Clinical trial shows that cytisinicline can help people quit vaping

Eleven million U.S. adults use e-cigarettes to vape nicotine, and about half of them say that they want to stop, but many have trouble doing so because nicotine is an addictive drug.

A plant-based medication called cytisinicline may be an effective therapy to help them stop vaping, according to the results of a new clinical trial co-led by an investigator from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system. The trial’s findings are published in JAMA Internal Medicine.

In the double-blind randomized clinical trial, 160 adults who vaped nicotine but did not currently smoke cigarettes were assigned to take either oral cytisinicline or placebo tablets for 12 weeks. All participants had weekly behavioral support to stop vaping.

At the end of treatment, participants receiving cytisinicline were more than twice as likely as those receiving placebo to have successfully abstained from vaping for weeks 9 to 12 (31.8% vs 15.1%, p=.04). The drug was well tolerated, with comparable rates of side effects between the groups. The study was conducted at Massachusetts General Hospital and 4 other sites.

“No medication has been approved by the FDA for vaping cessation in the United States,” said lead author Nancy A. Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center and a professor of medicine at Harvard Medical School. “Our study indicates that cytisinicline might be an option to fill this gap and help adult vapers to stop using e-cigarettes.”

The team tested cytisinicline for vaping because the drug binds to nicotine receptors on brain cells. In their previous clinical trial, the research team found that cytisinicline helped people to quit smoking traditional cigarettes.  They hypothesized that it might also help people to stop vaping nicotine. “The results of our study need to be confirmed in a larger trial with longer follow-up,” said Rigotti, “but they are promising.”

Authorship: Nancy A. Rigotti, MD; Neal L. Benowitz, MD; Judith J. Prochaska, PhD, MPH; Daniel F. Cain, BSc; Juli Ball, MS; Anthony Clarke, PhD; Brent A. Blumenstein, PhD; and Cindy Jacobs, PhD, MD.

Disclosures: Dr. Rigotti has consulted with Achieve Life Sciences and MGH has received research grants for clinical trials of cytisinicline for smoking cessation. Disclosure forms provided by the authors are available with the full text of this article at JAMA Internal Medicine.

Funding: The trial was funded by a grant from the National Institute of Drug Abuse and by Achieve Life Sciences, a pharmaceutical company that is developing cytisinicline as a treatment for nicotine dependence.

Paper cited: Rigotti NA et al. “Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes—The ORCA-V1 Randomized Clinical Trial.” JAMA Internal Medicine
DOI: 10.1001/jamainternmed.2024.1313