Publications & Presentations

Selected Publications

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.

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.

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, 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.

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.

Schoedel KA; Sellers EM: Assessing abuse liability during drug development: Changing standards and expectation. Clin Pharmacol Ther 2008; 83(4): 622-626.

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.

Selected Conferences/Abstracts

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 IBS d. 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]

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]

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]

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.

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.

Schoedel KA. Human Subject abuse potential studies: validated scales and statistical and clinical assessments. Science of Abuse Liability Assessment, a Joint NIDA-FDA Public Workshop, November 10, 2011, Rockville, MD. [FDA invited oral presentation]

Schoedel KA, Frey J, Chakraborty B, Myroslava MK, Sellers EM. Receptor sub-type selectivity affects subjective and cognitive effects of GABA modulators in humans: A comparison of lorazepam and a novel GABAAα2/GABAAα3 selective modulator. College on Problems of Drug Dependence, June 21-25, 2011, Hollywood, FL [selected as an oral presentation].

Schoedel KA, Cronenberger C, Corrigan C, Fullerton T, Fang J, Martin N, Ryan N, Lopez R, Mordenti J, Smith I, Sellers EM. Drug abuse potential of dimebon: A randomized, double-blind, single-dose placebo- and active-controlled crossover study in healthy recreational polydrug users. American Society of Clinical Pharmacology and Therapeutics, March 2011, Dallas, TX.

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