Rochester Clinical Research seeks participants for study of investigational e-cigarette cessation therapy

Rochester Clinical Research is one of the five select cities enrolling eligible participants into ORCA-V1, a U.S. Phase 2 clinical research study evaluating the effectiveness and tolerability of cytisinicline, an investigational, plant-derived treatment for e-cigarette cessation in adults who use e-cigarettes daily and intend to quit vaping.

A report showed that approximately 11 million Americans currently used e-cigarettes in 2019. While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and deliver toxic chemicals that may result in irreversible lung damage or cardiovascular disease. Currently, there are no FDA-approved e-cigarette cessation treatment options, and individuals wishing to quit vaping are left without assistance. 

In a recent study conducted by Achieve Life Sciences, Inc., approximately 73% of adult e-cigarette users responded that they intend to quit vaping within the next three to 12 months. More than half of those who intended to quit even sooner, said they would be extremely likely to try a new prescription product to help them do so. These statistics show the need for approved treatment options and the importance of trials, such as the ORCA-V1 study. 

The FDA-approved non-nicotine smoking cessation therapies, varenicline and bupropion, can improve rates of smoking cessation, but they can be associated with troublesome side effects and are not specifically approved for use in e-cigarette cessation. Additional treatment options are needed in order to help more people successfully quit vaping and reduce their e-cigarette-related health risks. 

The benefits of quitting e-cigarettes are well understood in the medical community and are quickly becoming more mainstream knowledge. Health care providers encourage e-cigarette users to make quitting a priority for themselves and to speak with their health care team about options that can help them succeed. This may include clinical trial participation if appropriate.  

ORCA-V1 is being conducted at five institutions in the United States, including Rochester Clinical Research. The study will learn more about the effectiveness and tolerability of 3.0 mg cytisinicline taken for 12 weeks in combination with behavioral support in people trying to quit vaping. Cytisinicline is a plant-derived treatment structurally similar to nicotine and is believed to aid in smoking and e-cigarette cessation by binding to the nicotine receptors in the brain.

The study is open to adults at least 18 years of age who are daily e-cigarette users, are not currently cigarette smokers, and intend to quit vaping.

Those interested in joining the study are asked to call 585-288-0890 or visit https://www.rcrclinical.com/clinical-trial/quit-e-cigarette-smoking-interest-list/.

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