New Findings on Cytisinicline Treatment for Quitting E-Cigarettes, with Nancy Rigotti, MD

In a recent multisite randomized clinical trial known as ‘ORCA-V1,’ 160 adults who used nicotine e-cigarettes (vaping) but not cigarettes were treated for 12 weeks with cytisinicline, a plant-based alkaloid designed to reduce nicotine dependence by targeting nicotinic acetylcholine receptors, or a placebo. Both the treatment and placebo arms received behavioral support.¹

Nancy A. Rigotti, MD, a study investigator, spoke with HCPLive on her team’s findings, noting that the treatment was well tolerated and led to substantially more continuous abstinence from vaping compared to those in the placebo group within the final 4 weeks of drug treatment (31.8% versus 15.1%, respectively).

“What we know is that an increasing number of adults, especially young adults are using e-cigarettes, they're vaping nicotine, so I'm gonna use those terms interchangeably,” Rigotti explained. “...What we know is that a lot of them don't want to be doing it and realize they're nicotine addicted, so they'd like to stop.”

Rigotti noted that some studies indicate that as many as half of those who vape are attempting to quit every year but a lot of them are having trouble. While there is research suggesting the benefits of text messaging programs and behavioral support, as well as stories of the effectiveness of varenicline (Chantix) for vaping cessation, Rigotti noted there is no data to prove that these are effective.

“Cytisinicline is this new product that we have that is being developed in the United States for smoking cessation,” Rigotti said. “It's not FDA-approved at this point but it has been available for decades as a consumer product in eastern and central Europe…So it's widely used, but it's not available in the US and it works in the same way as Chantix does in the brain to help make help cure nicotine addiction, and make it easier for people to stop whatever way they're getting nicotine.”

Rigotti noted that the difference between the treatment arm and the placebo arm was about 32% of people who got cytisinicline quit and were not vaping for the last 4 weeks of the trial, more than double the 15% of those in the placebo arm. However, there were some developments afterward which suggest the need for larger trials.

“Each week, there were more people who were not vaping when we looked at every single week,” Rigotti said. “Now we did follow it up 4 weeks after we stopped giving the medicine and we found that there was relapse in both groups, but more in the cytisinicline group. So 4 weeks later, which was Week 16. The difference was not statistically significant, but there was still a considerable difference and we interpreted that to say that a lot of it was the sample size issue. We had a small trial.”

While the use of varenicline for quitting cigarettes has been demonstrated in prior research, more data may be warranted regarding the use of cytisinicline for vaping.²

For additional information on the study results, view the full interview with Rigotti posted above.

The quotes contained in this interview summary were edited for clarity. Rigotti has provided consultation to and received a research grant from Achieve Life Sciences.

References

1. ^{Rigotti NA, Benowitz NL, Prochaska JJ, et al. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. JAMA Intern Med. Published online May 06, 2024. doi:10.1001/jamainternmed.2024.1313.}
2. ^{Harris E. Systematic Review Finds the Most Effective Smoking Cessation Aids. JAMA. 2023;330(15):1421–1422. doi:10.1001/jama.2023.18742.}