Medication screening for smoking cessation: A proposal for new methodologies
Abstract
Rationale The purpose of medication screening studies is to quickly and cheaply evaluate the clinical potential of medications, so that promising drugs proceed to large-scale clinical trials and unpromising drugs do not. Screening procedures for smoking cessation medications either are not sufficiently practical or lack clinical validity. Clinical trials have clinical validity but are often impractical as initial tests of efficacy (i.e., screening) or suffer from limited statistical power. The alternative approach of short-term, laboratory-based studies of purported mechanisms of efficacy may overcome some of the practical problems of clinical trials but appear to have limited clinical validity.Objectives This commentary identifies some of the limitations of current short-term screening procedures and provides suggestions for improving such studies.Results Short-term screening studies typically use smokers unmotivated to abstain (i.e., nontreatment seekers) as participants and examine brief medication effects on clinical markers or potential mechanisms of action, including relief of withdrawal and craving during enforced abstinence or on reduction in the reinforcing effects of smoked tobacco. The limitation of these approaches is shown by their insensitivity to effects of nicotine replacement and bupropion, which are effective in clinical trials for smoking cessation.Conclusions The clinical validity of short-term screening studies may improve if these studies simulate some clinical trial procedures within practical limitations. Thus, they should recruit smokers motivated to abstain, emphasize smoking abstinence as a primary index of medication response, examine effects over sufficiently long time periods to encompass the drug's mechanism of action, and assess responses in the natural environment. Whether these changes improve the sensitivity of screening studies is testable. Other research aimed specifically at identifying the mechanisms of therapeutic action of a medication may also profit from using this approach of simulating a short-term clinical trial.
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The within-subject crossover design and enrollment of treatment-seeking smokers provides a more sensitive test of medication effects.
“The within-subject cross-over design and enrollment of treatment-seeking smokers provides a more sensitive test of medication effects (19).”
From Varenicline improves mood and cognition during smoking abstinence (2009) · cites this paper as [19]
Cites
Nicotine replacement therapy for smoking cessation
Stead, L. F., Perera, R., Bullen, C., Mant, D., Hartmann‐Boyce, J., Cahill, K., & Lancaster, T. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000146.pub4 · Cited by 2,514 · see citing works
Meta‐analysis of cue‐reactivity in addiction research
Carter, B. L., & Tiffany, S. T. (1999) · Addiction · doi:10.1046/j.1360-0443.1999.9433273.x · Cited by 1,638 · cited 2× · see citing works
“Typically, these “cue reactivity” studies show increases in physiological responses, including heart rate, and in self-reported urge in response to smoking- related stimuli (Carter and Tiffany 1999).”
BackgroundAntidepressants for smoking cessation
Howes, S., Hartmann-Boyce, J., Livingstone-Banks, J., Hong, B., & Lindson, N. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000031.pub5 · Cited by 1,352 · see citing works
A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation
Hurt, R. D., Sachs, D. P. L., Glover, E. D., Offord, K. P., Johnston, J. A., Dale, L. C., Khayrallah, M. A., Schroeder, D. R., Glover, P. N., Sullivan, C. R., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199710233371703 · Cited by 1,253 · see citing works
Nicotine replacement therapy for smoking cessation
Silagy, C., Lancaster, T., Stead, L., Mant, D., & Fowler, G. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000146.pub2 · Cited by 972 · see citing works
Capturing momentary, self-report data: A proposal for reporting guidelines
Stone, A. A., & Shiffman, S. (2002) · Annals of Behavioral Medicine · doi:10.1207/s15324796abm2403_09 · Cited by 807 · see citing works
Applying extinction research and theory to cue‐exposure addiction treatments
Conklin, C. A., & Tiffany, S. T. (2002) · Addiction · doi:10.1046/j.1360-0443.2002.00014.x · Cited by 702 · see citing works
Antidepressants for smoking cessation
Hughes, J., Stead, L., & Lancaster, T. (2003) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000031 · Cited by 683 · see citing works
Cue dependency of nicotine self-administration and smoking
Caggiula, A. R., Donny, E. C., White, A. R., Chaudhri, N., Booth, S., Gharib, M. A., Hoffman, A., Perkins, K. A., & Sved, A. F. (2001) · Pharmacology Biochemistry and Behavior · doi:10.1016/s0091-3057(01)00676-1 · Cited by 425 · see citing works
Self-citationCraving is associated with smoking relapse: Findings from three prospective studies.
Killen, J. D., & Fortmann, S. P. (1997) · Experimental and Clinical Psychopharmacology · doi:10.1037//1064-1297.5.2.137 · Cited by 413 · see citing works
A Range of Research-Based Pharmacotherapies for Addiction
O’Brien, C. P. (1997) · Science · doi:10.1126/science.278.5335.66 · Cited by 385 · see citing works
Craving is associated with smoking relapse: Findings from three prospective studies.
Killen, J. D., & Fortmann, S. P. (1997) · Experimental and Clinical Psychopharmacology · doi:10.1037/1064-1297.5.2.137 · Cited by 342 · see citing works
Transdermal Nicotine for Smoking Cessation
Christen, A. G. (1991) · JAMA · doi:10.1001/jama.1991.03470220049025 · Cited by 318 · see citing works
Effect of nicotine on the tobacco withdrawal syndrome
Hughes, J. R., Hatsukami, D. K., Pickens, R. W., Krahn, D. D., Malin, S., & Luknic, A. (1984) · Psychopharmacology · doi:10.1007/bf00427428 · Cited by 286 · see citing works
Predicting relapse back to smoking: Contrasting affective and physical models of dependence.
Kenford, S. L., Smith, S. S., Wetter, D. W., Jorenby, D. E., Fiore, M. C., & Baker, T. B. (2002) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.70.1.216 · Cited by 279 · see citing works
The effect of bupropion on nicotine craving and withdrawal
Shiffman, S. S., Johnston, J. A., Khayrallah, M. A., Elash, C. A., Gwaltney, C. J., Paty, J. A., Gnys, M., Evoniuk, G. E., & DeVeaugh-Geiss, J. (2000) · Psychopharmacology · doi:10.1007/s002130050022 · Cited by 260 · see citing works
How effective is nicotine replacement therapy in helping people to stop smoking?
Tang, J.-L., Law, M. G., & Wald, N. (1994) · BMJ · doi:10.1136/bmj.308.6920.21 · Cited by 223 · see citing works
Regional, disease specific patterns of smoking-attributable mortality in 2000
Ezzati, M., & López, A. D. (2004) · Tobacco Control · doi:10.1136/tc.2003.005215 · Cited by 209 · see citing works
Cue-Provoked Craving and Nicotine Replacement Therapy in Smoking Cessation.
Waters, A. J., Shiffman, S. S., Sayette, M. A., Paty, J. A., Gwaltney, C. J., & Balabanis, M. H. (2004) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.72.6.1136 · Cited by 201 · see citing works
Tiffany, S. T., Cox, L. S., & Elash, C. A. (2000) · Journal of Consulting and Clinical Psychology · doi:10.1037//0022-006x.68.2.233 · Cited by 196 · see citing works
Responses to smoking-related stimuli and early relapse to smoking
NIAURA, R. S., Abrams, D. B., Demuth, B., Pinto, R. P., & Monti, P. M. (1989) · Addictive Behaviors · doi:10.1016/0306-4603(89)90029-4 · Cited by 176 · see citing works
Antidepressants for smoking cessation
Hughes, J., Stead, L., & Lancaster, T. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000031.pub2 · Cited by 172 · see citing works
Johnson, M. W., Bickel, W. K., & Kirshenbaum, A. P. (2004) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2003.12.012 · Cited by 154 · see citing works
Tiffany, S. T., Cox, L. S., & Elash, C. A. (2000) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.68.2.233 · Cited by 141 · see citing works
The increasing recalcitrance of smokers in clinical trials
Irvin, T. H. B. J. E. (2000) · Nicotine & Tobacco Research · doi:10.1080/14622200050011330 · Cited by 129 · see citing works
Assessing ‘stage of change’ in current and former smokers
Etter, J., & Sutton, S. R. (2002) · Addiction · doi:10.1046/j.1360-0443.2002.00198.x · Cited by 125 · see citing works
West, R., & Shiffman, S. (2001) · Psychopharmacology · doi:10.1007/s002130100712 · Cited by 115 · see citing works
Acute doses of d-amphetamine and bupropion increase cigarette smoking
Cousins, M. S., Stamat, H. M., & de Wit, H. (2001) · Psychopharmacology · doi:10.1007/s002130100802 · Cited by 111 · see citing works
Suppression of nicotine intake during ad libitum cigarette smoking by high-dose transdermal nicotine
Benowitz, N. L., Zevin, S., & Jacob, P. (1998) · The Journal of Pharmacology and Experimental Therapeutics · doi:10.1016/s0022-3565(24)37887-5 · Cited by 108 · see citing works
Etter, J., Laszlo, E., Zellweger, J.-P., Perrot, C., & Perneger, T. (2002) · Journal of Clinical Psychopharmacology · doi:10.1097/00004714-200210000-00008 · Cited by 103 · see citing works
Transdermal Nicotine for Smoking Cessation.
Hughes, J. R., & Glaser, M. (1993) · Cited by 102 · see citing works
Christen, A. G., Beiswanger, B. B., MAU, M. S., Walker, C. H., Hatsukami, D. K., ALLEN, S. S., Huber, M., Jensen, J., Rennard, S. I., Daughton, D. M., et al. (1991) · JAMA · doi:10.1001/jama.266.22.3133 · Cited by 87 · see citing works
Investigating the actions of bupropion on dependence-related effects of nicotine in rats
Shoaib, M. C., Sidhpura, N., & Shafait, S. (2003) · Psychopharmacology · doi:10.1007/s00213-002-1277-x · Cited by 84 · see citing works
LeSage, M. G., Keyler, D. E., Collins, G., & Pentel, P. R. (2003) · Psychopharmacology · doi:10.1007/s00213-003-1539-2 · Cited by 82 · see citing works
Harm Reduction Approaches to Reducing Tobacco-Related Mortality
Hatsukami, D. K., Henningfield, J. E., & Kotlyar, M. (2004) · Annual Review of Public Health · doi:10.1146/annurev.publhealth.25.102802.124406 · Cited by 82 · see citing works
Gilbert, D. G., Crauthers, D. M., Mooney, D. K., McClernon, F. J., & Jensen, R. A. (1999) · Experimental and Clinical Psychopharmacology · doi:10.1037//1064-1297.7.2.174 · Cited by 81 · see citing works
Smokers deprived of cigarettes for 72 h: effect of nicotine patches on craving and withdrawal
Teneggi, V., Tiffany, S. T., Squassante, L., Milleri, S., Ziviani, L., & Bye, A. (2002) · Psychopharmacology · doi:10.1007/s00213-002-1176-1 · Cited by 81 · see citing works
CONTINGENT PAYMENT PROCEDURES FOR SMOKING REDUCTION AND CESSATION
Stitzer, M. L., Rand, C. S., Bigelow, G. E., & Mead, A. M. (1986) · Journal of Applied Behavior Analysis · doi:10.1901/jaba.1986.19-197 · Cited by 80 · see citing works
Self-citationExperimental model of smoking re-exposure: effects on relapse
Chornock, W. M., Stitzer, M. L., Gross, J., & Leischow, S. J. (1992) · Psychopharmacology · doi:10.1007/bf02247427 · Cited by 77 · see citing works
Self-citationEffect of Bupropion on Depression Symptoms in a Smoking Cessation Clinical Trial.
Lerman, C. E., NIAURA, R. S., Collins, B. N., Wileyto, E. P., Audrain-McGovern, J. E., Pinto, A. G., Hawk, L. W., & Epstein, L. H. (2004) · Psychology of Addictive Behaviors · doi:10.1037/0893-164x.18.4.362 · Cited by 77 · see citing works
Self-citationEffects of behavioral and pharmacological treatment on smokeless tobacco users.
Hatsukami, D. K., Jensen, J. A., ALLEN, S. S., Grillo, M., & Bliss, R. (1996) · Journal of Consulting and Clinical Psychology · doi:10.1037//0022-006x.64.1.153 · Cited by 75 · see citing works
Nicotine preference in smokers as a function of smoking abstinence
Perkins, K. A., Grobe, J. E., Weiss, D., Fonte, C. A., & Caggiula, A. R. (1996) · Pharmacology Biochemistry and Behavior · doi:10.1016/s0091-3057(96)00079-2 · Cited by 75 · see citing works
Self-citationTransdermal nicotine: reduction of smoking with minimal abuse liability
Pickworth, W. B., Bunker, E. B., & Henningfield, J. E. (1994) · Psychopharmacology · doi:10.1007/bf02244745 · Cited by 67 · see citing works
Symptoms of tobacco withdrawal from total cigarette cessation versus partial cigarette reduction
Hatsukami, D. K., Dahlgren, L., Zimmerman, R., & Hughes, J. (1988) · Psychopharmacology · doi:10.1007/bf00176853 · Cited by 64 · see citing works
Naltrexone reduces the relative reinforcing value of nicotine in a cigarette smoking choice paradigm
Rukstalis, M. R., Jepson, C., Strasser, A. A., Lynch, K. G., Perkins, K. A., Patterson, F., & Lerman, C. E. (2005) · Psychopharmacology · doi:10.1007/s00213-004-2136-8 · Cited by 62 · see citing works
Self-citationAn Experimental Examination of the Initial Weeks of Abstinence in Cigarette Smokers.
Alessi, S. M., Badger, G. J., & Higgins, S. T. (2004) · Experimental and Clinical Psychopharmacology · doi:10.1037/1064-1297.12.4.276 · Cited by 62 · see citing works
Gilbert, D. G., Crauthers, D. M., Mooney, D. K., et al. (1999) · Experimental and Clinical Psychopharmacology · doi:10.1037/1064-1297.7.2.174 · Cited by 62 · see citing works
Nicotine gum: dose-related effects on cigarette smoking and subjective ratings
Nemeth-Coslett, R., Henningfield, J. E., O'Keeffe, M. K., & Griffiths, R. R. (1987) · Psychopharmacology · doi:10.1007/bf00176472 · Cited by 58 · see citing works
Effects of behavioral and pharmacological treatment on smokeless tobacco users.
Hatsukami, D. K., Jensen, J. A., ALLEN, S. S., et al. (1996) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.64.1.153 · Cited by 58 · see citing works
To increase power in randomized clinical trials without increasing sample size.
Hc, K. (1991) · PubMed · Cited by 57 · see citing works
Perkins, K. A., Broge, M., Gerlach, D., SANDERS, M. H., Grobe, J. E., Cherry, C. R., & Wilson, A. S. (2002) · Health Psychology · doi:10.1037//0278-6133.21.4.332 · Cited by 51 · see citing works
Self-citationNon-Nicotine Pharmacotherapy for Smoking Cessation
Benowitz, N. L., & Peng, M. W. (2000) · CNS Drugs · doi:10.2165/00023210-200013040-00004 · Cited by 46 · see citing works
Effects of nicotine chewing gum on cigarette smoking and subjective and physiologic effects
Nemeth-Coslett, R., & Henningfield, J. E. (1986) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.1986.110 · Cited by 42 · see citing works
Cotinine: effects with and without nicotine
Hatsukami, D., Pentel, P. R., Jensen, J. A., Nelson, D. B., ALLEN, S. S., Goldman, A. I., & Raphael, D. E. (1998) · Psychopharmacology · doi:10.1007/s002130050495 · Cited by 38 · see citing works
(1998) · doi:10.1007/s002130050744 · Cited by 37 · see citing works
Martı́nez-Raga, J., Keaney, F., Sutherland, G., Gálvez, B. P., & Strang, J. (2003) · Addiction Biology · doi:10.1080/1355621031000069837 · Cited by 34 · see citing works
Effect of Cue Exposure, Urge to Smoke, and Nicotine Deprivation on Cognitive Performance in Smokers.
Havermans, R. C., Debaere, S., Smulders, F. T. Y., Wiers, R. W. H. J., & Jansen, A. T. M. (2003) · Psychology of Addictive Behaviors · doi:10.1037/0893-164x.17.4.336 · Cited by 33 · see citing works
Perkins, K. A., Broge, M., Gerlach, D., et al. (2002) · Health Psychology · doi:10.1037/0278-6133.21.4.332 · Cited by 33 · see citing works
Self-citationKroboth, P. D., Schmith, V. D., & Smith, R. B. (1991) · Clinical Pharmacokinetics · doi:10.2165/00003088-199120020-00001 · Cited by 30 · see citing works
Zernig, G., de Wit, H., Telser, S., et al. (2004) · Pharmacology · doi:10.1159/000075550 · Cited by 30 · see citing works
Rate of nicotine onset from nicotine replacement therapy and acute responses in smokers
Perkins, K. A., Lerman, C. E., Keenan, J., et al. (2004) · Nicotine & Tobacco Research · doi:10.1080/14622200410001696547 · Cited by 27 · see citing works
Self-citationSubjective effects of an initial dose of nicotine nasal spray predict treatment outcome
Rukstalis, M. R., Perkins, K. A., Audrain-McGovern, J. E., Lerman, C. E., Jepson, C., & Kaufmann, V. (2004) · Psychopharmacology · doi:10.1007/s00213-003-1659-8 · Cited by 15 · see citing works
Self-citationComparative Efficacy and Tolerability of Nicotine Replacement Therapies
Jorenby, D. E., Keehn, D. S., & Fiore, M. C. (1995) · CNS Drugs · doi:10.2165/00023210-199503030-00007 · Cited by 11 · see citing works
Development of Medications for Addictive Disorders
Vocci, F. J. (1996) · Handbook of experimental pharmacology · doi:10.1007/978-3-642-60963-3_13 · Cited by 2 · see citing works
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Stress decreases the ability to resist smoking and potentiates smoking intensity and reward
McKee, S. A., Sinha, R., Weinberger, A. H., Sofuoglu, M., Harrison, E. L., Lavery, M., & Wanzer, J. (2011) · Journal of Psychopharmacology · doi:10.1177/0269881110376694 · Cited by 276 · see citing works
Varenicline improves mood and cognition during smoking abstinence
Patterson, F., Jepson, C., Strasser, A. A., Loughead, J., Perkins, K. A., Gur, R. C., Frey, J. M., Siegel, S., & Lerman, C. (2009) · Biological Psychiatry · doi:10.1016/j.biopsych.2008.08.028 · Cited by 222 · see citing works
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McKee, S. A. (2009) · Addiction Biology · doi:10.1111/j.1369-1600.2008.00135.x · Cited by 93 · see citing works
Carpenter, M. J., Alberg, A. J., Gray, K. M., & Saladin, M. E. (2010) · Clinical Trials · doi:10.1177/1740774510361533 · Cited by 41 · see citing works
The effects of varenicline on stress-induced and cue-induced craving for cigarettes
Ray, L. A., Lunny, K., Bujarski, S., Moallem, N., Krull, J. L., & Miotto, K. (2013) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2012.12.015 · Cited by 27 · see citing works
Improving efficiency of initial tests for efficacy in smoking cessation drug discovery
Perkins, K. A. (2014) · Expert Opinion on Drug Discovery · doi:10.1517/17460441.2014.951632 · Cited by 11 · see citing works
Self-citation
- Authors
- Perkins, K. A., Stitzer, M., & Lerman, C.
- Affiliations
- University of Pittsburgh (US)
- Johns Hopkins University (US)
- Abramson Cancer Center (US)
- Corresponding author
- Perkins, Kenneth A.
- Venue
- Psychopharmacology
- Published
- 2005-09-15
- Volume
- 184
- Issue
- 3-4
- Pages
- 628-636
- ISSN
- 0033-3158 (ISSN-L)
- 1432-2072
- OpenAlex
- W2128149876
- Cited by
- 91
- References
- 64
- Citations by year
- 2023: 1 · 2022: 5 · 2021: 1 · 2020: 5 · 2019: 5 · 2018: 4 · 2017: 3 · 2016: 2 · 2015: 6 · 2014: 6 · 2013: 6 · 2012: 5
- FWCI
- 3.55
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Drug Abuse (R01DA017555, P50DA84718, DA017555, DA16483, R01DA016483)
- National Cancer Institute (P50CA084718)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
- Keywords
- smoking cessation, drug screening, nicotine replacement therapy, bupropion, clinical validity, nicotine withdrawal, craving, abstinence, mechanism of action
- MeSH terms
- Smoking Prevention, Administration, Cutaneous, Administration, Oral, Clinical Trials as Topic, Dose-Response Relationship, Drug, Humans, Motivation, Nicotine, Smoking, Substance Withdrawal Syndrome, Smoking Cessation, Bupropion, Antidepressive Agents, Second-Generation
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