Proposed Nicotine Vaping and E-Cigarette Cessation Trial
ORCA-V1 will be a multi-center, double-blind, randomized, placebo-controlled, Phase 2 study conducted in male or female adults who are daily nicotine e-cigarette users only, who intend to try to quit vaping and willing to set a quit date that is within 7-14 days from the start of cytisinicline treatment.
A total of approximately 150 subjects will be randomly assigned to one of two arms:
- Arm A, 12 weeks cytisinicline + behavior support: N=100
- Arm B, 12 weeks of placebo+ behavior support: N=50
The initiation of this trial is subject to grant funding approval.
Achieve has retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding to evaluate the potential use of cytisinicline in vapers and e-cigarette users. Achieve and FreeMind have conducted a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by grant production and submission, to further the clinical development of cytisinicline in this growing population.