About ORCA-2 study
Cytisinicline is a natural, plant-based drug that is being evaluated in the United States as an aid to smoking cessation. The ORCA-2 study is a randomized, placebo-controlled Phase 3 clinical trial currently being conducted to assess the effectiveness and safety of cytisinicline.
ORCA-2 is actively recruiting adults in the following cities who currently smoke cigarettes daily and intend to quit smoking.
Clinical Trial Locations:
Am I eligible to participate in the ORCA-2 study?
To qualify for further evaluation to participate in the study, you must meet the following:
To confirm you qualify for the study, study doctors will test and verify additional requirements for participation.
Why should I participate in this study?
While there’s never a bad time to quit smoking, the COVID-19 pandemic and the turning of the calendar from 2020 to 2021 are important motivators to set a quit date and identify resources that can make this attempt to quit successful.
If you meet all the qualifications to participate in the ORCA-2 study, you will receive study drug (cytisinicline, placebo, or both) during the 12-week treatment period at no cost to you. In addition, 1:1 smoking cessation counseling support, free study-related medical care, and compensation for your time and participation will be provided.
What happens if I volunteer to participate in this study?
If you qualify and decide to participate in the study, you will be randomized into one of three groups:
- One placebo tablet orally three times daily plus behavioral support for 12 weeks
- One cytisinicline tablet orally three times daily plus behavioral support for 6 weeks followed by one placebo tablet orally three times daily plus behavioral support for 6 weeks
- One cytisinicline tablet orally three times daily plus behavioral support for 12 weeks
The placebo tablet is identical in size, shape, color and packaging as the cytisinicline tablet. It contains the same components as the cytisinicline tablet except the active ingredient. Neither you nor your doctor will know whether you are receiving placebo treatment or cytisinicline.
During the study, you will be assessed for smoking cessation by self-report of abstinence with verification documented by medical tests with the doctor weekly starting at Week 2 through Week 12. Additional follow-up assessments will occur at Week 16, 20 and 24 to evaluate long-term continuous abstinence and safety. You can expect to have approximately 14 visits to the doctor’s office over the course of the study.