JAMA Intern Med

Cytisinicline effective for smoking cessation in phase III trial

April 23, 2025

Cytisinicline can safely help smokers quit, with benefits extending through 24 weeks.

Study details: The ORCA-3 trial evaluated the efficacy and tolerability of cytisinicline for smoking cessation at 20 U.S. sites from 2022 to 2023 and included 792 adults who smoked ≥10 cigarettes daily and sought to quit. Participants were randomized to receive 3 mg cytisinicline tid for 12 weeks, 3 mg cytisinicline tid for 6 weeks followed by placebo for 6 weeks, or placebo for 12 weeks, with a follow-up period of 24 weeks. All groups received behavioral support.

Results: Cytisinicline regimens demonstrated significantly higher continuous smoking abstinence rates compared with placebo. The drug increased biochemically confirmed abstinence nearly threefold compared with placebo when taken for 6 weeks (14.8% vs. 6% during weeks 3-6; odds ratio [OR] 2.9, P<0.001) and more than fourfold when taken for 12 weeks (30.3% vs. 9.4% in weeks 9-12; OR 4.4, P<0.001).

Source:

Rigotti NA, et al. (2025, April 21). JAMA Intern Med. Cytisinicline for Smoking Cessation: The ORCA Phase 3 Replication Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40257755/