User Acceptability of P3L
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 5/28/2016 |
| Start Date: | December 2015 |
| End Date: | June 2016 |
User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators
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.
The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will
be evaluated as well as the safety and tolerability of the P3L.
Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC)
smokers to use P3L to maintain their customary nicotine intake.
The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will
be evaluated as well as the safety and tolerability of the P3L.
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.
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.
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
We found this trial at
1
site
Raleigh, North Carolina 27617
Principal Investigator: Jed E. Rose, PhD
Phone: 919-328-2345
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