N/A
N=24
User Acceptability of a Nicotine Lactate Delivery System (P3L)
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02643693 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. — 1.7621; 2.4113; 1.9446; 5.5571 (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P3L (Other); VUSE (Other); CC (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. |
1.7621; 2.4113; 1.9446; 5.5571; 7.3425; 17.1821 | — |
| PRIMARY Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief) |
3.86; 3.08; 1.93; 4.02; 3.24; 2.09 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Smoking, healthy subject as judged by the Investigator
- Subject smoked at least 10 commercially available non-menthol CCs per day for the last 12 months
- Subject does not plan to quit smoking in the next 60 days
Exclusion Criteria
- As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
- Subject has donated or been in receipt of whole blood or blood products within 3 months prior to the screening visit
- Subject has used tobacco products or nicotine containing products other than CCs within 30 days prior to the screening visit
- Female subject is pregnant or breast feeding
- Female subject does not agree to use an acceptable method of effective contraception
- Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy
Data sourced from ClinicalTrials.gov (NCT02643693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.