Background: In 2009, FDA required black box warning re: serious neuropsych events. Manufacturers required to assess risks with RCT.
n = 8000 motivated adult smokers, at least 1 attempt to quit, >=10 cigs/day
Randomized to varenicline, buproprion, transderm nicotine or placebo for 12 weeks
All got counseling and agreed to quit within 1 week of randomization
Half of participants met criteria for at least one psych disorder (DSM-IV) but stable.
Substance abuse or unstable psych disorders excluded.
Neuropsych events (moderate or severe anxiety, depression, agitation, hostility) more common in psych cohort vs non-psych cohort (5.8 v 2.1%).
But…within each cohort, adverse event rates similar across all four treatment groups.
In both cohorts, rates of abstinence higher with varenicline than with buproprion or transderm nicotine.
Buproprion and TDN were better than placebo.
Conclusion: Varenicline and buproprion can be used safely in a wide cohort of patients, even with stable psych disease.
Lancet 2015 Apr 22