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Stop smoking

Have you, or someone you know, tried to quit smoking cigarettes unsuccessfully?


While the benefits of quitting cigarette smoking are well understood, there are still 34 million adults in the United States who are current cigarette smokers. Smokers are encouraged to speak with their health care providers about options that can help them succeed in quitting, including potentially participating in the ORCA-3 clinical study, if appropriate.

The ORCA-3 study is being conducted to learn more about the effectiveness and safety of an oral medicine, cytisinicline, in combination with behavioral support in people trying to quit cigarette smoking. In this study, researchers want to find out if cytisinicline can increase the rate of quitting cigarette smoking and also assess the safety and tolerability of cytisinicline.

Who Can Participate in this Smoking Cessation Study?
To qualify, participants must (be/have):

  • Age ≥18 years
  • Current daily cigarette smokers who smoke ten or more cigarettes per day and who intend to quit smoking
  • Failed at least one previous attempt to stop smoking with or without therapeutic support
  • Willing to set a quit date within 5-7 days of starting treatment
  • Willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study

18 and over

Study Topics

Smoking cessation

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Smoking Cessation Facts

Despite the known health risks, cigarette smoking remains highly prevalent and difficult to quit.


  • Tobacco use is currently the leading worldwide cause of preventable death
  • Worldwide, over 1.1 billion people are smokers
    • Estimated that 34 million adults in US are current cigarette smokers
  • For the first time in over 20 years there has been a rise in cigarette sales
  • Tobacco kills up to half of its users
    • 7 million first-hand smoking deaths per year
    • 1.2 million from second-hand smoke
  • The highest smoking rates are people ages 25-44 and 45-64 years old
    • Approximately 90% of all smokers start before age 18
    • Nearly 14% of adults in the US aged 18 years or older smoked cigarettes in 2018
  • Other than health risks, finances are among the most motivating reasons for smokers to quit
    • On average, about 50% of current smokers smoke one pack or more in a typical day, spending ~$14 per pack of cigarettes
  • Smoking-related illness in the United States costs more than $300 billion each year
    • Nearly $170 billion for direct medical care for adults
    • More than $156 billion in lost productivity
For References click here.

About this Clinical Research Study

It is estimated that there are 34 million adults who are current cigarette smokers, and more than 16 million Americans live with a smoking-related disease.

In addition, for the first time in 20 years there has been a rise in cigarette purchases. This is combined with a growing body of evidence that suggests that there is an association between smoking and the severity of disease/death in patients with COVID-19. The Centers for Disease Control and Prevention (CDC) has identified smoking as a factor that may increase the risk of severe illness from COVID-19 for both current and former smokers.  

ORCA-3 is a Phase 3 study currently being conducted in the United States to assess the effectiveness and safety of cytisinicline, a naturally derived, investigational compound, as a smoking cessation therapy in adults who smoke cigarettes. ORCA-3 is actively recruiting adults who currently smoke ten or more cigarettes per day, intend to quit smoking, and are willing to set a quit date that is within 5-7 days of the start of treatment.

This research study is enrolling people who:

Are you over the age of 18?

Smoke 10 or more cigarettes per day and intend to quit smoking

Failed at least one previous attempt to stop smoking with or without therapeutic support

Are willing to set a quit date within 5-7 days of starting treatment

Do You Not Meet the Criteria for This Study?

You could still participate in other studies. Contact us to be added to our database and you’ll be notified about our future studies that may be right for you.