Pre-treatment factors that increase smokers’ risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown. So, to identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES. However, a prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial. Smokers without/with histories of, or current clinically stable, psychiatric disorders including mood, anxiety, and psychotic disorders.

Smokers with or without mental health conditions

Bupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper); and placebo for 12 weeks with 12-week non-treatment follow-up. Primary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression.

So, three factors predict clinically significant neuropsychiatric adverse events (NPSAEs) in smokers with or without mental health conditions; who use cessation pharmacotherapy, according to a study published online in the Journal of General Internal Medicine. However, Robert M. Anthenelli; and colleagues evaluated data from 3,984 smokers; without a history of psychiatric disorders and 4,050 with histories of or current clinically stable psychiatric disorders, including mood, anxiety, and psychotic disorders. So, patients had been randomly assigned to bupropion or varenicline versus active control and placebo for 12 weeks with 12-week nontreatment follow-up.

A paid expert witness

The researchers found that the incidence of moderate-to-severe NPSAEs was higher among smokers; in the psychiatric cohort versus the nonpsychiatric cohort. Regardless of carrying a psychiatric diagnosis; increased risk for experiencing clinically significant NPSAEs; when quitting was; predicted by current symptoms of anxiety; previous history of suicidal ideation and/or behavior; and being of white race versus black race. Younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity predicted a greater risk for NPSAEs among smokers with psychiatric disorders.

“[People with mental illness] have a harder time quitting smoking and are disproportionately; affected by tobacco-related diseases and premature death;” Anthenelli said in a statement. “Just because they have mental illness, however, does not mean they should not consider a smoking cessation drug as the risk of disease from long-term smoking is much greater.” Several authors disclosed financial ties to pharmaceutical companies, including Pfizer and GlaxoSmithKline, which funded the trial, and one author has served as a paid expert witness in litigation against tobacco companies.