title: Selection criteria limit generalizability of smoking pharmacotherapy studies differentially across clinical trials and laboratory studies: A systematic review on varenicline.
abstract: The selection criteria used in clinical trials for smoking cessation and in laboratory studies that seek to understand mechanisms responsible for treatment outcomes may limit their generalizability to one another and to the general population.
  
  
  
  We reviewed studies on varenicline versus placebo and compared eligibility criteria and participant characteristics of clinical trials (N=23) and laboratory studies (N=22) across study type and to nationally representative survey data on adult, daily USA smokers (2014 National Health Interview Survey; 2014 National Survey on Drug Use and Health).
  
  
  
  Relative to laboratory studies, clinical trials more commonly reported excluding smokers who were unmotivated to quit and for specific medical conditions (e.g., cardiovascular disease, COPD), although both study types frequently reported excluding for general medical or psychiatric reasons. Laboratory versus clinical samples smoked less, had lower nicotine dependence, were younger, and more homogeneous with respect to smoking level and nicotine dependence. Application of common eligibility criteria to national survey data resulted in considerable elimination of the daily-smoking population for both clinical trials (≥47%) and laboratory studies (≥39%). Relative to the target population, studies in this review recruited participants who smoked considerably more and had a later smoking onset age, and were under-representative of Caucasians.
  
  
  
  Results suggest that selection criteria of varenicline studies limit generalizability in meaningful ways, and differences in criteria across study type may undermine efforts at translational research. Recommendations for improvements in participant selection and reporting standards are discussed.
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA.
authors.forename: Courtney A
authors.initials: CA
authors.lastname: Motschman
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA.
authors.forename: Julie C
authors.initials: JC
authors.lastname: Gass
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA; VA Center for Integrated Healthcare, VA Western NY Medical Center, Buffalo, NY, 14215, USA.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Wray
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Germeroth
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
authors.forename: Nicolas J
authors.initials: NJ
authors.lastname: Schlienz
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA.
authors.forename: Diana A
authors.initials: DA
authors.lastname: Munoz
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA; Department of Psychology, University of Central Florida, Orlando, FL, 32816, USA.
authors.forename: Faith E
authors.initials: FE
authors.lastname: Moore
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA; Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, 15213, USA.
authors.forename: Jessica D
authors.initials: JD
authors.lastname: Rhodes
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA.
authors.forename: Larry W
authors.initials: LW
authors.lastname: Hawk
authors.affiliation: Department of Psychology, University at Buffalo, The State University of New York, Park Hall, Buffalo, NY, 14260, USA. Electronic address: stiffany@buffalo.edu.
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Tiffany
mesh_terms: D000328:Adult; D016642:Bupropion / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D007753:Laboratories / Q000592:standards; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage; D018722:Nicotinic Agonists / Q000627:therapeutic use; D018579:Patient Selection; D012907:Smoking / Q000188:drug therapy* / Q000453:epidemiology; D016540:Smoking Cessation / Q000379:methods*; D000068580:Varenicline / Q000627:therapeutic use*
chemical_list: D018722:Nicotinic Agonists; D016642:Bupropion; D009538:Nicotine; D000068580:Varenicline
keywords: Cessation; Generalizability; Smoking; Varenicline