Cross-validation of a new procedure for early screening of smoking cessation
medications in humans.
Author(s): Perkins KA, Lerman C, Fonte CA, Mercincavage M, Stitzer ML, Chengappa KN, Jain A.
Affiliation(s): Department of Psychiatry, University of Pittsburgh School of Medicine,
Pittsburgh, Pennsylvania, USA. perkinska@upmc.edu
Publication date & source: 2010, Clin Pharmacol Ther. , 88(1):109-14
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.
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