female subject is pregnant or breast feeding\n* Female subject does not agree to use an acceptable method of effective contraception\n* Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy'}, 'identificationModule': {'nctId': 'NCT02643693', 'briefTitle': 'User Acceptability of a Nicotine Lactate Delivery System (P3L)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators', 'orgStudyIdInfo': {'id': 'P3L-PK-02-US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P3L Product use', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).', 'interventionNames': ['Other: P3L']}, {'type': 'EXPERIMENTAL', 'label': 'VUSE Product Use', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).', 'interventionNames': ['Other: VUSE']}, {'type': 'EXPERIMENTAL', 'label': 'CC Product Use', 'description': 'Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).', 'interventionNames': ['Other: CC']}], 'interventions': [{'name': 'P3L', 'type': 'OTHER', 'description': 'Ad libitum use for a maximum of three hours.\n\nP3L delivers, on average, 80 µg of nicotine per puff under Health Canada Intense smoking regime.', 'armGroupLabels': ['P3L Product use']}, {'name': 'VUSE', 'type': 'OTHER', 'description': 'Ad libitum use for a maximum of three hours.\n\nVUSE delivers, on average, 80 µg of nicotine per puff based on the CORESTA e-cigarette recommended smoking regime.', 'armGroupLabels': ['VUSE Product Use']}, {'name': 'CC', 'type': 'OTHER', 'description': "Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.", 'armGroupLabels': ['CC Product Use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27617', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rose Research Center, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'Christelle Haziza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}, {'name': 'Jed E. Rose, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rose Research Center, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}