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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.
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.
The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P3L Product use | Experimental | 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). |
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| VUSE Product Use | Experimental | 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). |
|
| CC Product Use | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P3L | Other | Ad libitum use for a maximum of three hours. P3L delivers, on average, 80 µg of nicotine per puff under Health Canada Intense smoking regime. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. | 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). | 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. |
| Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief) | 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). Two 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. Products were compared over all timepoints using a repeated measure model using values after t0. The 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. | QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Jed E. Rose, PhD | Rose Research Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center, LLC | Raleigh | North Carolina | 27617 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11260806 | Background | 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. |
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Enrolled population = 24 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | P3L/Vuse/CC Product Exposure | Subjects followed a sequence of product exposure comprised of P3L; VUSE; CC. |
| FG001 | P3L/CC/Vuse Product Exposure | Subjects followed a sequence of product exposure comprised of P3L; CC; Vuse. |
| FG002 | Vuse/CC/P3L Product Exposure | Subjects followed a sequence of product exposure comprised of Vuse; CC; P3L. |
| FG003 | Vuse/P3L/CC Product Exposure | Subjects followed a sequence of product exposure comprised of Vuse; P3L; CC. |
| FG004 | CC/P3L/Vuse Product Exposure | Subjects followed a sequence of product exposure comprised of CC; P3L; Vuse. |
| FG005 | CC/Vuse/P3L Product Exposure | Subjects followed a sequence of product exposure comprised of the three products (CC; Vuse; P3L). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | P3L/VUSE/CC Product Exposure | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. | 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). | All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | (ng/mL) | 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. |
|
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.
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).
Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | P3L Product | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | +41 (58) 242 11 11 | ClinicalTrials.PMI@pmi.com |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| VUSE | Other | Ad libitum use for a maximum of three hours. VUSE delivers, on average, 80 µg of nicotine per puff based on the CORESTA e-cigarette recommended smoking regime. |
|
| CC | Other | Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours. |
|
| Withdrawal by Subject |
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| Protocol Adherence Issues |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | VUSE Product Exposure | 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). |
| OG002 | CC Product Exposure | 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). |
|
|
| Primary | Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief) | 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). Two 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. Products were compared over all timepoints using a repeated measure model using values after t0. The 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. | All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session. |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 14 |
| 21 |
| EG001 | VUSE Product | 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). | 0 | 19 | 0 | 19 | 13 | 19 |
| EG002 | CC Product | 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). | 0 | 19 | 0 | 19 | 9 | 19 |
| Disturbance In Attention | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Feeling Jittery | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Unevaluable Event | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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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.
The Intellectual Property rights and research results from the present study belong to the Sponsor.
| Total Score - t0 + 60mins |
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| Total Score - t0 + 120mins |
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| Total Score - t0 + 180mins |
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| Factor 1 - Over all timepoints |
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| Factor 1 - t0 + 60mins |
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| Factor 1 - t0 + 120mins |
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| Factor 1 - t0 + 180mins |
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| Factor 2 - Over all timepoints |
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| Factor 2 - t0 + 60mins |
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| Factor 2 - t0 + 120mins |
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| Factor 2 - t0 + 180mins |
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