About the Study

Are you highly motivated to quit smoking? Tobacco smoking contributes to 7 million premature worldwide deaths each year. It is highly addictive and 95% of people who try to quit without help, fail within 6 months. Nicotine is primarily responsible for the addictive properties of smoking since it is absorbed quickly with each cigarette. Tobacco smoke also contains a deadly mix of 7,000 chemicals; about 70 can cause cancer according to the CDC.

Quitting smoking greatly reduces the risk of early death or developing smoking-related diseases including lung cancer (and other types of cancer), COPD, heart disease, stroke and more.

Rochester Clinical Research is currently conducting a study to help volunteers quit smoking. The study will use a drug called Cytisine, a plant-based drug and has been used for smoking cessation since the 1960’s in Easter and Central Europe. The hope is to have an overall reduction in cigarette smoking during the study treatment period.

ORCA-2 (NCT04576949) is a U.S. Phase 3 study currently being conducted to assess the effectiveness and safety of cytisinicline, a plant-based compound, as a smoking cessation therapy in adults who smoke cigarettes. Data from previous studies support the potential of cytisinicline as a smoking cessation therapy that is at least as effective as FDA-approved agents and may offer an improved side-effect profile. ORCA-2 is actively recruiting adults who currently smoke cigarettes daily, intend to quit smoking, and are willing to set a quit date that is within 5-7 days of the start of treatment.

If you are over the age of 18 and are a daily cigarette smoker, you may qualify. Space is limited and RCR will be seeking highly motivated individuals for this study.

Why should you participate in this study?

  • While there’s never a bad time to quit smoking, the COVID-19 pandemic and the calendar turning from 2020 to 2021 are important motivators to set a quit date and identify resources that can make this attempt to quit successful.
  • COVID-19 is just the most recent addition to a long and growing list of conditions for which smoking is a significant risk factor, including cardiovascular disease, stroke, a dozen different types of cancer, chronic obstructive pulmonary disease, type 2 diabetes, rheumatoid arthritis, and reduced male and female fertility.
  • Prescription medication and counseling have been shown to improve quit rates, including them in your quitting resolution may help you achieve your quitting goal.
  • The ORCA-2 study is a U.S. clinical study currently being conducted to assess the effectiveness and safety of cytisinicline as a smoking cessation therapy in adults who smoke cigarettes. Cytisinicline is a naturally occurring plant-based compound believed to reduce the severity of nicotine withdrawal symptoms, compared with placebo (an inactive substance) in improving abstinence from cigarettes.
  • Cytisinicline at a lower dose and different administration schedule has already been used by 20 million smokers in Eastern and Central Europe to help with smoking cessation and is now being evaluated for use in the U.S. through the ORCA-2 study.
  • If you meet the qualifications to participate in the ORCA-2 study, you may receive: the study drug cytisinicline, placebo, or both along with evaluation by physicians and study-related tests at no cost to you. You will also be partially compensated for your travel and time.

The study will last approximately 28 weeks with 17 visits to our office.  Compensation is available for time and travel for those who qualify. Study related care is available to participants at no cost and health insurance is not required nor needed.

Qualifications

  • Over the age of 18 years old
  • A daily cigarette smoker (at least 10 cigarettes per day)
  • Very motivated to quit smoking within 5-7 days of starting the study
  • Please note, other conditions may apply