title: Perceived medication assignment during a placebo-controlled laboratory study of varenicline: temporal associations of treatment expectancies with smoking-related outcomes.
abstract: BACKGROUND
  Expectancies regarding treatment assignment may influence outcomes in placebo-controlled trials above and beyond actual treatment assignment. For smoking pharmacotherapies, guessing enrollment in the active medication treatment is associated with higher abstinence rates. However, placebo-controlled trials of smoking pharmacotherapies rarely assess perceived treatment assignment and those that do only collect this information after reaching full dosage.
  
  
  OBJECTIVE
  To determine the temporal relationship between treatment expectancies and smoking-related variables, we assessed the impact of treatment guess during a placebo-controlled laboratory study of varenicline on measures of craving, smoking reward, and smoking reinforcement. We hypothesized that treatment guess at mid-titration would influence smoking-related measures at full dosage, above and beyond actual medication effects. We also explored factors related to guess stability and differences in blind fidelity between mid-drug titration and full dosage.
  
  
  METHODS
  Eighty-eight participants completed laboratory assessments at baseline, mid-titration, and full dosage that involved self-report and behavioral measures of tonic craving, cue-provoked craving, smoking reward, and smoking reinforcement. Participants guessed treatment assignment at mid-titration and full dosage.
  
  
  RESULTS
  Generalized linear models confirmed that, beyond actual treatment assignment, treatment guess improved model fit for both self-report and behavioral smoking-related measures. Further, accuracy of treatment guess improved from titration to full dosage, and specific demographic factors (e.g., gender, race) were associated with type of treatment guess and guess stability across time.
  
  
  CONCLUSIONS
  These results reinforce the importance of assessing perceived treatment assignment repeatedly during placebo-controlled trials and suggest that treatment expectancies during titration can affect outcomes once full dosage has been reached.
authors.affiliation: Department of Psychology, University of South Florida, Tampa, FL, USA.
authors.forename: John B
authors.initials: JB
authors.lastname: Correa
authors.forename: Bryan W
authors.initials: BW
authors.lastname: Heckman
authors.forename: Nicole S
authors.initials: NS
authors.lastname: Marquinez
authors.forename: David J
authors.initials: DJ
authors.lastname: Drobes
authors.forename: Marina
authors.initials: M
authors.lastname: Unrod
authors.forename: Richard G
authors.initials: RG
authors.lastname: Roetzheim
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Brandon
mesh_terms: D000328:Adult; D001552:Benzazepines / Q000008:administration & dosage / Q000494:pharmacology*; D003463:Cues; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000494:pharmacology*; D010465:Perception; D015990:Placebo Effect; D011446:Prospective Studies; D011810:Quinoxalines / Q000008:administration & dosage / Q000494:pharmacology*; D012054:Reinforcement, Psychology; D012201:Reward; D012907:Smoking / Q000188:drug therapy* / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D016896:Treatment Outcome; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline