- Email: [email protected]
Alerrt™ visual analog scale: Assessing “work” requirements associated with tampering of abuse-deterrent opioid formulations
e46
CPDD 77th Annual Meeting Abstracts (2015) / Drug and Alcohol Dependence 156 (2015) e2–e101
Smoking and mental health from first 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 first prenatal visit through 3 months postpartum and compare postpartum outcomes based on intake smoking status. Methods: The sample of 130 participants was drawn from pregnant women attending their first 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 psychological 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 first 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 during pregnancy, suggesting motivation to quit during pregnancy diminishes postpartum. Financial support: Supported by a grant from the National Institute 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 2
Purdue Pharma L.P., Stamford, CT, United States Altreos Research Partners, Toronto, ON, Canada
Aims: OCI is an IR oxycodone tablet (5–30 mg strengths) intended for the management of moderate to severe pain. OCI contains sodium lauryl sulfate intended to deter intranasal (IN) abuse by causing aversive effects when OCI is crushed and insufflated. OCI
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, randomized 4-way crossover study was conducted to evaluate the abuse potential, PD, PK, and safety profile of IN OCI compared to IN Roxicodone (ROX) and IN placebo (PBO) in recreational opioid 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 comparable. IN OCI showed statistically significantly less abuse potential than IN ROX, PO OCI, or PBO on the majority of endpoints, including 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 significantly higher Emax values compared to IN ROX and PBO on most observer-rated IN irritation assessments. Conclusions: IN OCI demonstrated significantly lower ratings of drug liking and willingness to take again and significantly greater aversive effects compared to IN ROX. These observations demonstrate that IN OCI should be expected to reduce its IN abuse. PO OCI produced the expected positive reinforcing effects. There were no safety findings 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 Henningfield 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) opioid 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 defined in FDA’s 2013 Draft Guidance on AD opioids. The tool provides a quantitative estimate of the amount of work involved in physical manipulations of pharmaceuticals, 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 specifically to measure work across a continuum from very easily accomplished to extremely difficult. The scale evaluates physical manipulation practices used commonly with opioids (mortar/pestle, coffee grinder). Four experienced laboratory technicians (DrugScan, Horsham, PA) conducted independent assessments under standardized conditions with two ADF controlled-release opioids (A and B) and a non-ADF immediate-release (IR) opioid (C). The opioid formulations were assessed in random order. Each assessment was preceded by a calibration procedure. The primary analysis examined 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 difficulty of tamperabilty such that A > B » C. These data were
CPDD 77th Annual Meeting Abstracts (2015) / Drug and Alcohol Dependence 156 (2015) e2–e101
consistent with subjective perceptions that product A exhibited higher resistance to tampering than product B and substantially greater resistance than product C. Conclusions: The ALERRT scale provided a quantitative measure of work required for tampering with ADFs. Product A demonstrated the highest work requirement. Financial support: PinneyAssociates received no financial support. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1044 Women can force men to have sex? Forced sex tactic and substance use among sexually victimized men Mekeila Cook Integrated Substance Abuse Programs, University of California, Los Angeles, Los Angeles, CA, United States Aims: Sexual violence towards men by women has been grossly understudied in the literature. Moreover, the tactics used to force sex among men is virtually unknown. The aims were to investigate: (1) the tactics used to force men to have sex and (2) the role of substance use on forced sex and the tactics employed. Methods: I used data from the National Survey for Family Growth (2006–2010) to investigate the association between forced sex and substance use among men who reported forced sex by a woman and the association between tactic used during the sexual attack and substance use in the last year. Six tactics were ranked according to force exhorted: given drugs/alcohol, bigger/older, threats to relationship, threaten physical harm, held down, physically hurt. The analytic sample was 8,108 and I used logistic regression to test the hypotheses. Results: Five percent of men (N = 501) reported forced sex by a woman. The top 3 tactics endorsed were verbal pressure (69%), given drugs/alcohol (38%), and being held down (32%). Results indicate a difference in rates of marijuana use (p = 0.02), crack use (p < 0.001), crystal meth use (p < 0.001) and a marginal difference for binge drinking (p = 0.058) between men who reported forced sex and those who did not. Being given drugs or alcohol as a means of forced sex was associated with binge drinking (OR = 1.76) and cocaine use (OR = 3.04). Being held down was associated with marijuana (OR = 2.04) and cocaine use (OR = 2.89). Conclusions: Men who reported forced sex had higher rates of substance use compared to men with no forced sex history. Although substance use was associated with force tactics at statistically significant levels, a clear trend of stronger tactics being associated with substance use was not observed. Longitudinal analysis of sexual practices should be conducted to better understand the role of alcohol/drug consumption preceding a forced sex event and to examine whether there is a cycle in which substance use increases risk of future sexual violence and thus violence increases risk of substance use among men. Financial support: 5T32DA00727222. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1045
e47
Marijuana use and undetectable HIV viral load in persons living with HIV in Florida Robert Cook 3,∗ , Zhi Zhou 3 , Chukwuemeka Okafor 3 , Christa Cook 1 , Larry Burrell 2 , Nicole E. Whitehead 2 , Jeffrey Harman 4 1
College of Nursing, University of Florida, Gainesville, FL, United States 2 Clinical and Health Psychology, University of Florida, Gainesville, FL, United States 3 Epidemiology, University of Florida, Gainesville, FL, United States 4 Health Services Research Management and Policy, University of Florida, Gainesville, FL, United States Aims: Helping PLWH to obtain an undetectable HIV viral load is part of the National HIV Strategy. Marijuana use is common among PLWH but little is known about its association viral load suppression. We sought to determine the association between marijuana use and undetectable viral load, and to assess the impact of antiretroviral (ART) medication adherence on this outcome. Methods: We used data from the Florida Medical Monitoring Project (2009–2010), a CDC-sponsored study from a random sample of persons receiving HIV care in Florida. Marijuana use was characterized as any (past year) vs. none; undetectable viral load (200 copies/mL) was determined by chart abstraction. Multivariable logistic regression was used to determine the association between marijuana use and undetectable viral load while adjusting for demographic factors, depression, other substance use, and ART adherence (95% or more). Results: Of the overall sample (n = 803), 76% (n = 528) had an undetectable viral load, 22% (n = 173) reported any marijuana use in the past 12 months, including 7.7% (n = 61) with daily use. Among those currently on ART (n = 628), marijuana users were less likely to achieve an undetectable viral load (72% vs. 83%, p = 0.018). In multivariable analysis, marijuana use was associated with a significantly decreased likelihood of having an undetectable viral load (OR: 0.57, 95% CI: 0.38–0.88). When adjusting for ART adherence, marijuana users remained less likely to have an undetectable viral load (OR: 0.65, 95% CI: 0.40–1.05), although the result was not statistically significant. Conclusions: Marijuana use was relatively common in this sample of persons with HIV and was associated with a reduced likelihood of having an undetectable viral load. This relationship appeared to be partially, but not completely, related to nonadherence to ART. Financial support: Research was supported in part by NIH grant AAU2402002. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1046 Impact of adolescent marijuana use on emotion processing: An fMRI study Lora M. Cope ∗ , Jillian Hardee, Meghan E. Martz, Robert Zucker, Mary Heitzeg University of Michigan, Ann Arbor, MI, United States Aims: Marijuana is the most commonly used illicit drug in the U.S. Evidence exists for a potentially causal link between adolescent marijuana use and mood disorders later in life. Thus, the aim of this study was to examine associations among early marijuana use, emotion-related brain activity, and later emotional outcomes in young adults. Methods: Participants were forty 17–22 year old males and females from an ongoing fMRI longitudinal study. They were
CPDD 77th Annual Meeting Abstracts (2015) / Drug and Alcohol Dependence 156 (2015) e2–e101
Smoking and mental health from first 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 first prenatal visit through 3 months postpartum and compare postpartum outcomes based on intake smoking status. Methods: The sample of 130 participants was drawn from pregnant women attending their first 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 psychological 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 first 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 during pregnancy, suggesting motivation to quit during pregnancy diminishes postpartum. Financial support: Supported by a grant from the National Institute 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 2
Purdue Pharma L.P., Stamford, CT, United States Altreos Research Partners, Toronto, ON, Canada
Aims: OCI is an IR oxycodone tablet (5–30 mg strengths) intended for the management of moderate to severe pain. OCI contains sodium lauryl sulfate intended to deter intranasal (IN) abuse by causing aversive effects when OCI is crushed and insufflated. OCI
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, randomized 4-way crossover study was conducted to evaluate the abuse potential, PD, PK, and safety profile of IN OCI compared to IN Roxicodone (ROX) and IN placebo (PBO) in recreational opioid 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 comparable. IN OCI showed statistically significantly less abuse potential than IN ROX, PO OCI, or PBO on the majority of endpoints, including 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 significantly higher Emax values compared to IN ROX and PBO on most observer-rated IN irritation assessments. Conclusions: IN OCI demonstrated significantly lower ratings of drug liking and willingness to take again and significantly greater aversive effects compared to IN ROX. These observations demonstrate that IN OCI should be expected to reduce its IN abuse. PO OCI produced the expected positive reinforcing effects. There were no safety findings 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 Henningfield 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) opioid 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 defined in FDA’s 2013 Draft Guidance on AD opioids. The tool provides a quantitative estimate of the amount of work involved in physical manipulations of pharmaceuticals, 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 specifically to measure work across a continuum from very easily accomplished to extremely difficult. The scale evaluates physical manipulation practices used commonly with opioids (mortar/pestle, coffee grinder). Four experienced laboratory technicians (DrugScan, Horsham, PA) conducted independent assessments under standardized conditions with two ADF controlled-release opioids (A and B) and a non-ADF immediate-release (IR) opioid (C). The opioid formulations were assessed in random order. Each assessment was preceded by a calibration procedure. The primary analysis examined 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 difficulty of tamperabilty such that A > B » C. These data were
CPDD 77th Annual Meeting Abstracts (2015) / Drug and Alcohol Dependence 156 (2015) e2–e101
consistent with subjective perceptions that product A exhibited higher resistance to tampering than product B and substantially greater resistance than product C. Conclusions: The ALERRT scale provided a quantitative measure of work required for tampering with ADFs. Product A demonstrated the highest work requirement. Financial support: PinneyAssociates received no financial support. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1044 Women can force men to have sex? Forced sex tactic and substance use among sexually victimized men Mekeila Cook Integrated Substance Abuse Programs, University of California, Los Angeles, Los Angeles, CA, United States Aims: Sexual violence towards men by women has been grossly understudied in the literature. Moreover, the tactics used to force sex among men is virtually unknown. The aims were to investigate: (1) the tactics used to force men to have sex and (2) the role of substance use on forced sex and the tactics employed. Methods: I used data from the National Survey for Family Growth (2006–2010) to investigate the association between forced sex and substance use among men who reported forced sex by a woman and the association between tactic used during the sexual attack and substance use in the last year. Six tactics were ranked according to force exhorted: given drugs/alcohol, bigger/older, threats to relationship, threaten physical harm, held down, physically hurt. The analytic sample was 8,108 and I used logistic regression to test the hypotheses. Results: Five percent of men (N = 501) reported forced sex by a woman. The top 3 tactics endorsed were verbal pressure (69%), given drugs/alcohol (38%), and being held down (32%). Results indicate a difference in rates of marijuana use (p = 0.02), crack use (p < 0.001), crystal meth use (p < 0.001) and a marginal difference for binge drinking (p = 0.058) between men who reported forced sex and those who did not. Being given drugs or alcohol as a means of forced sex was associated with binge drinking (OR = 1.76) and cocaine use (OR = 3.04). Being held down was associated with marijuana (OR = 2.04) and cocaine use (OR = 2.89). Conclusions: Men who reported forced sex had higher rates of substance use compared to men with no forced sex history. Although substance use was associated with force tactics at statistically significant levels, a clear trend of stronger tactics being associated with substance use was not observed. Longitudinal analysis of sexual practices should be conducted to better understand the role of alcohol/drug consumption preceding a forced sex event and to examine whether there is a cycle in which substance use increases risk of future sexual violence and thus violence increases risk of substance use among men. Financial support: 5T32DA00727222. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1045
e47
Marijuana use and undetectable HIV viral load in persons living with HIV in Florida Robert Cook 3,∗ , Zhi Zhou 3 , Chukwuemeka Okafor 3 , Christa Cook 1 , Larry Burrell 2 , Nicole E. Whitehead 2 , Jeffrey Harman 4 1
College of Nursing, University of Florida, Gainesville, FL, United States 2 Clinical and Health Psychology, University of Florida, Gainesville, FL, United States 3 Epidemiology, University of Florida, Gainesville, FL, United States 4 Health Services Research Management and Policy, University of Florida, Gainesville, FL, United States Aims: Helping PLWH to obtain an undetectable HIV viral load is part of the National HIV Strategy. Marijuana use is common among PLWH but little is known about its association viral load suppression. We sought to determine the association between marijuana use and undetectable viral load, and to assess the impact of antiretroviral (ART) medication adherence on this outcome. Methods: We used data from the Florida Medical Monitoring Project (2009–2010), a CDC-sponsored study from a random sample of persons receiving HIV care in Florida. Marijuana use was characterized as any (past year) vs. none; undetectable viral load (200 copies/mL) was determined by chart abstraction. Multivariable logistic regression was used to determine the association between marijuana use and undetectable viral load while adjusting for demographic factors, depression, other substance use, and ART adherence (95% or more). Results: Of the overall sample (n = 803), 76% (n = 528) had an undetectable viral load, 22% (n = 173) reported any marijuana use in the past 12 months, including 7.7% (n = 61) with daily use. Among those currently on ART (n = 628), marijuana users were less likely to achieve an undetectable viral load (72% vs. 83%, p = 0.018). In multivariable analysis, marijuana use was associated with a significantly decreased likelihood of having an undetectable viral load (OR: 0.57, 95% CI: 0.38–0.88). When adjusting for ART adherence, marijuana users remained less likely to have an undetectable viral load (OR: 0.65, 95% CI: 0.40–1.05), although the result was not statistically significant. Conclusions: Marijuana use was relatively common in this sample of persons with HIV and was associated with a reduced likelihood of having an undetectable viral load. This relationship appeared to be partially, but not completely, related to nonadherence to ART. Financial support: Research was supported in part by NIH grant AAU2402002. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.1046 Impact of adolescent marijuana use on emotion processing: An fMRI study Lora M. Cope ∗ , Jillian Hardee, Meghan E. Martz, Robert Zucker, Mary Heitzeg University of Michigan, Ann Arbor, MI, United States Aims: Marijuana is the most commonly used illicit drug in the U.S. Evidence exists for a potentially causal link between adolescent marijuana use and mood disorders later in life. Thus, the aim of this study was to examine associations among early marijuana use, emotion-related brain activity, and later emotional outcomes in young adults. Methods: Participants were forty 17–22 year old males and females from an ongoing fMRI longitudinal study. They were