Investigational Treatment May Help Adult Cigarette Smokers Who Want to Quit


Posted: May 25, 2022 | Word Count: 479

Have you, or someone you know, tried to quit smoking cigarettes unsuccessfully? If so, you’re not alone. Research from the Centers for Disease Control (CDC) found that 70% of adult cigarette smokers in the United States wanted to quit, yet only 7% are successful in doing so.[1] While there’s never a bad time to quit smoking, the start of a new season can be an important motivator to set a quit date and identify resources that can make this attempt to quit successful.

Researchers from many clinical centers across the United States, are helping to evaluate an investigational therapy called cytisinicline, in combination with behavioral support, as a new smoking cessation therapy. The clinical study, known as ORCA-3, is a Phase 3 trial to evaluate the safety and efficacy of cytisinicline in adults who smoke ten or more cigarettes per day and have at least one unsuccessful quit attempt with or without therapeutic support.

While the benefits of quitting cigarette smoking are well understood, there are still 30 million adults in the United States who are current cigarette smokers[2]. 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.

Am I eligible to participate in the ORCA-3 study?

To qualify for ORCA-3, 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
  • Doctors will check other requirements to confirm that participants qualify for this study.

The 31st of May is World No Tobacco Day, an annual celebration organized by the World Health Organization that informs the public on the dangers of tobacco use and what steps people can take to quit smoking. For this year’s World No Tobacco Day, make it your year to quit.

If you or someone you know is interested or would like more information on the study, please visit https://orca-3.com.


[1] U.S. Food & Drug Administration. Quitting Smoking: Closer with Every Attempt. Available at: https://www.fda.gov/tobacco-products/health-information/quitting-smoking-closer-every-attempt.

[2] Cornelius ME, Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco Product Use Among Adults — United States, 2020. MMWR Morb Mortal Wkly Rep 2022; 71:397–405.

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