Current FDA regulatory guidance on the conduct of drug discrimination studies for NDA review: Does the scientific literature support recent recommendations?

Amrick, 1987, A comparison of diazepam stimuli in aged and adult rats, Psychopharmacology (Berl.), 93, 292, 10.1007/BF00187245 Ator, 1989, Differential generalization to pentobarbital in rats trained to discriminate lorazepam, chlordiazepoxide, diazepam, or triazolam, Psychopharmacology (Berl.), 98, 20, 10.1007/BF00442001 Benvenga, 1991, The discriminative stimulus effects of MK-801 in ketamine trained rats, Pharmcol. Biochem. Behav., 38, 211, 10.1016/0091-3057(91)90613-7 Bertalmio, 1982, A procedure for rapid evaluation of the discriminative stimulus effects of drugs, J. Pharmacol. Method., 7, 288, 10.1016/0160-5402(82)90082-1 Catania, 1971, Discriminative stimulus functions of drugs: interpretation, 149 Colpaert, 1982 Colpaert, 1975, Investigations on drug produced and subjectively experienced discriminative stimuli. 2. Loperamide, an antidiarrheal devoid of narcotic cue producing actions, Life Sci., 16, 717, 10.1016/0024-3205(75)90348-3 Colpaert, 1978, Discriminative stimulus properties of cocaine and d-amphetamine and antagonism by haloperidol: a comparative study, Neuropharmacology, 17, 937, 10.1016/0028-3908(78)90135-1 Colpaert, 1978, Narcotic cue, narcotic analgesia, and the tolerance problem: the regulation of sensitivity to drug cues and to pain by an internal cue processing model, 301 Colpaert, 2011, Drug discrimination: a perspective, 483 Craft, 1988, Cue properties of oral and transdermal nicotine in the rat, Psychopharmacology, 96, 281, 10.1007/BF00216050 Emmett-Oglesby, 1987, Opioid modulation of the discriminative stimulus produced by pentylenetetrazol, Psychopharmacology (Berl.), 92, 313, 10.1007/BF00210836 European Monitoring Centre for Drugs and Drug Addiction, 2009. Risk Assessment Of New Psychoactive Substances. Operating Guidelines. http://www.emcdda.europa.eu/attachements.cfm/att_100979_EN_RiskGuidelines2010.pdf. European Medicines Agency (EMeA), 2006. Guideline on the Non-clinical Investigation of the Dependence Potential of Medicinal Products. Committee for Medicinal Products for Human Use (EMEA/CHM /SWP/94227/2004), London. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003360.pdf (accessed 18.04.14.) 1979, The Experimental Analysis of Behavior: A Biological Perspective Fiorella, 1995, The time-dependent effects of R(−)-w, 5-dimethoxy-4-methamphetamine (DOM): implications for drug-induced stimulus control as a method for the study of hallucinogenic agents, Psychopharmacology (Berl.), 119, 239, 10.1007/BF02246166 Garcha, 1985, Midazolam cue in rats: generalization tests with anxiolytic and other drugs, Psychopharmacology (Berl.), 87, 233, 10.1007/BF00431814 Gatch, 2009, Comparison of the discriminative stimulus effects of dimethyltryptamine with different classes of psychoactive compounds in rats, Psychopharmacology (Berl.), 204, 715, 10.1007/s00213-009-1501-z Gauvin, 1989, Continuous or quantal data in drug discrimination experiments is a measurement issue not a reinforcement issue, Psychopharmacology, 113, 297, 10.1007/BF02245197 Gauvin, 1987, The drug discrimination procedure: a microanalysis of the qualitative properties of quantal responses, Psychol. Rec., 37, 167, 10.1007/BF03394979 Gauvin, 1989, Caffeine-phenylethylamine combinations mimic the cocaine discriminative cue, Life Sci., 44, 67, 10.1016/0024-3205(89)90219-1 Gauvin, 1990, Potentiation of cocaine's discriminative effects by caffeine: a time-effect analysis, Pharmacol. Biochem. Behav., 36, 195, 10.1016/0091-3057(90)90149-C Gauvin, 1992, The discriminative stimulus properties of acute ethanol withdrawal (hangover) in rats, Alcohol. Clin. Exp. Res., 16, 336, 10.1111/j.1530-0277.1992.tb01387.x Gauvin, 1993, The discriminative stimulus properties of legal, over-the-counter stimulants administered singly and in binary and ternary combinations, Psychopharmacology (Berl.), 110, 309, 10.1007/BF02251286 Gauvin, 1995, Cross-generalization between cocaine cue and two antihistamines, Eur. J. Pharmacol., 294, 281, 10.1016/0014-2999(95)00550-1 Gauvin, 1996, Selective attention to elements of a morphine stimulus idiosyncratic stimulation additivity of incidental cues, Exp. Clin. Psychopharm., 4, 379, 10.1037/1064-1297.4.4.379 Gauvin, 1997, Physiological and subjective effects of acute cocaine withdrawal (crash) in rats, Pharmacol. Biochem. Behav., 57, 923, 10.1016/S0091-3057(97)00262-1 Gauvin, 1997, Cumulative versus acute dose-response procedures produce differential BAC and behavioral functions for ETOH, Pharmacol. Biochem. Behav., 57, 397, 10.1016/S0091-3057(96)00473-X Gauvin, 1998, The stimulus properties of two common over-the-counter drug mixtures: dextromethorphan+ephedrine and dextromethorphan+diphenhydramine, J. Psychopharm.¬cology., 12, 84, 10.1177/026988119801200111 Gianutsos, 1975, Effects of loperamide, haloperidol and methadone in rats trained to discriminate morphine from saline, Psychopharmacolgia, 41, 267, 10.1007/BF00428935 Glennon, 2000, (+)Amphetamine-stimulus generalization to an herbal ephedrine product, Pharmacol. Biochem. Behav., 65, 655, 10.1016/S0091-3057(99)00238-5 Glennon, 2011 Glennon, 1986, Discriminative stimulus properties of the serotonergic agent 1-(2,5-dimethoxy-4-iodophenyl)-2-aminopropane (DOI), Life Sci., 39, 10.1016/0024-3205(86)90461-3 Graham, 1993, Cocaine-like discriminative stimulus effects of procaine, dimethocaine and lidocaine in rats, Psychopharmacology (Berl.), 110, 287, 10.1007/BF02251283 Grech, 1993, Pentobarbital-like discriminative stimulus effects of direct GABA agonists in rats, Psychopharmacology (Berl.), 110, 295, 10.1007/BF02251284 Guttman, 1956, Discriminability and stimulus generalization, J. Exp. Psychol., 51, 79, 10.1037/h0046219 Heal, 2013, A preclinical evaluation of the discriminative and reinforcing properties of lisdexamfetamine in comparison to d-amfetamine, methylphenidate, and modafinil, Neuropharmacology, 73, 348, 10.1016/j.neuropharm.2013.05.021 Herrnstein, 1970, On the law of effect, J. Exp. Anal. Behav., 13, 243, 10.1901/jeab.1970.13-243 Holloway, 1989, Comments on method and theory in drug discrimination: a potpourri of problems perplexities, and possibilities, Drug Dev. Res., 16, 195, 10.1002/ddr.430160213 Järbe, 1982, A conceptualization of drug discrimination learning, 327 Jackson, 1996, N-Methyl-d-aspartate (NMDA) and α-amino-3-hydroxy-5-methyl-4-isoxaloleproprionate (AMPA) glutamate-receptor antagonists have different interactions with the discriminative stimuli of abuse drugs, Psychopharmacology (Berl.), 128, 320, 10.1007/s002130050140 Kaempf, 1987, A comparison of testing procedures on the discriminative morphine stimulus, Psychopharmacology (Berl.), 91, 56, 10.1007/BF00690927 Kallman, 1978, Drug discrimination paradigms: problems of tolerance and behavioral disruption, 253 Keller, 1950 Kuhn, 1977, Discriminative stimulus properties of halluciongens: behavioral assay of drug action, 137 Mackintosh, 1977, Stimulus control: attentional factors, 481 Mariathasan, 1992, Drug discrimination studies in rats with caffeine and phenylpropanolamine admistered separately and as mixtures, Psychopharmacology (Berl.), 109, 99, 10.1007/BF02245486 McMillan, 2000, Drug discrimination in rats under concurrent variable-interval variable-interval schedules, J. Exp. Anal. Behav., 73, 103, 10.1901/jeab.2000.73-103 McMillan, 1999, Drug discrimination under a concurrent fixed-ratio fixed-ratio schedule, J. Exp. Anal. Behav., 72, 187, 10.1901/jeab.1999.72-187 McMillan, 2000, Drug discrimination under two concurrent fixed-interval fixed-interval schedules, J. Exp. Anal. Behav., 74, 55, 10.1901/jeab.2000.74-55 McMillan, 2002, Drug discrimination under concurrent variable-ratio variable-ratio schedules, J. Exp. Anal. Behav., 77, 91, 10.1901/jeab.2002.77-91 McMillan, 1987, On the stability of phencyclidine discrimination in the pigeon, Alcohol Drug Res., 7, 147 Migler, 1964, Effects of averaging data during stimulus generalization, J. Exp. Anal. Behav., 12, 81, 10.1901/jeab.1969.12-81 National Research Council (NRC), 1983, Committee on the institutional means for assessment of risks to public health Nierenberg, 1990, Drug discrimination in rats successively trained to discriminate diazepam and pentobarbital, Pharmacol. Biochem. Behav., 35, 405, 10.1016/0091-3057(90)90177-J Personal/Corporate/FDA Communication, January, 2016. Comments on Abuse Liability Protocols submitted to the CSS staff at CDER in FDA for pre-study review, from Terese Wheelous, FDA; MPI Research Sponsor Number 2409. Personal/Corporate/FDA Communication, May 2016. Comments on Abuse Liability Protocols submitted to the CSS staff at CDER in FDA for pre-study review from Terese Wheelous; MPI Research Sponsor Number 2378. Picker, 1990, Discriminative stimulus properties of U50,488 and morphine: effects of training dose on stimulus substitution patterns produced by mu and kappa opioid agonists, J. Pharmacol. Exp. Ther., 254, 13 Pratt, 1983, Discriminative stimulus properties of nicotine: further evidence for mediation at a cholinergic receptor, Psychopharmacology (Berl.), 81, 54, 10.1007/BF00439274 Prelec, 1982, Matching, maximizing, and the hyperbolic reinforcing feedback function, Psychol. Rev., 89, 189, 10.1037/0033-295X.89.3.189 Quisenberry, 2013, Combined effects of modafinil and d-amphetamine in male Sprague-Dawley rats trained to discriminate d-amphetamine, Pharmacol. Biochem. Behav., 110, 208, 10.1016/j.pbb.2013.07.011 Ray, 1970, Reinforcement and stimulus control, 187 Rilling, 1977, Stimulus Control and inhibitory processes, 432 Rosen, 1986, Disriminative stimulus properties of amphetamine and other stimulant in lead-exposes and normal rats, Pharmacol. Biochem. Behav., 24, 211, 10.1016/0091-3057(86)90340-0 Sannerud, 1993, Tolerance to the discriminative stimulus effects of midazolam: evidence for environmental modification and dose fading, Behav. Pharmacol., 4, 125, 10.1097/00008877-199304000-00005 Sannerud, 1987, Environmental modification of tolerance to morphine discriminative stimulus properties in rats, Psychopharmacology (Berl.), 93, 59, 10.1007/BF02439587 Sannerud, 1991, Comparison of the discriminative stimulus effects of midazolam after intracranial and peripheral administration in the rat, Life Sci., 49, 261, 10.1016/0024-3205(91)90012-Z Sannerud, 1993, Tolerance to the behavioral effects of chlordiazepoxide: Pharmacological and biochemical selectivity, Pharmacol. Exper. Ther., 267, 1311 Shannon, 1976, Evaluation of the discriminative effects of morphine in the rat, J. Pharmacol. Exp. Ther., 198, 54 Shannon, 1977, Further evaluation of the discriminative effects of morphine in the rat, J. Pharmacol. Exp. Ther., 201, 55 Sidman, 1980, A note on the measurement of conditional discrimination, J. Exp. Anal. Behav., 33, 285, 10.1901/jeab.1980.33-285 Stoddard, 1967, The effects of errors n children’s performance of a circle-elipse discrimination, J. Exp. Anal. Behav., 10, 261, 10.1901/jeab.1967.10-261 Stoddard, 1971, The removal and restoration of stimulus control, J. Exp. Anal. Behav., 16, 143, 10.1901/jeab.1971.16-143 Stolerman, 1991, Measures of stimulus generalization in drug discrimination experiments, Behav. Pharmacol., 2, 265, 10.1097/00008877-199109000-00003 Stolerman, 1993, Drug discrimination, 217 Tang, 1991, The discriminative stimulus effects of diazepam in rats at two training doses, J. Pharmacol. Exp. Ther., 258, 926 Thompson, 1968 U.S. Food and Drug Administration,; 2010. Guidance for Industry Assessment of Abuse Potential of Drugs, Draft Guidance. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm198650.pdf. U.S. Food and Drug Administration, 2013. Structure approach to benefit-risk assessment in drug regulatory decision-making: PDUFA implementation Plan. http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm329758.pdf. Wiley, 2002, Nicotine-like discriminative stimulus effects of bupropion in rats, Exp. Clin. Psychopharmacol., 10, 129, 10.1037/1064-1297.10.2.129 Wykoff, 1952, The role of observing responses in discrimination learning. Part I, Psychol. Rev., 59, 431, 10.1037/h0053932 Wykoff, 1959, Toward a quantitative theory of secondary reinforcement, Psychol. Rev., 66, 68, 10.1037/h0046882 Young, 1982, Differentiation of the behavioral responses produced by barbiturates and benzodiazepines by the benzodiazepine antagonist Ro 15-1788, 235 Young, 1998, Discriminative stimulus properties of (−)ephedrine, Pharmacol. Biochem. Behav., 60, 771, 10.1016/S0091-3057(98)00055-0 Young, 2002, Nicotine and bupropion share a similar discriminative stimulus effect, Eur. J. Pharmacol., 443, 113, 10.1016/S0014-2999(02)01554-6 Young, 1987, Effects of pyrazolopyridines and triazolopyridazine on the pentobarbital discriminative stimulus, Psychopharmacology (Berl.), 93, 494, 10.1007/BF00207241 Young, 1999, An examination of isomeric phenylpropanolamines in (−) ephedrine-trained rats, Drug Alcohol Depend., 57, 1, 10.1016/S0376-8716(99)00052-6 Zarcone, 2000, Drug discrimination: stimulus control during repeated testing in extinction, JEAB, 74, 283