Cytisinicline for Smoking Cessation: The ORCA Phase 3 Replication Randomized Clinical Trial.

ABSTRACT:

Importance

New smoking cessation medication options are needed. Cytisinicline, a partial agonist at α4β2 nicotinic acetylcholine receptors, has demonstrated smoking cessation efficacy in 1 US trial. Additional evidence is needed.

Objective

To reproduce the findings of the efficacy and tolerability of cytisinicline compared with placebo for smoking cessation and to test its effect on nicotine craving as a mechanism of action.

Design, settings, and participants

This was a 3-group double-blind, placebo-controlled phase 3 replication randomized clinical trial (ORCA-3) conducted at 20 clinical trial sites in the US from January 2022 to March 2023. It compared 6 and 12 weeks of a novel cytisinicline regimen to placebo among adults who smoked 10 or more cigarettes daily and

SUBMITTER: Rigotti NA 

PROVIDER: S-EPMC12012700 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature