Abuse liability assessment of tobacco products including potential reduced exposure products

Cancer Epidemiology Biomarkers and Prevention

Volumn 18, Issue 12, 2009, Pages 3241-3262

  Carter, Lawrence P ^a   Stitzer, Maxine L ^b   Henningfield, Jack E ^c   O'Connor, Rich J ^d   Cummings, K Michael ^d   Hatsukami, Dorothy K ^e  

^a UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c PINNEY ASSOCIATES   (United States)

^d ROSWELL PARK CANCER INSTITUTE   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NICOTINE;

ELECTROENCEPHALOGRAM; FILTER; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; NEUROIMAGING; POTENTIAL REDUCED EXPOSURE PRODUCT; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TOBACCO; TOBACCO DEPENDENCE; WITHDRAWAL SYNDROME;

BEHAVIOR, ADDICTIVE; CLINICAL TRIALS AS TOPIC; HUMANS; RISK ASSESSMENT; SMOKING CESSATION; TOBACCO; TOBACCO USE DISORDER;

EID: 73349083942     PISSN: 10559965     EISSN: None     Source Type: Journal    
DOI: 10.1158/1055-9965.EPI-09-0948     Document Type: Review

References (193)

1. U.S. Department of Health & Human Services. Reducing tobacco use: a report of the Surgeon General. Atlanta (GA): U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2000.
2. U.S. Department of Health & Human Services. The health consequences of smoking: a report of the Surgeon General. Atlanta (GA): U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2004.
3. Stratton K, Shetty P, Wallace R, Bondurant S, editors. Clearing the smoke: assessing the science base for tobacco harm reduction. Washington (DC): Institute of Medicine, National Academy Press; 2001.
4. Hatsukami D, Henningfield J, Kotlyar M. Harm reduction approaches to reducing tobacco-related mortality. Annu Rev Public Health 2004; 25:1-19.
5. Bonnie RJ, Stratton K, Wallace RB, editors. Ending the tobacco problem: a blueprint for the nation. Washington (DC): Institute of Medicine, National Academy Press; 2007.
6. World Health Organization. The scientific basis of tobacco product regulation: second report of a WHO Study Group. Report no. 978-92-4-120951-9. WHO technical report series, no. 951. Geneva: World Health Organization; 2008.
7. World Health Organization. The scientific basis of tobacco product regulation: report of a WHO Study Group. Technical report 945. Geneva: World Health Organization, Genevap; 2007.
8. U.S. Congress. Family Smoking Prevention and Tobacco Control Act. Public Law 111-31; One Hundred Eleventh Congess of the United States of America; Congress U.S. City: U.S. Government Printing Office; 2009. http://frwebgate. access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111-cong-public-laws&docid=f: publ031.111.pdf.
9. Schuster CR, Henningfield J. Conference on abuse liability assessment of CNS drugs. Drug Alcohol Depend 2003;70:S1-4.
10. Expert Panel. Abuse liability assessment of CNS drugs: conclusions, recommendations, and research priorities. Drug Alcohol Depend 2003;70:S107-14.
11. Grudzinskas C, Balster RL, Gorodetzky CW, et al. Impact of formulation on the abuse liability, safety and regulation of medications: the expert panel report. Drug Alcohol Depend 2006;83 Suppl 1:S77-82.
12. Carter LP, Griffiths RR. Principles of laboratory assessment of drug abuse liability and implications for clinical development. Drug Alcohol Depend 2009;105:S14-25.
13. Johanson CE, Balster RL, Henningfield JE, et al. Expert Panel Report. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system. Drug Alcohol Depend 2009;105:S65-71.
14. U.S. Department of Health & Human Services. The health consequences of smoking: nicotine and addiction. A report of the Surgeon General. DHHS publication no. (CDC) 88-8406. U.S. Department of Health & Human Services; 1988.
15. U.S. Department of Health and Human Services. The health consequences of using smokeless tobacco: a report of the Advisory Committee to the Surgeon General. NIH publication no. 86-2874. DHHS publication no. 86-2874. Bethesda (MD): U.S. Department of Health and Human Services, Public Health Service; 1986 (April).
16. Food and Drug Administration. Regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to protect children and adolescents; proposed rule analysis regarding FDA's jurisdiction over nicotine-containing cigarettes and smokeless tobacco products; notice. Fed Regist 1995;60:41314-792.
17. Food and Drug Administration. Regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents; final rule. Fed Regist 1996;61:44396-5318.
18. National Institute on Drug Abuse. Drug abuse and drug abuse research. Washington (DC): U.S. Government Printing Office; 1984.
19. Burns DM, Dybing E, Gray N, et al. Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg proposal. Tob Control 2008;17:132-41.
20. World Health Organization. Scientific Advisory Committee on Tobacco Product Regulation (SACTob) Recommendation on Tobacco Product Ingredients and Emissions. 2003. http://www.who.int/tobacco/ sactob/recommendations/en/ ingredients-en.pdf.
21. Balster RL, Bigelow GE. Guidelines and methodological reviews concerning drug abuse liability assessment. Drug Alcohol Depend 2003;70:S13-40.
22. Henningfield JE, Keenan R. Nicotine delivery kinetics and abuse liability. J Consult Clin Psychol 1993;61:743-50.
23. Stitzer ML, de Wit H. Abuse liability of nicotine. In: Benowitz NL, editor. Society for Research on Nicotine and Tobacco. Nicotine safety and toxicity. New York: Oxford University Press; 1998, p. 119-31.
24. Schuh KJ, Schuh LM, Henningfield JE, Stitzer ML. Nicotine nasal spray and vapor inhaler: abuse liability assessment. Psychopharmacology (Berl) 1997;130:352-61.
25. Houtsmuller EJ, Fant RV, Eissenberg TE, Henningfield JE, Stitzer ML. Flavor improvement does not increase abuse liability of nicotine chewing gum. Pharmacol Biochem Behav 2002;72:559-68.
26. Fant RV, Henningfield JE, Nelson RA, Pickworth WB. Pharmacokinetics and pharmacodynamics of moist snuff in humans. Tob Control 1999; 8:387-92.
27. Balster RL. Drug abuse potential evaluation in animals. Br J Addict 1991;86:1549-58.
28. World Health Organization. Advancing knowledge on regulating tobacco products (monograph). Geneva, Switzerland: World Health Organization; 2001.
29. Wayne GF, Connolly GN, Henningfield JE. Assessing internal tobacco industry knowledge of the neurobiology of tobacco dependence. Nicotine Tob Res 2004;6:927-40.
30. Henningfield JE, Rose CA, Zeller M. Tobacco industry litigation position on addiction: continued dependence on past views. Tob Control 2006;15 Suppl 4:iv27-36.
31. deWit H, Zacny J. Abuse potentials of nicotine replacement therapies. CNS Drugs 1995;4:456-68.
32. Royal College of Physicians. Harmreduction in nicotine addiction. Helping people who can't quit. London: Royal College of Physicians; 2007.
33. Buchhalter AR, Fant RV, Henningfield JE. Nicotine. In: Sibley DR, Hanin I, Kuhar M, Skolnick P, editors. Handbook of contemporary neuropharmacology. Hoboken (NJ): John Wiley & Sons; 2007. p. 535-66.
34. Henningfield JE, Pankow J, Garrett B. Ammonia and other chemical base tobacco additives and cigarette nicotine delivery: issues and research needs. Nicotine Tob Res 2004;6:199-205.
35. Chen C, Pankow JF. Gas/particle partitioning of two acid-base active compounds in mainstream tobacco smoke: nicotine and ammonia. J Agric Food Chem 2009;57:2678-90.
36. Slade J, Henningfield JE. Tobacco product regulation: context and issues. Food Drug Law J 1998;53:43-74.
37. Belluzzi JD, Wang R, Leslie FM. Acetaldehyde enhances acquisition of nicotine self-administration in adolescent rats. Neuropsychopharmacology 2005;30:705-12.
38. Talhout R, Opperhuizen A, van Amsterdam JG. Role of acetaldehyde in tobacco smoke addiction. Eur Neuropsychopharmacol 2007;17: 627-36.
39. Crooks PA, Dwoskin LP. Contribution of CNS nicotine metabolites to the neuropharmacological effects of nicotine and tobacco smoking. Biochem Pharmacol 1997;54:743-53.
40. Green TA, Phillips SB, Crooks PA, Dwoskin LP, Bardo MT. Nornicotine pretreatment decreases intravenous nicotine self-administration in rats. Psychopharmacology 2000;152:289-94.
41. Bardo MT, Green TA, Crooks PA, Dwoskin LP. Nornicotine is selfadministered intravenously by rats. Psychopharmacology (Berl) 1999;146:290-6.
42. Fowler JS, Logan J, Wang G-J, Volkow ND. Monoamine oxidase and cigarette smoking. Neurotoxicology 2003;24:75-82.
43. Fowler JS, Volkow ND, Wang G-J, et al. Inhibition of monoamine oxidase B in the brains of smokers. Nature 1996;379:733-6.
44. DeNoble VJ, Mele PC. Intravenous nicotine self-administration in rats: effects of mecamylamine, hexamethonium and naloxone. Psychopharmacology 2006;184:266-72.
45. Ashley DL, Pankow JF, Tavakoli AD, Watson CH. Approaches, challenges, and experience in assessing free nicotine. Handb Exp Pharmacol 2009:437-56.
46. Watson CH, Trommel JS, Ashley DL. Solid-phase microextractionbased approach to determine free-base nicotine in trapped mainstream cigarette smoke total particulate matter. J Agric Food Chem 2004;52:7240-5.
47. Ferris Wayne G, Connolly GN, Henningfield JE. Brand differences of free-base nicotine delivery in cigarette smoke: the view of the tobacco industry documents. Tob Control 2006;15:189-98.
48. Kozlowski LT, O'Connor RJ. Cigarette filter ventilation is a defective design because of misleading taste, bigger puffs, and blocked vents. Tob Control 2002;11 Suppl 1:I40-50.
49. Ho MK, Tyndale RF. Overview of the pharmacogenomics of cigarette smoking. Pharmacogenomics J 2007;7:81-98.
50. Johnstone E, Benowitz N, Cargill A, et al. Determinants of the rate of nicotine metabolism and effects on smoking behavior. Clin Pharmacol Ther 2006;80:319-30.
51. Pianezza ML, Sellers EM, Tyndale RF. Nicotine metabolism defect reduces smoking. Nature 1998;393:750.
52. Malaiyandi V, Sellers EM, Tyndale RF. Implications of CYP2A6 genetic variation for smoking behaviors and nicotine dependence. Clin Pharmacol Ther 2005;77:145-58.
53. O'Brien CP. Drug addiction and drug abuse. In: Brunton LL, Lazo JS, Parker KL, editors. Goodman and Gilman's the pharmacological basis of therapeutics. 11th ed New York: McGraw-Hill; 2006, p. 607-28.
54. Guindon GE, Boisclair D. Past, current and future trends in tobacco use. Washington (DC): TheWorld Bank; 2003.Available from: http://repositories. cdlib.org/cgi/viewcontent.cgi?article=1118&context=tc.
55. Shafey O, American Cancer Society. The tobacco atlas [1 atlas (128 p):]. Atlanta, GA: American Cancer Society; 2009.
56. Hatsukami DK, Parascandola M. Tobacco harm reduction. In: Boyle P, Gray N, Henningfield J, Seffrin J, ZatonskiW, editors. Tobacco, science, policy, and public health. New York: Oxford University Press, In press.
57. Kotlyar M, Mendoza-Baumgart MI, Li ZZ, et al. Nicotine pharmacokinetics and subjective effects of three potential reduced exposure products, moist snuff and nicotine lozenge. Tob Control 2007;16:138-42.
58. Griffiths RR, Bigelow GE, Ator NA. Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend 2003;70:S41-54.
59. Schoedel KA, Sellers EM. Assessing abuse liability during drug development: changing standards and expectations. Clin Pharmacol Ther 2008;83:622-6.
60. Stolerman IP, Jarvis MJ. The scientific case that nicotine is addictive. Psychopharmacology (Berl) 1995;117:2-10; discussion 4-20.
61. Henningfield JE, London ED, Pogun S. Handbook of experimental pharmacology 192. Nicotine psychopharmacology. Preface. Handb Exp Pharmacol 2009:v-viii.
62. Arfken CL, Cicero TJ. Postmarketing surveillance for drug abuse. Drug Alcohol Depend 2003;70:S97-105.
63. Brady KT, Lydiard RB, Brady JV. Assessing abuse liability in clinical trials. Drug Alcohol Depend 2003;70:S87-95.
64. Mansbach RS, Feltner DE, Gold LH, Schnoll SH. Incorporating the assessment of abuse liability into the drug discovery and development process. Drug Alcohol Depend 2003;70:S73-85.
65. McColl SL, Sellers EM. Research design strategies to evaluate the impact of formulations on abuse liability. Drug Alcohol Depend 2006;83 Suppl 1:S52-62.
66. Mansbach RS, Moore RA, Jr. Formulation considerations for the development of medications with abuse potential. Drug Alcohol Depend 2006;83 Suppl 1:S15-22.
67. Hatsukami DK, Hanson K, Briggs A, et al. Clinical trials methods for evaluation of potential reduced exposure products. Cancer Epidemiol Biomarkers Prev 2009;18:3143-95.
68. Hatsukami DK, Giovino GA, Eissenberg T, Clark PI, Lawrence D, Leischow S. Methods to assess potential reduced exposure products. Nicotine Tob Res 2005;7:827-44.
69. Comer SD, Ashworth JB, Foltin RW, Johanson CE, Zacny JP,Walsh SL. The role of human drug self-administration procedures in the development of medications. Drug Alcohol Depend 2008;96:1-15.
70. Haney M, Spealman R. Controversies in translational research: drug self-administration. Psychopharmacology (Berl) 2008;199:403-19.
71. Haney M. Self-administration of cocaine, cannabis and heroin in the human laboratory: benefits and pitfalls. Addict Biol 2009;14:9-21.
72. Schuster CR, Johanson CE. Relationship between the discriminative stimulus properties and subjective effects of drugs. Psychopharmacol Ser 1988;4:161-75.
73. Perkins KA. Discriminative stimulus effects of nicotine in humans. Handb Exp Pharmacol 2009:369-400.
74. Bickel WK, Bigelow GE, Preston KL, Liebson IA. Opioid drug discrimination in humans: stability, specificity and relation to self-reported drug effect. J Pharmacol Exp Ther 1989;251:1053-63.
75. Perkins KA, Sanders M, D'Amico D, Wilson A. Nicotine discrimination and self-administration in humans as a function of smoking status. Psychopharmacology (Berl) 1997;131:361-70.
76. Perkins KA, Fonte C, Sanders M, Meeker J, Wilson A. Threshold doses for nicotine discrimination in smokers and non-smokers. Psychopharmacology (Berl) 2001;155:163-70.
77. Perkins KA, Fonte C, Meeker J, WhiteW,Wilson A. The discriminative stimulus and reinforcing effects of nicotine in humans following nicotine pretreatment. Behav Pharmacol 2001;12:35-44.
78. Perkins KA, Fonte C, Sanders M, White W, Wilson A. Effects of training dose and two- versus three-choice testing procedure on nicotine discrimination responding in humans. Psychopharmacology (Berl) 1999;145:418-25.
79. Perkins KA, Epstein LH, Grobe JE, Fonte C. Tobacco abstinence, smoking cues, and the reinforcing value of smoking. Pharmacol Biochem Behav 1994;47:107-12.
80. Perkins KA, Sanders M, Fonte C, et al. Effects of central and peripheral nicotinic blockade on human nicotine discrimination. Psychopharmacology (Berl) 1999;142:158-64.
81. Rosecrans JA, Villanueva HF. Discriminative stimulus properties of nicotine: mechanisms of transduction. NIDA Res Monogr 1991: 101-16.
82. Rose JE. Multiple brain pathways and receptors underlying tobacco addiction. Biochem Pharmacol 2007;74:1263-70.
83. Rose JE, Sampson A, Levin ED, Henningfield JE. Mecamylamine increases nicotine preference and attenuates nicotine discrimination. Pharmacol Biochem Behav 1989;32:933-8.
84. Henningfield JE, Miyasato K, Jasinski DR. Abuse liability and pharmacodynamic characteristics of intravenous and inhaled nicotine. J Pharmacol Exp Ther 1985;234:1-12.
85. Houtsmuller EJ, Henningfield JE, Stitzer ML. Subjective effects of the nicotine lozenge: assessment of abuse liability. Psychopharmacology (Berl) 2003;167:20-7.
86. McColl SL, Burstein AH, Reeves KR, Billing CB, Jr., Stolar M, Sellers EM. Human abuse liability of the smoking cessation drug varenicline in smokers and nonsmokers. Clin Pharmacol Ther 2008;83:607-14.
87. Hughes JR. Should criteria for drug dependence differ across drugs? Addiction 2006;101 Suppl 1:134-41.
88. de Wit H, Griffiths RR. Testing the abuse liability of anxiolytic and hypnotic drugs in humans. Drug Alcohol Depend 1991;28:83-111.
89. Griffiths RR, Weerts EM. Benzodiazepine self-administration in humans and laboratory animals-implications for problems of long-term use and abuse. Psychopharmacology (Berl) 1997;134:1-37.
90. Gray JN, Breland AB, Weaver M, Eissenberg T. Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology. Nicotine Tob Res 2008;10:1441-8.
91. Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction 2007;102:324-34.
92. Carter LP, Griffiths RR, Suess PE, Casada JH, Wallace CL, Roache JD. Relative abuse liability of indiplon and triazolam in humans: a comparison of psychomotor, subjective, and cognitive effects. J Pharmacol Exp Ther 2007;322:749-59.
93. Hughes JR. Dependence potential and abuse liability of nicotine replacement therapies. Biomed Pharmacother 1989;43:11-7.
94. Breland AB, Evans SE, Buchhalter AR, Eissenberg T. Acute effects of Advance: a potential reduced exposure product for smokers. Tob Control 2002;11:376-8.
95. Blank MD, Sams C, Weaver MF, Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine Tob Res 2008;10:417-21.
96. Hatsukami DK, Fletcher L, Morgan S, Keenan R, Amble P. The effects of varying cigarette deprivation duration on cognitive and performance tasks. J Subst Abuse 1989;1:407-16.
97. Butschky MF, Bailey D, Henningfield JE, Pickworth WB. Smoking without nicotine delivery decreases withdrawal in 12-hour abstinent smokers. Pharmacol Biochem Behav 1995;50:91-6.
98. Sokolowska M, Setnik B, Jones J, Johnson F, Romach M, Sellers E. Validation of assessments for abuse liability trials. Presented at the College on Problems of Drug Dependence 70th Annual Meeting (Abstract); 2008.
99. West R, Hajek P, Foulds J, Nilsson F, May S, Meadows A. A comparison of the abuse liability and dependence potential of nicotine patch, gum, spray and inhaler. Psychopharmacology (Berl) 2000;149:198-202.
100. Westman EC, Behm FM, Rose JE. Dissociating the nicotine and airway sensory effects of smoking. Pharmacol Biochem Behav 1996;53:309-15.
101. Rose JE. Nicotine and nonnicotine factors in cigarette addiction. Psychopharmacology (Berl) 2006;184:274-85.
102. Rose JE, Zinser MC, Tashkin DP, Newcomb R, Ertle A. Subjective response to cigarette smoking following airway anesthetization. Addict Behav 1984;9:211-5.
103. Rose JE, Behm FM, Westman EC, Bates JE. Mecamylamine acutely increases human intravenous nicotine self-administration. Pharmacol Biochem Behav 2003;76:307-13.
104. Rose JE, Westman EC, Behm FM, Johnson MP, Goldberg JS. Blockade of smoking satisfaction using the peripheral nicotinic antagonist trimethaphan. Pharmacol Biochem Behav 1999;62:165-72.
105. Hughes JR, Higgins ST, Hatsukami D. Effects of abstinence from tobacco: a critical review. In: Kozlowski LT, Annis H, Cappell HD, et al., editors. Research advances in alcohol and drug problems. New York: Plenum Press; 1990, p. 317-98.
106. Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res 2007;9:315-27.
107. Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry 1986;43:289-94.
108. Gross J, Stitzer ML. Nicotine replacement: ten-week effects on tobacco withdrawal symptoms. Psychopharmacology (Berl) 1989;98:334-41.
109. Hughes JR, Hatsukami DK. Errors in using tobacco withdrawal scale. Tob Control 1998;7:92-3.
110. Ward MM, Swan GE, Jack LM. Self-reported abstinence effects in the first month after smoking cessation. Addict Behav 2001;26:311-27.
111. Hughes JR, Higgins ST, Bickel WK. Nicotine withdrawal versus other drug withdrawal syndromes: similarities and dissimilarities. Addiction 1994;89:1461-70.
112. Shiffman SM, Jarvik ME. Smoking withdrawal symptoms in two weeks of abstinence. Psychopharmacology (Berl) 1976;50:35-9.
113. Heatherton TF, Koslowski LT, Frecker RC, Fagerström K-O. The Fagerström Test for nicotine dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict 1991;86:1119-27.
114. Buchhalter AR, Schrinel L, Eissenberg T.Withdrawal-suppressing effects of a novel smoking system: comparison with ownbrand, notownbrand, and de-nicotinized cigarettes. Nicotine Tob Res 2001;3:111-8.
115. Breland AB, Acosta MC, Eissenberg T. Tobacco specific nitrosamines and potential reduced exposure products for smokers: a preliminary evaluation of Advance. Tob Control 2003;12:317-21.
116. Breland AB, Buchhalter AR, Evans SE, Eissenberg T. Evaluating acute effects of potential reduced-exposure products for smokers: clinical laboratory methodology. Nicotine Tob Res 2002;4 Suppl 2:S131-40.
117. Buchhalter AR, Acosta MC, Evans SE, Breland AB, Eissenberg T. Tobacco abstinence symptom suppression: the role played by the smoking-related stimuli that are delivered by denicotinized cigarettes. Addiction 2005;100:550-9.
118. Tiffany ST, Drobes DJ. The development and initial validation of a questionnaire on smoking urges. Br J Addict 1991;86:1467-76.
119. Sayette MA, Shiffman S, Tiffany ST, Niaura RS, Martin CS, Shadel WG. The measurement of drug craving. Addiction 2000;95 Suppl 2:S189-210.
120. O'Brien CP. Anticraving medications for relapse prevention: a possible new class of psychoactive medications. Am J Psychiatry 2005;162: 1423-31.
121. Killen JD, Fortmann SP. Craving is associated with smoking relapse: findings from three prospective studies. Exp Clin Psychopharmacol 1997;5:137-42.
122. Shiffman S, West R, Gilbert D, SRNT Work Group on the Assessment of Craving andWithdrawal in Clinical Trials. Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials. Nicotine Tob Res 2004;6:599-614.
123. DiFranza JR, Wellman RJ. A sensitization-homeostasis model of nicotine craving, withdrawal, and tolerance: integrating the clinical and basic science literature. Nicotine Tob Res 2005;7:9-26.
124. Ferguson SG, Shiffman S. The relevance and treatment of cue-induced cravings in tobacco dependence. J Subst Abuse Treat 2009;36:235-43.
125. Shiffman S, Shadel WG, Niaura R, et al. Efficacy of acute administration of nicotine gum in relief of cue-provoked cigarette craving. Psychopharmacology (Berl) 2003;166:343-50.
126. Heishman SJ, Singleton EG, Pickworth WB. Reliability and validity of a short form of the Tobacco Craving Questionnaire. Nicotine Tob Res 2008;10:643-51.
127. Henningfield JE, Goldberg SR. Nicotine as a reinforcer in humansubjects and laboratory animals. Pharmacol Biochem Behav 1983;19:989-92.
128. Harvey DM, Yasar S, Heishman SJ, Panlilio LV, Henningfield JE, Goldberg SR. Nicotine serves as an effective reinforcer of intravenous drug-taking behavior in human cigarette smokers. Psychopharmacology (Berl) 2004;175:134-42.
129. Sofuoglu M, Yoo S, Hill KP, Mooney M. Self-administration of intravenous nicotine in male and female cigarette smokers. Neuropsychopharmacology 2008;33:715-20.
130. Henningfield JE, Miyasato K, Jasinski DR. Cigarette smokers self-administer intravenous nicotine. Pharmacol Biochem Behav 1983;19:887-90.
131. Griffiths RR, Henningfield JE, Bigelow GE. Human cigarette smoking: manipulation of number of puffs per bout, interbout interval and nicotine dose. J Pharmacol Exp Ther 1982;220:256-65.
132. Dallery J, Houtsmuller EJ, Pickworth WB, Stitzer ML. Effects of cigarette nicotine content and smoking pace on subsequent craving and smoking. Psychopharmacology (Berl) 2003;165:172-80.
133. Kassel JD, Greenstein JE, Evatt DP, et al. Smoking topography in response to denicotinized and high-yield nicotine cigarettes in adolescent smokers. J Adolesc Health 2007;40:54-60.
134. Strasser AA, Lerman C, Sanborn PM, Pickworth WB, Feldman EA. New lower nicotine cigarettes can produce compensatory smoking and increased carbon monoxide exposure. Drug Alcohol Depend 2007;86:294-300.
135. Mendes P, Kapur S, Wang J, Feng S, Roethig H. A randomized, controlled exposure study in adult smokers of full flavor Marlboro cigarettes switching to Marlboro Lights or Marlboro Ultra Lights cigarettes. Regul Toxicol Pharmacol 2008;51:295-305.
136. Breland AB, Kleykamp BA, Eissenberg T. Clinical laboratory evaluation of potential reduced exposure products for smokers. Nicotine Tob Res 2006;8:727-38.
137. Stafford D, LeSage MG, Glowa JR. Progressive-ratio schedules of drug delivery in the analysis of drug self-administration: a review. Psychopharmacology (Berl) 1998;139:169-84.
138. Stoops WW. Reinforcing effects of stimulants in humans: sensitivity of progressive-ratio schedules. Exp Clin Psychopharmacol 2008;16:503-12.
139. DeGrandpre RJ, Bickel WK, Higgins ST, Hughes JR. A behavioral economic analysis of concurrently available money and cigarettes. J Exp Anal Behav 1994;61:191-201.
140. Madden GJ, Bickel WK, Jacobs EA. Three predictions of the economic concept of unit price in a choice context. J Exp Anal Behav 2000;73:45-64.
141. Bickel WK, Marsch LA, Carroll ME. Deconstructing relative reinforcing efficacy and situating the measures of pharmacological reinforcement with behavioral economics: a theoretical proposal. Psychopharmacology (Berl) 2000;153:44-56.
142. Hursh SR, Winger G. Normalized demand for drugs and other reinforcers. J Exp Anal Behav 1995;64:373-84.
143. Jacobs EA, Bickel WK. Modeling drug consumption in the clinic using simulation procedures: demand for heroin and cigarettes in opioiddependent outpatients. Exp Clin Psychopharmacol 1999;7:412-26.
144. MacKillop J, Murphy JG, Ray LA, et al. Further validation of a cigarette purchase task for assessing the relative reinforcing efficacy of nicotine in college smokers. Exp Clin Psychopharmacol 2008;16:57-65.
145. Murphy JG, MacKillop J. Relative reinforcing efficacy of alcohol among college student drinkers. Exp Clin Psychopharmacol 2006;14: 219-27.
146. Mackillop J, Murphy JG, Tidey JW, Kahler CW, Ray LA, Bickel WK. Latent structure of facets of alcohol reinforcement from a behavioral economic demand curve. Psychopharmacology (Berl) 2009;203:33-40.
147. MacKillop J, Murphy JG. A behavioral economic measure of demand for alcohol predicts brief intervention outcomes. Drug Alcohol Depend 2007;89:227-33.
148. Johnson MW, Bickel WK, Kirshenbaum AP. Substitutes for tobacco smoking: a behavioral economic analysis of nicotine gum, denicotinized cigarettes, and nicotine-containing cigarettes. Drug Alcohol Depend 2004;74:253-64.
149. Johnson MW, Bickel WK. The behavioral economics of cigarette smoking: the concurrent presence of a substitute and an independent reinforcer. Behav Pharmacol 2003;14:137-44.
150. Mendoza-Baumgart MI, Tulunay OE, Hecht SS, et al. Pilot study on lower nitrosamine smokeless tobacco products compared with medicinal nicotine. Nicotine Tob Res 2007;9:1309-23.
151. Fagerstrom KO, Hughes JR, Callas PW. Long-term effects of the Eclipse cigarette substitute and the nicotine inhaler in smokers not interested in quitting. Nicotine Tob Res 2002;4 Suppl 2:S141-5.
152. Griffiths RR, Rush CR, Puhala K. Validation of the multiple-choice procedure for investigating drug reinforcement in humans. Exp Clin Psychopharmacol 1996;4:97-106.
153. Griffiths RR, Troisi JR, Silverman K, Mumford GK. Multiple-choice procedure: an efficient approach for investigating drug reinforcement in humans. Behav Pharmacol 1993;4:3-13.
154. Jones HE, Garrett BE, Griffiths RR. Subjective and physiological effects of intravenous nicotine and cocaine in cigarette smoking cocaine abusers. J Pharmacol Exp Ther 1999;288:188-97.
155. Sobel BF, Sigmon SC, Griffiths RR. Transdermal nicotine maintenance attenuates the subjective and reinforcing effects of intravenous nicotine, but not cocaine or caffeine, in cigarette-smoking stimulant abusers. Neuropsychopharmacology 2004;29:991-1003.
156. Schuh LM, Schuster CR, Hopper JA, Mendel CM. Abuse liability assessment of sibutramine, a novel weight control agent. Psychopharmacology (Berl) 2000;147:339-46.
157. Bickel WK, DeGrandpre RJ, Higgins ST. The behavioral economics of concurrent drug reinforcers: a review and reanalysis of drug self-administration research. Psychopharmacology (Berl) 1995;118:250-9.
158. Pickworth WB, Herning RI, Henningfield JE. Electroencephalographic effects of nicotine chewing gum in humans. Pharmacol Biochem Behav 1986;25:879-82.
159. Pickworth WB, Fant RV, Butschky MF, Henningfield JE. Effects of transdermal nicotine delivery on measures of acute nicotine withdrawal. J Pharmacol Exp Ther 1996;279:450-6.
160. Pickworth WB, O'Hare ED, Fant RV, Moolchan ET. EEG effects of conventional and denicotinized cigarettes in a spaced smoking paradigm. Brain Cogn 2003;53:75-81.
161. Pickworth WB, Herning RI, Henningfield JE. Spontaneous EEG changes during tobacco abstinence and nicotine substitution in human volunteers. J Pharmacol Exp Ther 1989;251:976-82.
162. Herning RI, Jones RT, Bachman J. EEG changes during tobacco withdrawal. Psychophysiology 1983;20:507-12.
163. Pickworth WB, Herning RI, Henningfield JE. Mecamylamine reduces some EEG effects of nicotine chewing gum in humans. Pharmacol Biochem Behav 1988;30:149-53.
164. Azizian A, Monterosso J, O'Neill J, London ED. Magnetic resonance imaging studies of cigarette smoking. Handb Exp Pharmacol 2009: 113-43.
165. Sharma A, Brody AL. In vivo brain imaging of human exposure to nicotine and tobacco. Handb Exp Pharmacol 2009:145-71.
166. 18F]fluoro-A-85380, a high-affinity ligand for α4β2* nicotinic acetylcholine receptors. Synapse 2005;55:89-97.
167. Cordero-Erausquin M, Marubio LM, Klink R, Changeux JP. Nicotinic receptor function: new perspectives from knockout mice. Trends Pharmacol Sci 2000;21:211-7.
168. Brody AL, Mandelkern MA, London ED, et al. Cigarette smoking saturates brain α4β2 nicotinic acetylcholine receptors. Arch Gen Psychiatry 2006;63:907-15.
169. Brody AL, Mandelkern MA, Olmstead RE, et al. Ventral striatal dopamine release in response to smoking a regular vs a denicotinized cigarette. Neuropsychopharmacology 2009;34:282-9.
170. Brody AL, Mandelkern MA, Olmstead RE, et al. Gene variants of brain dopamine pathways and smoking-induced dopamine release in the ventral caudate/nucleus accumbens. Arch Gen Psychiatry 2006;63:808-16.
171. Moolchan ET, Robinson ML, Ernst M, et al. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction. Pediatrics 2005;115:e407-14.
172. Gonzales D, Rennard SI, Nides M, et al. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006;296:47-55.
173. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an á4â2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA 2006;296:56-63.
174. Bigelow GE, Griffiths RR, Liebson I, Kaliszak JE. Double-blind evaluation of reinforcing and anorectic actions of weight control medications. Interaction of pharmacological and behavioral treatments. Arch Gen Psychiatry 1980;37:1118-23.
175. Tonstad S, Tonnesen P, Hajek P, et al. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA 2006;296:64-71.
176. Dasgupta N, Schnoll SH. Signal detection in post-marketing surveillance for controlled substances. Drug Alcohol Depend 2009, Epub ahead of print.
177. Cone EJ. Ephemeral profiles of prescription drug and formulation tampering: evolving pseudoscience on the Internet. Drug Alcohol Depend 2006;83 Suppl 1:S31-9.
178. O'Connor RJ, Cummings KM, Rees VW, et al. Surveillance methods for identifying, characterizing, and monitoring tobacco products: potential reduced exposure products as an example. Cancer Epidemiol Biomarkers Prev 2009;18:3334-48.
179. Woolf A, Burkhart K, Caraccio T, Litovitz T. Self-poisoning among adults using multiple transdermal nicotine patches. J Toxicol Clin Toxicol 1996;34:691-8.
180. World Health Organization. WHO Expert Committee on Drug Dependence, thirty-third report, technical report series, no. 915. Geneva, Switzerland: World Health Organization; 2003.
181. Le Foll B, Goldberg SR. Nicotine as a typical drug of abuse in experimental animals and humans. Psychopharmacology (Berl) 2006;184: 367-81.
182. Perkins KA. Individual variability in responses to nicotine. Behav Genet 1995;25:119-32.
183. Perkins KA, D'Amico D, Sanders M, Grobe JE, Wilson A, Stiller RL. Influence of training dose on nicotine discrimination in humans. Psychopharmacology (Berl) 1996;126:132-9.
184. Kleykamp BA, Jennings JM, Sams C, Weaver MF, Eissenberg T. The influence
185. Leventhal AM,Waters AJ, Boyd S, Moolchan ET, Lerman C, Pickworth WB. Gender differences in acute tobacco withdrawal: effects on subjective, cognitive, and physiological measures. Exp Clin Psychopharmacol 2007;15:21-36.
186. McClernon FJ, Kollins SH. ADHD and smoking: from genes to brain to behavior. Ann N Y Acad Sci 2008;1141:131-47.
187. Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness. JAMA 2000;284:2606-10.
188. John U, Meyer C, Rumpf HJ, Hapke U. Smoking, nicotine dependence and psychiatric comorbidity-a population-based study including smoking cessation after three years. Drug Alcohol Depend 2004;76:287-95.
189. Newcomer JW. Medical risk in patients with bipolar disorder and schizophrenia. J Clin Psychiatry 2006;67:e16.
190. Strasser AA, Kaufmann V, Jepson C, et al. Effects of different nicotine replacement therapies on postcessation psychological responses. Addict Behav 2005;30:9-17.
191. Evans SM, Cone EJ, Henningfield JE. Arterial and venous cocaine plasma concentrations in humans: relationship to route of administration, cardiovascular effects and subjective effects. J Pharmacol Exp Ther 1996;279:1345-56.
192. Sellers EM, Schuller R, Romach MK, Horbay GL. Relative abuse potential of opioid formulations in Canada: a structured field study. J Opioid Manag 2006;2:219-27.
193. Rees VW, Kreslake JM, O'connor RJ, et al. Assessing consumer responses to PREPs: a review of tobacco industry. Cancer Epidemiol Biomarkers Prev 2009;18:3224-38.