Le mag’

Poster Session 1 • Thursday, February 26, 2015 • 11:30 a.m.–1:00 p.m.
(MND) delivered (charges 2–20) was determined using gas chromatography. The
presence of specified and unspecified impurities was evaluated at 25°C and 60%
relative humidity over 18 months using high-performance liquid chromatography.
Results: MND delivered in single-day use was 0.433, 0.425, 0.429, 0.440,
0.432, 0.415 and 0.436 mg per device tested. MND delivered (charge 4) was
0.442 mg (relative standard deviation 9.7%). MND delivered over 7-day use was
0.403 and 0.415 mg (device upright and inverted, respectively). After temperature
cycling, the MND delivered was 0.424 mg both when upright and inverted. At 18
months, nicotine N-oxide and carboxylic acid impurity (both 0.2%) and myosmine
(0.1%) were detected. All individual and total levels of impurities met the product
specification at 18 months.
Conclusions: The MND values obtained were consistent across a range of
in-use conditions with no deterioration in performance over the product lifetime.
No significant levels of impurities were detected after 18 months’ storage.
FUNDING: Kind Consumer Limited and Nicoventures Limited
CORRESPONDING AUTHOR: Alan Silcock, Nicoventures Limited, 22 Tudor
Street, London, EC4Y 0AY, United Kingdom, Phone: +44 207 9360657, Email:
alan.silcock@nicoventures.co.uk
POS1-24
A NOVEL ELECTRONIC CIGARETTE WITH ADVANCED
VAPORIZATION TECHNOLOGY: NICOTINE PHARMACOKINETICS
(PK), SAFETY AND TOLERABILITY
Girish Sharma 1 , David Lawson 2 *, Ceri Edwards 1 , Anthony Clarke 3 , 1 Simbec
Research Ltd, Merthyr Tydfil, UK, 2 CN Creative Ltd, Manchester, UK, 3 Ricanto Ltd,
Henley-on-Thames, UK
Objective: To determine PK profile, safety and tolerability of nicotine delivered
via a novel electronic cigarette (EC) vs the Nicorette(R) (a registered trademark of
McNeil Products Limited) Inhalator (NI) and a conventional cigarette.
Background: There is increasing interest in EC use to reduce smoking-related
morbidity. A novel EC using advanced vaporization technology has been developed
to current regulatory standards to deliver medicinal-grade nicotine.
Design/Methods: In this randomized, open-label, crossover, Phase I study,
24 healthy men (18–65 years) who smoked 10–20 cigarettes/day for at least 5
years received nicotine using a novel EC at two dose strengths (10 [3.0% v/v] and
15 mg [4.5% v/v]), the reference product NI (15 mg) and cigarette (0.9–1.0 mg).
Participants received all 4 products in a randomized sequence on consecutive
days. One product was used 4 times at hourly intervals each day; each usage
comprised 10 inhalations (2-sec inhalations for cigarette and 3-sec inhalations for
other arms) at 30-sec intervals. PK assessments were made after the fourth use of
each product. Safety was evaluated at predetermined time points.
Results: The maximum plasma concentration (Cmax) of nicotine achieved
using the novel EC 10 or 15 mg was significantly higher than the NI (5.9 and
7.0 vs 2.6 ng/mL) and significantly lower than a cigarette (29.7 ng/mL). Median
time to Cmax (Tmax) for the EC 10 and 15 mg was significantly shorter than the
NI (8.0 and 8.0 vs 9.5 min) and significantly longer than a cigarette (2.5 min).
Nine treatment-emergent adverse events (TEAEs) were reported: novel EC 10
mg (n=2); novel EC 15 mg (n=1); NI (n=2); cigarette (n=4). TEAEs reported for
the novel EC or NI were mild or moderate in severity and considered unrelated,
or unlikely to be related, to the products. No severe or serious AEs were reported.
Conclusions: Peak nicotine plasma concentrations using the novel EC were
dose-related, significantly higher and reached more rapidly than with the NI. Peak
nicotine plasma concentrations using the novel EC were significantly lower than
after cigarette smoking. The novel EC had a safety profile similar to the NI and
was well tolerated.
FUNDING: CN Creative, a subsidiary of Nicoventures Holdings Ltd
CORRESPONDING AUTHOR: David Lawson, CN Creative Ltd, 48 Grafton Street,
Manchester, M13 9XX, United Kingdom, Phone: +44 (0)845 527 6115, Email:
david.lawson@cncbio.com
POS1-25
QUIT & FIT: A PILOT TRIAL FOR SMOKING CESSATION AND
EXERCISE PROMOTION AMONG URBAN AFRICAN-AMERICAN
WOMEN
Cassandra A. Stanton, PhD 1,2 , Ashley Huderson, PhD 2 , Bryan Kim, PhD 2 , Jennifer
Sween Hicks, MS 2 , Kepher Makambi, PhD 2 , Lucile L. Adams-Campbell, PhD 2 ,
Teletia R. Taylor, PhD 3 , Carla D. Williams, PhD 3 , 1 Westat, 2 Georgetown University
Medical Center, 3 Howard University Cancer Center
Women are 4 times more likely than men to report fear of weight gain as a reason
for smoking cessation relapse and they gain significantly more weight than male
smokers post-quit. African American (AA) women report less tolerance for postcessation
weight gain and despite lower overall smoking rates have comparable
lung cancer rates to higher smoking groups. Exercise combined with smoking
cessation can yield better cessation outcomes, yet trials to-date have not included
sufficient numbers of urban minority women. This study sought to examine how
a targeted program to promote healthy energy balance through exercise could
improve smoking cessation among urban AA women. In a pilot RCT, the feasibility
and acceptability of Quit & Fit, a 12-week smoking and exercise intervention
targeted to AA women, was examined. Participants were randomly assigned to
either a control group (SC; cessation intervention) or the Quit & Fit group (QF;
cessation plus 12-week exercise intervention). All participants received 12 weeks
of cessation counseling via telephone along with 9-weeks of NRT – lozenges).
The QF group also received objective weight measurement and 12-weeks of
structured supervised aerobic activities in a university affiliated community-based
research center. Outcome was CO biochemically confirmed 7-day intent-to-treat
abstinence post-intervention (3-months from baseline). Of the 98 screened, 28%
lacked interest in quitting, 32% were excluded due to contraindications with NRT
or exercise, and 39% (N=38, mean age 51y/o) were enrolled. Adherence to 50%
of the phone sessions was higher in the SC group (SC 44% N=8; QF 20% N=4).
At 3-month follow-up, 35% (N=7) of the QF group reported verified abstinence
compared to 16% (N=3) of controls. In the QF program, those who attended 3-6
weeks of the exercise sessions had an average 10 lb. weight reduction. Program
satisfaction was higher in the QF group (70%, N=14) compared to SC (44%, N=8).
While improving adherence to phone calls needs further study, the Quit & Fit
program was found to be feasible to deliver, acceptable to participants interested
in quitting, and more than doubled the abstinence rates in this pilot.
FUNDING: This work was supported by the National Institutes of Health/National
Cancer Institute (P30CA051008).
JUSTIFICATION: Results of this pilot trial suggest there may be great promise in
multiple health outcome interventions to address healthy behavior change among
the leading lifestyle contributors to morbidity and mortality among minority and
low-income women in this country.
CORRESPONDING AUTHOR: Cassandra Stanton, Westat & Georgetown
Univieristy 1600 Research Boulevard, Rockville, MD 20850, United States,
Phone: 401-559-5534, Email: CAS337@GEORGETOWN.EDU
POS1-26
GENDER DIFFERENCES AMONG HIV-INFECTED SMOKERS
Brittlyn K. Pearlman, BS 1 , Cassandra A. Stanton, PhD 2 , Andrea H. Weinberger,
PhD 3 , Jonathan Shuter, MD* 1 , 1 Montefiore Medical Center/Albert Einstein College
of Medicine, 2 Georgetown University Medical Center, 3 Ferkauf Graduate School of
Psychology/Yeshiva University,
Introduction: Persons living with HIV (PLWH) in the US smoke at triple the
rates of the general population. With advances in HIV care, tobacco has emerged
as a leading cause of mortality. In the general population, gender differences in
smoking behaviors are well-described, but little is known about the extent to which
demographic, clinical, or psychosocial correlates of smoking differ between men
and women living with HIV.
Methods: Positively Smoke Free (PSF) is an intensive, behavioral tobacco
treatment delivered by group therapy or over the web. We analyzed merged data
from two prospective trials of PSF for this study. All subjects were current smokers
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