Archival ReportA Double-Blind Randomized Placebo-Controlled Pilot Study of Neuropsychiatric Adverse Events in Abstinent Smokers Treated with Varenicline or Placebo
Section snippets
Study Design and Participants
This randomized, double-blind, placebo-controlled pilot study enrolled smokers at a single United States Phase I investigational center from September 2008 to August 2009. The trial was conducted in accordance with the Declaration of Helsinki (22) and in compliance with the institutional review board for the study site (California IRB, Inc., Pasadena, California) and the International Conference on Harmonisation and Good Clinical Practice Guidelines (23).
Adult smokers (aged 18–75 years) who
Results
Overall, 857 smokers were screened for possible participation in this study, and 110 were randomized in a 1:1 ratio to the varenicline (n = 55) and placebo (n = 55) treatment groups (Figure S1 in Supplement 1). More varenicline participants than placebo participants discontinued treatment (16 vs. 6 participants, respectively). Most of the difference between treatment groups was seen in the category of “lost to follow-up.” Study sites were instructed to continue attempting to contact
Discussion
This study was an exploratory, unpowered, pilot study in a population of smokers with no history of preexisting psychiatric disorders, suicidal behaviors, or suicidal ideation who were highly nicotine-dependent (Fagerström Test for Nicotine Dependence score > 5).
The most common AE observed during the study in the varenicline group was nausea, consistent with other published studies of varenicline (1, 2, 3, 4). All NPAEs in this study were comparable between groups, with the exception of
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