e46 CPDD 77th Annual Meeting Abstracts (2015) / Drug and Alcohol Dependence 156 (2015) e2e101
Smoking and mental health from rst prenatal
visit to postpartum
Victoria H. Coleman-Cowger 1,2, , Bartosz
Koszowski 1 , Katrina Mark 2 , Mishka Terplan 3
1 Health & Analytics, Battelle, Baltimore, MD, United
States
2 Obstetrics, Gynecology, and Reproductive Sciences,
University of Maryland, Baltimore, MD, United States
3 Behavioral Health System Baltimore, Baltimore,
MD, United States
Aims: The study aims to describe the trajectory of smoking and
mental health from rst prenatal visit through 3 months postpar-
tum and compare postpartum outcomes based on intake smoking
status.
Methods: The sample of 130 participants was drawn from preg-
nant women attending their rst prenatal visit at a low-income
obstetrics clinic. Intake and 3 month postpartum assessments were
collected. Postpartum smoking status was based on self-report and
urine cotinine validation. Current smokers and recent quitters
were contrasted on demographic, smoking behaviors, and psycho-
logical variables.
Results: The sample was predominately African-American
(80%), never married (74%), currently smoking (69%), with a mean
age of 26. Intake and postpartum data were available for 97 (75%
follow-up rate). At intake current smokers reported smoking 66
of the past 90 days and 11 times per day (TPD); women who
recently quit reported smoking 13 of the past 90 days and 7 TPD
(between-group difference at p < .01). Current smokers reported
more depressive and stress symptoms at intake than recent quitters
and less motivation to quit (p < .05). Postpartum current smokers
reported smoking 64 of the past 90 days and 8 TPD; women who
had quit at intake smoked 1 of the past 90 days and 0.2 TPD (all at
p < .01). Depressive symptoms were not different between groups
postpartum but stress symptoms were (p < .05). Motivation to quit
declined for both groups postpartum (p < .05). The same women
who had quit at intake remained quit postpartum (28%), though
65% reported having quit smoking for at least one week during their
pregnancy.
Conclusions: Pregnant women who quit smoking prior to their
rst prenatal visit are more likely to be abstinent postpartum. Those
who continued to smoke maintained a similar level of smoking
postpartum, though a majority stopped smoking at least once dur-
ing pregnancy, suggesting motivation to quit during pregnancy
diminishes postpartum.
Financial support: Supported by a grant from the National Insti-
tute on Drug Abuse (7R34DA032683).
http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1042
Single-center, randomized, double-blind
crossover study evaluation of the abuse
potential, PK, and safety of crushed and
intranasally administered immediate release
oxycodone tablets in recreational opioid users
Salvatore Colucci 1, , Stephen Harris 1 , Kristen
Friedman 1 , Megan Shram 2
1 Purdue Pharma L.P., Stamford, CT, United States
2 Altreos Research Partners, Toronto, ON, Canada
Aims: OCI is an IR oxycodone tablet (530 mg strengths)
intended for the management of moderate to severe pain. OCI con-
tains sodium lauryl sulfate intended to deter intranasal (IN) abuse
by causing aversive effects when OCI is crushed and insufated. OCI
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also includes xanthan gum and carbopol intended to deter IV abuse
by producing a viscous solution when crushed OCI is dissolved in
small volumes of aqueous media.
Methods: A double-blind, placebo- and active-controlled, ran-
domized 4-way crossover study was conducted to evaluate the
abuse potential, PD, PK, and safety prole of IN OCI compared to
IN Roxicodone (ROX) and IN placebo (PBO) in recreational opi-
oid users. Safety was assessed using AEs, clinical laboratory tests,
vital signs, SpO2 , physical examinations, and ECGs. Assessments
included IN tolerability.
Results: Mean oxycodone PK parameters for all treatments (IN
ROX, IN OCI, and OCI intact oral [PO OCI]) were generally compa-
rable. IN OCI showed statistically signicantly less abuse potential
than IN ROX, PO OCI, or PBO on the majority of endpoints, includ-
ing the 3 primary (VAS) endpoints (at this moment Drug Liking,
Overall Drug Liking, and Take Drug Again). The majority of subjects
(63%) showed at least a 50% reduction in Emax of at this moment
Drug Liking following IN OCI as compared to IN ROX (P < 0.05). IN
OCI had signicantly higher Emax values compared to IN ROX and
PBO on most observer-rated IN irritation assessments.
Conclusions: IN OCI demonstrated signicantly lower ratings of
drug liking and willingness to take again and signicantly greater
aversive effects compared to IN ROX. These observations demon-
strate that IN OCI should be expected to reduce its IN abuse. PO OCI
produced the expected positive reinforcing effects. There were no
safety ndings of concern for any of the treatments.
Financial support: Purdue Pharma L.P.
http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1043
AlerrtTM visual analog scale: Assessing work
requirements associated with tampering of
abuse-deterrent opioid formulations
Edward J. Cone , August R. Buchhalter, Daniel W.
Wang, Jack Henningeld
PinneyAssociates, Inc., Bethesda, MD, United States
Aims: Assess the amount of work (combination of time, effort,
and resources) required to transform an abuse-deterrent (AD) opi-
oid formulation into a form suitable for intranasal, oral, rectal,
and/or smoked use or solutions that can be administered by various
routes. The measure of work is based on visual analog scales (VASs)
used for measuring behavioral effects in human abuse potential
studies.
Methods: The authors developed a new tool for use in Category
1 (in vitro tampering) studies, as dened in FDAs 2013 Draft Guid-
ance on AD opioids. The tool provides a quantitative estimate of the
amount of work involved in physical manipulations of pharmaceu-
ticals, including AD formulations (ADFs). The tool is referred to as
the Assessing Labor, Effort and Resources Required for Tampering
(ALERRTTM) scale. It is comprised of VASs designed specically to
measure work across a continuum from very easily accomplished to
extremely difcult. The scale evaluates physical manipulation prac-
tices used commonly with opioids (mortar/pestle, coffee grinder).
Four experienced laboratory technicians (DrugScan, Horsham, PA)
conducted independent assessments under standardized condi-
tions with two ADF controlled-release opioids (A and B) and a
non-ADF immediate-release (IR) opioid (C). The opioid formu-
lations were assessed in random order. Each assessment was
preceded by a calibration procedure. The primary analysis exam-
ined the difference in mean VAS scores between A and B and A and
C. Results were interpreted descriptively and directionally.
Results: There was a trend across the 3 products indicative of
the difculty of tamperabilty such that A > B C. These data were