User Acceptability of a Nicotine Lactate Delivery System (P3L)

Completed · Not applicable

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT02643693

Run by

Philip Morris Products S.A.

People needed

24

Starts

2015-11-01

Expected to finish

2016-12-01

Last updated by the study team

2019-08-01

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rose Research Center, LLC — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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