Cytisinicline for Smoking Cessation: A Randomized Clinical Trial.

ABSTRACT:

Importance

Cytisinicline (cytisine) is a plant-based alkaloid that, like varenicline, binds selectively to α4β2 nicotinic acetylcholine receptors, which mediate nicotine dependence. Although not licensed in the US, cytisinicline is used in some European countries to aid smoking cessation, but its traditional dosing regimen and treatment duration may not be optimal.

Objective

To evaluate the efficacy and tolerability of cytisinicline for smoking cessation when administered in a novel pharmacokinetically based dosing regimen for 6 or 12 weeks vs placebo.

Design, setting, and participants

A 3-group, double-blind, placebo-controlled, randomized trial (ORCA-2) compared 2 durations of cytisinicline treatment (6 or 12 weeks) vs placebo, with follow-up to 24 weeks, among 810

SUBMITTER: Rigotti NA 

PROVIDER: S-EPMC10336611 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature