User Acceptability of a Nicotine Lactate Delivery System (P3L)

NCT02643693 | Completed Results

• 1 other identifier: P3L-PK-02-US
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

Conventional cigarette; Nicotine lactate delivery system; e-cigarette; VUSE; Combustible cigarette

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

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).

Other: P3L

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).

Other: VUSE

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).

Other: CC

Interventions

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.

P3L Product use

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.

VUSE Product Use

CC OTHER

Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.

CC Product Use

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Rose Research Center, LLC

Raleigh, North Carolina, 27617, United States

Location

Related Publications (1)

• 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.

  PMID: 11260806 BACKGROUND

MeSH Terms

Conditions

Smoking; Vaping

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle Haziza, PhD
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 (58) 242 11 11

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

• Jed E. Rose, PhD

  Rose Research Center, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 31, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 1, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)