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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2015, Progress in Neuro-Psychopharmacology and Biological PsychiatryCitation Excerpt :Numerous neuropsychiatric adverse events during varenicline treatment have been reported, including suicidal ideation and depressed mood and in a currently published paper authors demonstrated that the second most frequent drug with reports on depression and suicide was the varenicline in the UK between 1998 and 2011 (Pirmoradi et al., 2008; Thomas et al., 2014; Tonstad et al., 2010). Other studies, however, did not find evidence for these neuropsychiatric side effects (Cinciripini et al., 2013; Garza et al., 2011; Thomas et al., 2013). Nevertheless, a recent study suggests that varenicline may have a protective effect on depressed mood (Cinciripini et al., 2013); furthermore, α4β2 nAChR as potential antidepressant targets have been implicated (Yu et al., 2014).
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2023, Cochrane Database of Systematic ReviewsRisk of neuropsychiatric adverse events associated with varenicline treatment for smoking cessation among Dutch population: A sequence symmetry analysis
2022, Pharmacoepidemiology and Drug Safety