Altreos Research Partners, Inc.
PUBLISHED Journal Articles
Abuse Liability and Addiction Research
Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62.
Zou S, Funk D, Shram MJ, Lê AD. Effects of stressors on the reinforcing efficacy of nicotine in adolescent and adult rats. Psychophamacol, 2013 epub ahead of print.
Romach MK, Schoedel KA, Sellers EM. Update on tamper-resistant drug formulations.
Drug Alcohol Depend. 2013 Jun 1;130(1-3):13-23.
Schoedel KA, Rolleri, RL, Faulknor JY, Pixton GC, Chen N, Bass A, Sommerville KW, Sellers E. Assessing subjective and physiological effects following intranasal administration of a new formulation of immediate release oxycodone HCI (OxectaTM) tablets in nondependent recreational opioid users. J Opioid Manag 2012 Sep-Oct:8(5):315-27.
Li S, Zou S, Coen K, Funk D, Shram MJ, Lê AD. Sex differences in yohimbine-induced increases in the reinforcing efficacy of nicotine in adolescent rats. Addict Biol. 2012 Jul 11. doi: 10.1111/j.1369-1600.2012.00473.x.
Schoedel KA, Addy C, Chakraborty B, Rosko K, Dunbar S, Maes A, Chen N, Stoch SA, Wagner J, Chodakewitz J, Sellers EM. Human abuse potential and cognitive effects of taranabant, a cannabinoid 1 receptor inverse agonist: A randomized, double-blind, placebo- and active-controlled, crossover study in recreational polydrug users. Clin Psychopharmacol. 2012 Aug;32(4):492-502.
Schoedel KA, Chen N, Hillard A, White L, Stott C, Russo E, Wright S, Guy G, Romach MK, Sellers EM. A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use. Hum Psychopharmacol. 2011 Jun 13. doi: 10.1002/hup.1196.
Schoedel KA, McMorn S, Zerbe K, Chakraborty B, Potts SL, Sellers EM. Positive and negative subjective effects of extended-release oxymorphone versus controlled-release oxycodone. J Opioid Manag. 2011;7(3):179-92.
Shram MJ, Schoedel KA, Bartlett C, Shazer RL, Anderson CM, Sellers EM. Evaluation of the abuse potential of lorcaserin, a serotonin 2C (5-HT(2C)) receptor agonist, in recreational polydrug users. Clin Pharmacol Ther. 2011 May;89(5):683-92.
Shram MJ, Sellers EM, Romach MK. Oral ketamine as a positive control in human abuse potential studies. Drug Alcohol Depend. 2011 Apr 1;114(2-3):185-93.
Schoedel KA, Meier D, Chakraborty B, Manniche PM, Sellers EM. Subjective and objective effects of the novel triple reuptake inhibitor tesofensine in recreational stimulant users. Clin Pharmacol Ther. 2010 Jul;88(1):69-78.
Mansbach RS, Schoedel KA, Kittrelle JP, Sellers EM. The role of adverse events and related safety data in the pre-market evaluation of drug abuse potential. Drug Alcohol Depend. 2010 Dec 1;112(3):173-7.
Shram MJ, Sathyan G, Khanna S, Tudor IC, Nath R, Thipphawong J, Sellers EM. Evaluation of the abuse potential of extended release hydromorphone versus immediate release hydromorphone. J Clin Psychopharmacol 2010; 30(1): 25-33.
Shram MJ, Lê AD. Adolescent male Wistar rats are more responsive than adult rats to the conditioned rewarding effects of intravenously administered nicotine in the place conditioning procedure. Behav Brain Res. 2010 Jan 20;206(2):240-4.
Schoedel KA; Sellers EM: Assessing abuse liability during drug development: Changing standards and expectation. Clin Pharmacol Ther 2008; 83(4): 622-626.
Shram MJ, Siu EC, Li Z, Tyndale RF, Lê AD. Interactions between age and the aversive effects of nicotine withdrawal under mecamylamine-precipitated and spontaneous conditions in male Wistar rats. Psychopharmacology (Berl). 2008 Jun;198(2):181-90.
Shram MJ, Funk D, Li Z, Lê AD. Nicotine self-administration, extinction responding and reinstatement in adolescent and adult male rats: evidence against a biological vulnerability to nicotine addiction during adolescence. Neuropsychopharmacology. 2008 Mar;33(4):739-48.
Shram MJ, Li Z, Lê AD. Age differences in the spontaneous acquisition of nicotine self-administration in male Wistar and Long-Evans rats. Psychopharmacology (Berl). 2008 Mar;197(1):45-58.
Parasrampuria DA, Schoedel KA, Schuller R, Gu J, Ciccone P, Silber SA, Sellers EM. Assessment of pharmacokinetics and pharmacodynamic effects related to abuse potential of a unique oral osmotic-controlled extended-release methylphenidate formulation in humans. J Clin Pharmacol 2007; 47(12): 1476-1488.
Parasrampuria DA, Schoedel K, Schuller R, Silber SA, Ciccone PE, Gu J, Sellers EM. Do formulation differences alter abuse liability of methylphenidate: A placebo-controlled, randomized, double blind, crossover study in recreational drug users. J Clin Psychopharmacol 2007; 27(5): 459-467.
Shram MJ, Funk D, Li Z, Lê AD. Acute nicotine enhances c-fos mRNA expression differentially in reward-related substrates of adolescent and adult rat brain. Neurosci Lett. 2007 May 18;418(3):286-91.
Wall TL, Schoedel KA, Ring HZ, Luczak SE, Katsuyoshi DM, Tyndale RF. Differences in pharmacogenetics of nicotine and alcohol metabolism: review and recommendations for future research. Nicotine Tob Res. 2007 Sep;9 Suppl 3:S459-74. Review.
Shram MJ, Funk D, Li Z, Lê AD. Periadolescent and adult rats respond differently in tests measuring the rewarding and aversive effects of nicotine.
Psychopharmacology (Berl). 2006 Jun;186(2):201-8.
Lê AD, Li Z, Funk D, Shram M, Li TK, Shaham Y. Increased vulnerability to nicotine self-administration and relapse in alcohol-naive offspring of rats selectively bred for high alcohol intake. J Neurosci. 2006 Feb 8;26(6):1872-9.
Schoedel KA, Hoffmann EB, Rao Y, Sellers EM, Tyndale RF. Ethnic variation in CYP2A6 and association of genetically slow nicotine metabolism and smoking in adult Caucasians. Pharmacogenetics. 2004 Sep;14(9):615-26.
Shram MJ, Bahroos M, Beleskey JI, Tampakeras M, Lê AD, Tomkins DM. Motor impairing effects of ethanol and diazepam in rats selectively bred for high and low ethanol consumption in a limited-access paradigm. Alcohol Clin Exp Res. 2004 Dec;28(12):1814-21.
Schoedel KA, Tyndale RF. Induction of nicotine-metabolizing CYP2B1 by ethanol and ethanol-metabolizing CYP2E1 by nicotine: summary and implications. Biochim Biophys Acta. 2003 Feb 17;1619(3):283-90. Review.
Schoedel KA, Sellers EM, Palmour R, Tyndale RF. Down-regulation of hepatic nicotine metabolism and a CYP2A6-like enzyme in African green monkeys after long-term nicotine administration. Mol Pharmacology 2003; 63: 96-104 (CSCP 2003 publication award recipient).
Schoedel KA, Sellers EM, Tyndale RF. Induction of CYP2B1/2 and nicotine metabolism by ethanol in rat liver but not rat brain. Biochem Pharmacol 2001; 62: 1025-1036.
Clinical Pharmacology, Neuropharmacology and CNS Drug Development
Schoedel KA, Geoffroy P. CNS drug liabilities in early phase clinical trials, May 2013.
Schoedel KA, Harrison SJ. Subjective and physiological effects of oromucosal sprays containing cannabinoids (nabiximols): potentials and limitations for psychosis research. Curr Pharm Des. 2012;18(32):5008-14. Review.
Pope LE, Schoedel KA, Bartlett C, Sellers EM. A study of potential pharmacokinetic and pharmacodynamic interactions between dextromethorphan/quinidine and memantine in healthy volunteers. Clin Drug Investig. 2012 Jun 19. doi: 10.2165/11633850-000000000-00000.
Shram MJ, Quinn AM, Chen N, Faulknor J, Luong D, Sellers EM, Endrenyi L. Differences in the in vitro and in vivo pharmacokinetic profiles of once-daily modified-release methylphenidate formulations in Canada: Examination of current bioequivalence criteria. Clin Ther. 2012 Apr 16.
Schoedel KA, Pope LE, Sellers EM. Randomized open-label drug-drug interaction trial of dextromethorphan/quinidine and paroxetine in healthy volunteers. Clin Drug Investig. 2012 Jan 25. doi: 10.2165/11599870-000000000-00000.
Nadkarni NK, Levy-Cooperman N, Black SE. Functional correlates of instrumental activities of daily living in mild Alzheimer's disease. Neurobiol Aging. 2012 Jan;33(1):53-60.
McMorn S, Schoedel KA, Sellers EM. Effects of low-dose opioids on cognitive dysfunction. J Clin Oncol. 2011 Nov 10;29(32):4342-3.
Ramirez J, Gibson E, Quddus A, Lobaugh NJ, Feinstein A, Levine B, Scott CJ, Levy-Cooperman N, Gao FQ, Black SE. Lesion Explorer: a comprehensive segmentation and parcellation package to obtain regional volumetrics for subcortical hyperintensities and intracranial tissue. Neuroimage. 2011 Jan 15;54(2):963-73.
Schoedel KA, McMorn S, Chakraborty B, Zerbe K, Sellers EM. Reduced cognitive and psychomotor impairment with extended-release oxymorphone versus controlled-release oxycodone. Pain Physician. 2010 Dec;13(6):561-73.
Levy-Cooperman N, Burhan AM, Rafi-Tari S, Kusano M, Ramirez J, Caldwell C, Black SE.
Frontal lobe hypoperfusion and depressive symptoms in Alzheimer disease. J Psychiatry Neurosci. 2008 May;33(3):218-26.
Levy-Cooperman N, Ramirez J, Lobaugh NJ, Black SE. Misclassified tissue volumes in Alzheimer disease patients with white matter hyperintensities: importance of lesion segmentation procedures for volumetric analysis.
Stroke. 2008 Apr;39(4):1134-41.
Levy-Cooperman N, Lobaugh NJ, Caldwell C, Gao F, Black SE. Subcortical hyperintensities in Alzheimer's disease: no clear relationship with executive function and frontal perfusion on SPECT. Dement Geriatr Cogn Disord. 2007;24(5):380-8.
Hampson E, Finestone JM, Levy N. Menstrual cycle effects on perceptual closure mediate changes in performance on a fragmented objects test of implicit memory. Brain and Cognition 2005;57(2):107-10.
Dempsey D, Tutka P, Jacob P 3rd, Allen F, Schoedel KA, Tyndale RF, Benowitz NL.
Nicotine metabolite ratio as an index of cytochrome P450 2A6 metabolic activity. Clin Pharmacol Ther. 2004 Jul;76(1):64-72.
Publications In Press
Harris SC, Perrino PJ, Sellers EM, Smith I, Shram M, Bartlett C, Colucci SV. Abuse potential, pharmacokinetics, pharmacodynamics and safety of intranasally administered crushed oxycodone HCl tamper-resistant controlled-release in recreational opioid users. In press at J Clin Pharmacology.
Book chapters
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Little HJ, McKinzie DL, Setnik B, Shram MJ, Sellers EM. Pharmacotherapy of dependence: Improving translation from the bench to the clinic, Chapter 5. In: Animal and Translational Models for CNS Drug Discovery, Volume 3: Reward Deficit Disorders. McArthur R, Borsini F (eds.), Academic Press, Burlington, MA, 2008. pp. 91 – 106
Romach MK, Schoedel KA, Sellers EM. Drugs used for anxiety, stress disorders, and insomnia in principles of medical pharmacology, 7th Edition (2007), Kalant, H., Grant, D.M. and J. Mitchell (eds.). Elsevier Canada, Toronto.
Sellers EM, Schoedel KA, Romach MK. Drug interactions. Principles of Medical Pharmacology, 7th Edition (2007), Kalant, H., Grant, D.M. and J. Mitchell (eds.). Elsevier Canada, Toronto.
Conferences/abstracts (Presented or Accepted; FROM 2005)
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Abuse Liability and Addiction Research
Levy-Cooperman N, McIntyre G, Bonifacio L, Davenport M, Covingto P, Dove S,
Almenoff J, Chakraborty B, Schoedel K, McDonnell M, Sellers EM.Lack of subjective abuse-related effects of intranasal eluxadoline: a novel mu-delta opiate modulator for oral use in IBSd. Accepted for the American College of Neuropsychopharmacology Meeting, December 8-12, 2013, Hollywood, FL.
Levy-Cooperman N, Chakraborty B, Hopyan T, Cheng H, Blum D, Schoedel KA. Abuse potential assessment of eslicarbazepine acetate in healthy male and female recreational sedative users. Accepted for the American Epilepsy Society meeting, December 6-10, 2013, Washington, DC.
Schoedel KA. Interpretation of Human Abuse Potential Studies and Clinically Important Responses to ADFs. Abuse-Deterrent Formulation Science Meeting, Sep 30-Oct1, 2013, Bethesda, MD. [Invited oral presentation]
Schoedel KA. Summary and Discussion Points for Pharmacokinetic (Category2) & Clinical Abuse Potential Studies (Category3). Abuse-Deterrent Formulation Science Meeting, Sep 30-Oct1, 2013, Bethesda, MD. [Invited oral presentation]
Shram MJ. PK/PD Analysis in the Assessment of Abuse Deterrence. Abuse-Deterrent Formulation Science Meeting, Sep 30-Oct1, 2013, Bethesda, MD. [Invited oral presentation]
Levy-Cooperman N. Structuring the Submission of Abuse Deterrence Data and Formulating the ADF Label. ADF Science Meeting, Sep 30-Oct1, 2013, Bethesda, MD. [Invited oral presentation]
Wang Y, Perrino P, Schoedel KA, Geoffroy P, Colucci SV, Harris SC. Abuse Potential of Chewed or Intact Oxycodone/Naloxone (OXN) Tablets in Methadone-Stabilized, Opioid-Dependent Subjects when Administered Orally. Pain Week, 2013, Las Vegas, NV.
Harris SC, Perrino PJ, Shram M, Bartlett CB, Colucci SV, Wang Y. Abuse Potential of Oxycodone/Naloxone (OXN) Tablets Administered Intranasally in Non-Dependent Recreational Drug Users with Moderate Opioid Experience. Pain Week, 2013, Las Vegas, NV.
Colucci SV, Perrino PJ, Shram M, Bartlett C, Wang Y, Harris SC. Abuse Potential of Oxycodone/Naloxone Solution Administered Intravenously in Non-Dependent Recreational Drug Users with Moderate Opioid Experience. Pain Week, 2013, Las Vegas, NV.
Perrino PJ, Colucci CV, Shram M, Bartlett C, Sellers EM, Wang Y, Harris SC. Relative Attractiveness of Oxycodone/Naloxone (OXN): Comparative Assessment of Tampering Potential and Recreational Drug User Preferences for Different Opioid Formulations. Pain Week, 2013, Las Vegas, NV.
Levy-Cooperman N, Mills C, Shram MJ, Schoedel KA. Reducing Subject Burden: Identifying Critical Measures in Human Abuse Potential Studies using Factor Analysis. College on Problems of Drug Dependence, June 16-20, 2013, San Diego, CA.
Levy-Cooperman, N. Clinical assessment of abuse deterrent formulations. College on Problems of Drug Dependence, June 16-20, 2013, San Diego, CA. [Invited oral presentation]
Schoedel KA, Sokolowska M. Assessment of abuse deterrent and tamper resistant technologies part II: New directions. Workshop at College on Problems of Drug Dependence, June 16-20, 2013, San Diego, CA. [Workshop Chair]
Levy-Cooperman N, Mills C, Shram MJ, Schoedel KA. Reducing subject burden: Identifying critical measures in human abuse potential studies using factor analysis. College on Problems of Drug Dependence, June 16-20, 2013, San Diego, CA.
Schoedel KA, Setnik B, Roland C, Pixton G, Shram MJ, Levy-Cooperman N. Review of human abuse potential study methodology for abuse-deterrent formulations (ADFs). College on Problems of Drug Dependence, June 16-20, 2013, San Diego, CA.
Levy-Cooperman N, Schoedel KA. Opioid-related adverse events in clinical trials – Indicators for abuse liability. American Pain Society 32nd Annual Scientific Meeting, May 8-11, 2013, New Orleans, LA.
Turncliff RZ, Silverman B, Du Y, Vince B, Sellers EM, Chen N, Shram M, Todtenkopf MS, Ehrich E. ALKS 5461, a Novel Opioid Receptor Modulator, Reduces the Subjective Effects of Cocaine and was Safe and Well Tolerated during Concurrent Cocaine Administration. 51st Annual Meeting of the American College of Neuropsychopharmacology, December 2-6, 2012, Hollywood, FL.
Schoedel KA, Sokolowska M. Assessment of abuse deterrent and tamper resistant technologies: from the bench-top to the users. Workshop at College on Problems of Drug Dependence, June 9-14, 2012, Palm Springs, CA. [Workshop Chair]
Shram MJ. A focus on the clinical assessment of abuse-deterrent formulations. College on Problems of Drug Dependence, June 9-14, 2012, Palm Springs, CA. [Invited oral presentation]
Shram MJ, Levy-Cooperman N, Chen N, Mills C, Bartlett C, Setnik B, van der Graaf P, Ratcliffe S, Schoedel KA. Sensitivity and performance of derived parameters from human abuse potential studies. College on Problems of Drug Dependence, June 9-14, 2012, Palm Springs, CA.
Schoedel KA, Shram M, Levy-Cooperman N, Chen N, Mills C, Bartlett C, Setnik B, van der Graaf P, Ratcliffe S. Defining clinically important differences in subjective abuse potential measures. College on Problems of Drug Dependence, June 9-14, 2012, Palm Springs, CA.
Setnik B, Goli V, Levy-Cooperman N, Smith I. Self reports of prescription opioid misuse, abuse and diversion in a sample of recreational opioid users. Canadian Pain Society Annual Conference, May 23-26, 2012, Whistler, BC.