Journal of Substance Abuse Treatment
Volume 34, Issue 2 , Pages 234-241 , March 2008

Can the blind see? Participant guess about treatment arm assignment may influence outcome in a clinical trial of bupropion for smoking cessation

  • Robert A. Schnoll, Ph.D.

      Affiliations

    • Department of Psychiatry, The University of Pennsylvania, Philadelphia, PA, USA
    • Corresponding Author InformationCorresponding author. Department of Psychiatry, University of Pennsylvania, 3535 Market Street, 4th Floor, Philadelphia, PA 19104, USA. Tel.: +1 215 746 143; fax: +1 215 746 7140.
  • ,
  • Leonard Epstein, Ph.D.

      Affiliations

    • Department of Pediatrics and Social and Preventive Medicine, University of Buffalo, Buffalo, NY, USA
  • ,
  • Janet Audrain, Ph.D.

      Affiliations

    • Department of Psychiatry, The University of Pennsylvania, Philadelphia, PA, USA
  • ,
  • Raymond Niaura, Ph.D.

      Affiliations

    • Department of Psychiatry and Human Behavior, Butler Hospital, Providence, RI, USA
  • ,
  • Larry Hawk, Ph.D.

      Affiliations

    • Department of Psychology, University of Buffalo, Buffalo, NY, USA
  • ,
  • Peter G. Shields, M.D.

      Affiliations

    • Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA
  • ,
  • Caryn Lerman, Ph.D.

      Affiliations

    • Department of Psychiatry, The University of Pennsylvania, Philadelphia, PA, USA
  • ,
  • E. Paul Wileyto, Ph.D.

      Affiliations

    • Department of Psychiatry, The University of Pennsylvania, Philadelphia, PA, USA

Received 9 November 2006 ,Revised 7 March 2007 ,Accepted 5 April 2007.

References 

  1. Ahluwalia JS, Harris KJ, Catley D, Okuyemi KS, Mayo MS. Sustained release bupropion for smoking cessation in African Americans: A randomized controlled trial. Journal of the American Medical Association. 2002;288:468–474
  2. American Psychiatric Association . Diagnostic and statistical manual of mental disorders DSM-IV. 4th ed.. 1994;Washington, DC
  3. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Controlled Clinical Trials. 2004;25:143–156
  4. Baron RM, Kenny DA. The moderator–mediator variable distinction in social psychological research: Conceptual, strategic, and statistical considerations. Journal of Personality and Social Psychology. 1986;51:1173–1182
  5. Carpenter JA. Contributions from psychology to the study of drinking and driving. Quarterly Journal of Studies on Alcohol. 1968;(Suppl 4):234–251
  6. Collins B, Wileyto P, Patterson F, Rukstalis M, Audrain-McGovern A, Kaufmann V, et al. Gender differences in smoking cessation in a placebo-controlled trial of bupropion with behavioral counseling. Nicotine and Tobacco Research. 2004;6:27–37
  7. Desbiens NA. In randomized controlled trials, should subjects in both placebo and drug groups be expected to guess that they are taking drug 50% of the time?. Medical Hypotheses. 2002;59:227–232
  8. Epstein LH, Wright SM, Paluch RA, Leddy JJ, Hawk LW, Jaroni JL, et al. Relation between food reinforcement and dopamine genotypes and its effect on food intake in smokers. American Journal of Clinical Nutrition. 2004;80:82–88
  9. Fagerström KO, Kunze M, Schoberberger R, Breslau N, Hughes JR, Hurt RD, et al. Nicotine dependence versus smoking prevalence: Comparisons among countries and categories of smokers. Tobacco Control. 1996;5:52–56
  10. Fiore MC, Bailey WC, Cohen SJ, Dorfman SF, Goldstein MG, Gritz ER, et al. Treating tobacco use and dependence. Clinical practice guideline. Rockville, MD: USDHHS; 2000;
  11. Goodwin JC. Research in psychology: Methods and design. New York: John Wiley and Sons; 1995;
  12. Guess HA, Kleinman A, Kusek JW, Engel LW. The science of the placebo. London: BMJ Books; 2002;
  13. Hall SM, Humfleet GL, Reus VI, Munoz RF, Hartz DT, Maude-Griffin R. Psychological intervention and antidepressant treatment in smoking cessation. Archives of General Psychiatry. 2002;59:930–936
  14. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: A revision of the Fagerström Tolerance Questionnaire. British Journal of Addiction. 1991;86:1119–1127
  15. Henningfield JE, Fant RV, Buchhalter A, Stitzer ML. Pharmacotherapy for nicotine dependence. CA: A Cancer Journal for Clinicians. 2005;55:281–299(quiz 322-283, 325)
  16. Hughes J, Hatsukami D, Pickens RW, Krahn D, Malin S, Luknic A. Effect of nicotine on the tobacco withdrawal syndrome. Psychopharmacology (Berl). 1984;83:82–87
  17. Hughes J, Stead L, Lancaster T. Antidepressants for smoking cessation. Cochrane Database of Systematic Reviews. 2004;CD000031:
  18. Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. New England Journal of Medicine. 1999;340:685–691
  19. Killen JD, Fortmann SP, Murphy GM, Hayward C, Arredondo C, Cromp D. Extended treatment with bupropion SR for cigarette smoking cessation. Journal of Consulting and Clinical Psychology. 2006;74:286–294
  20. Killen JD, Robinson TN, Ammerman S, Hayward C, Rogers J, Stone C, et al. Randomized clinical trial of the efficacy of bupropion combined with nicotine patch in the treatment of adolescent smokers. Journal of Consulting and Clinical Psychology. 2004;72:729–735
  21. Lerman C, Berrettini W, Pinto A, Patterson F, Crystal-Mansour S, Wileyto EP, et al. Changes in food reward following smoking cessation: A pharmacogenetic investigation. Psychopharmacology (Berl). 2004;174:571–577
  22. Lerman C, Jepson C, Wileyto EP, Epstein LH, Rukstalis M, Patterson F, et al. Role of functional genetic variation in the dopamine D2 receptor (DRD2) in response to bupropion and nicotine replacement therapy for tobacco dependence: Results of two randomized clinical trials. Neuropsychopharmacology. 2006;31:231–242
  23. Lerman C, Niaura R, Collins BN, Wileyto P, Audrain-McGovern J, Pinto A, et al. Effect of bupropion on depression symptoms in a smoking cessation clinical trial. Psychology of Addictive Behaviors. 2004;18:362–366
  24. Lerman C, Roth D, Kaufmann V, Audrain J, Hawk L, Liu A, et al. Mediating mechanisms for the impact of bupropion in smoking cessation treatment. Drug and Alcohol Dependence. 2002;67:219–223
  25. Lerman C, Shields PG, Wileyto EP, Audrain J, Hawk LH, Pinto A, et al. Effects of dopamine transporter and receptor polymorphisms on smoking cessation in a bupropion clinical trial. Health Psychology. 2003;22:541–548
  26. Lerman C, Shields PG, Wileyto EP, Audrain J, Pinto A, Hawk L, et al. Pharmacogenetic investigation of smoking cessation treatment. Pharmacogenetics. 2002;12:627–634
  27. Mooney M, White T, Hatsukami D. The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials. Addictive Behaviors. 2004;29:673–684
  28. Perkins K, Grobe J, D'Amicao D, Fonte C, Wilson A, Stiller R. Low dose nicotine nasal spray use and effects during initial smoking cessation. Experimental and Clinical Psychopharmacology. 1996;4:157–165
  29. Perkins K, Sayette M, Conklin C, Caggiula A. Placebo effects of tobacco smoking and other nicotine intake. Nicotine and Tobacco Research. 2003;5:695–709
  30. Piasecki T, Niaura R, Shadel W, Abrams D, Goldstein M, Fiore M, et al. Smoking withdrawal dynamics in unaided quitters. Journal of Abnormal Psychology. 2000;109:74–86
  31. Simon JA, Duncan C, Carmody TP, Hudes ES. Bupropion for smoking cessation: A randomized trial. Archives of Internal Medicine. 2004;164:1797–1803
  32. Society for Research on Nicotine and Tobacco. Subcommittee on Biochemical Verification . Biochemical verification of tobacco use and smoking cessation. Nicotine and Tobacco Research. 2002;4:149–159
  33. Wagena EJ, Knipschild PG, Huibers MJ, Wouters EF, van Schayck CP. Efficacy of bupropion and nortriptyline for smoking cessation among people at risk for or with chronic obstructive pulmonary disease. Archives of Internal Medicine. 2005;165:2286–2292
  34. Ward MM, Swan GE, Jack LM. Self-reported abstinence effects in the first month after smoking cessation. Addictive Behaviors. 2001;26:311–327
  35. Watson D, Clark L, Tellegen A. Development and validation of brief measures of positive and negative affect: The PANAS scales. Journal of Personality and Social Psychology. 1988;54:1063–1070
  36. Wileyto EP, Patterson F, Niaura R, Epstein L, Brown R, Audrain-McGovern J, et al. Do small lapses predict relapse to smoking behavior under bupropion treatment. Nicotine and Tobacco Research. 2004;6:357–366
  37. Wileyto EP, Patterson F, Niaura R, Epstein LH, Brown RA, Audrain-McGovern J, et al. Recurrent event, analysis of lapse and recovery in a smoking cessation clinical trial utilizing bupropion. Nicotine and Tobacco Research. 2005;7:257–268

PII: S0740-5472(07)00108-0

doi: 10.1016/j.jsat.2007.04.004

Journal of Substance Abuse Treatment
Volume 34, Issue 2 , Pages 234-241 , March 2008