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Cytisinicline well tolerated with only 2.9 percent of participants discontinuing due to an adverse event.

For smokers who want to quit, six or 12 weeks of cytisinicline is efficacious for smoking cessation, according to a study published in the July 11 issue of the Journal of the American Medical Association.

Nancy A. Rigotti, M.D., from Massachusetts General Hospital in Boston, and colleagues examined the efficacy and tolerability of cytisinicline for smoking cessation when administered for six or 12 weeks versus placebo in a three-group, double-blind randomized trial. A total of 810 adults who smoked cigarettes daily and wanted to quit were randomly assigned to 3 mg of cytisinicline treatment three times daily for six or 12 weeks versus placebo (269, 270, and 271 participants, respectively), with follow-up to 24 weeks. All of the participants received behavioral support.

The researchers found that continuous abstinence rates were 25.3 versus 4.4 percent during weeks 3 to 6 and 8.9 versus 2.6 percent during weeks 3 to 24 for the six-week course of cytisinicline versus placebo (odds ratios, 8.0 and 3.7, respectively). For the 12-week course of cytisinicline versus placebo, continuous abstinence rates were 32.6 versus 7.0 percent and 21.1 versus 4.8 percent for weeks 9 to 12 and 9 to 24, respectively (odds ratios, 6.3 and 5.3, respectively). In less than 10 percent of each group, nausea, abnormal dreams, and insomnia occurred. Overall, 2.9 percent discontinued cytisinicline due to an adverse event; there were no drug-related serious adverse events reported.

“Cytisinicline reduced nicotine craving and was well tolerated by participants, who adhered to the treatment schedule at a high rate, even though the trial was conducted during the early phases of the U.S. COVID-19 pandemic,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Achieve Life Sciences, which funded the study.

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