Varenicline: No Harm, but Little Benefit

Varenicline, a partial agonist of the nicotinic acetylcholine receptor, is a widely advertised smoking-cessation drug that some postmarketing surveillance reports have linked to adverse neuropsychiatric events. These researchers randomized 110 highly dependent smokers (of 857 initially screened) without psychiatric histories to receive varenicline (1 mg) or placebo twice daily for 12 weeks. The manufacturer funded the trial, which was conducted at a commercial site, and partly funded the editorial work on the manuscript.

For the first 2 weeks, participants were permitted to smoke. For weeks 2 to 4, they were hospitalized, allowing for close observation of abstinence and withdrawal symptoms, although participants could go outside to smoke if …