title: Cross-validation of a new procedure for early screening of smoking cessation medications in humans.
abstract: Brief procedures for evaluating medication efficacy may reveal which candidate drugs warrant further testing in clinical trials and which do not. We previously carried out a study of smoking abstinence, involving the nicotine patch, and established the sensitivity of our procedure. In this study, we sought to cross-validate our earlier work by comparing short-term smoking abstinence due to varenicline (relative to placebo) in smokers with high intrinsic quit interest (n = 57) and those with low intrinsic quit interest (n = 67). All the subjects were randomly assigned to either abstinence reinforcement ($12/day) or no reinforcement. In a crossover design, all the subjects participated in two 3-week phases: ad libitum smoking (week 1), dose run-up of varenicline (1.0 mg b.i.d.) or placebo (week 2), and quit attempt on medication verified daily by carbon monoxide <5 ppm (week 3). As with the nicotine patch in the previous study, varenicline (relative to placebo) increased abstinence more effectively in those with high intrinsic quit interest than in those with low quit interest but did not affect abstinence due to reinforcement. These data confirm the feasibility of a brief, sensitive test of the efficacy of cessation medications in smokers with high quit interest.
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. perkinska@upmc.edu
authors.forename: K A
authors.initials: KA
authors.lastname: Perkins
authors.forename: C
authors.initials: C
authors.lastname: Lerman
authors.forename: C A
authors.initials: CA
authors.lastname: Fonte
authors.forename: M
authors.initials: M
authors.lastname: Mercincavage
authors.forename: M L
authors.initials: ML
authors.lastname: Stitzer
authors.forename: K N R
authors.initials: KN
authors.lastname: Chengappa
authors.forename: A
authors.initials: A
authors.lastname: Jain
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D004353:Drug Evaluation, Preclinical; D005260:Female; D006801:Humans; D008297:Male; D009042:Motivation; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012107:Research Design; D012907:Smoking / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods*; D011795:Surveys and Questionnaires; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D009538:Nicotine; D000068580:Varenicline