Ongoing Research of Cytisinicline for Addiction

A second Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial of Cytisinicline in Adult Smokers. Expected to Initiate in 1’H 2022.

Design

The ORCA-3 trial mirrors the Phase 3 ORCA-2 trial and is designed to obtain additional safety and efficacy data.

  • Placebo-controlled & double-blind
  • 3 treatment arms: Placebo vs 6 or 12 weeks cytisinicline
  • Cytisinicline treatment for 6 or 12 weeks

    • Does longer treatment lead to better efficacy?
    • Does continued treatment prevent early relapses?
  • Primary Endpoint: 4-week continuous abstinence ON treatment
  • Follow up to 6 months
Laburnum
ORCA-2