Cytisinicline Effective in Aiding Smoking Cessation

In the first large-scale clinical trial of cytisinicline in the United States, a team of researchers has found that the plant-based alkaloid smoking cessation medication is effective and well tolerated in adults who would like to be treated for nicotine dependence.

For their study, Rigotti and colleagues conducted a three-group, double-blind, placebo-controlled, randomized study where they compared two durations of treatment of cytisinicline vs placebo. Participants received treatment or placebo for 6 or 12 weeks, with follow-up to 24 weeks post-treatment. The study included a total of 810 adults who smoked cigarettes daily and were interested in quitting. A total of 17 sites in the US were used for the trial from October 2020 to December 2021.

Participants were randomized 1:1:1 to cytisinicline. In the first cohort, participants received 3 mg of cytisinicline, three times daily for 12 weeks (n = 270). The second group received 3 mg cytisinicline, three times daily for 6 weeks then placebo three times daily for 6 weeks (n = 269). The final cohort received placebo three times daily for 12 weeks (n = 271).

Of the total participants, 618 individuals completed the trial. For the participants in the 6-week course of cytisinicline vs placebo, the researchers found that continuous abstinence rates were 25.3% vs 4.4% during weeks 3 to 6, and 8.9% vs 2.6% during weeks 3 to 24. And for participants who received the 12-week course of cytisinicline vs placebo, continuous abstinence rates were 32.6% vs 7.0% for weeks 9 to 12 and 21.1% vs 4.8% during weeks 9 to 24.

Additionally, adverse events were reported, which included nausea, abnormal dreams, and insomnia. The adverse event occurred in less than 10% of each group. Sixteen participants (2.9%) stopped taking cytisinicline due to an adverse event, but no drug-related serious adverse event occurred.

Currently, cytisinicline is not licensed in the US, but is used in some European countries to help smoking cessation in individuals.

“Both 6- and 12-week cytisinicline schedules, with behavioral support, demonstrated smoking cessation efficacy and excellent tolerability, offering new nicotine dependence treatment options,” the researchers concluded.

Reference:

Rigotti NA, Benowitz NL, Prochaska J, et al. Cytisinicline for smoking cessation. JAMA. 2023;330(2):152-160. doi:10.1001/jama.2023.10042