Participants, investigators, and research personnel were masked to treatment assignments. Randomisation was computer generated (1:1:1:1 ratio). Participants were motivated-to-quit smokers with and without psychiatric disorders who received brief cessation counselling at each visit. We did a randomised, double-blind, triple-dummy, placebo-controlled and active-controlled (nicotine patch 21 mg per day with taper) trial of varenicline (1 mg twice a day) and bupropion (150 mg twice a day) for 12 weeks with 12-week non-treatment follow-up done at 140 centres (clinical trial centres, academic centres, and outpatient clinics) in 16 countries between Nov 30, 2011, and Jan 13, 2015. We compared the relative neuropsychiatric safety risk and efficacy of varenicline and bupropion with nicotine patch and placebo in smokers with and without psychiatric disorders. Their efficacy relative to nicotine patch largely relies on indirect comparisons, and there is limited information on safety and efficacy in smokers with psychiatric disorders. Substantial concerns have been raised about the neuropsychiatric safety of the smoking cessation medications varenicline and bupropion.
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