Cytisinicline, a plant-based alkaloid, significantly increased vaping cessation rates with participants achieving continuous abstinence in the last month of treatment, according to the study.

The ORCA-V1 Randomized Clinical Trial, published in JAMA Internal Medicine, evaluated cytisinicline's efficacy and safety as a pharmacotherapy for vaping cessation. The double-blind, placebo-controlled trial involved 160 adults who used nicotine e-cigarettes daily but did not smoke cigarettes. Researchers randomly assigned participants to receive either cytisinicline (3 mg, 3 times daily) or a placebo, with weekly behavioral support, over a 12-week period.

The primary outcome showed a continuous abstinence from vaping during weeks 9-12 of the trail. The results also demonstrated that 31.8% of participants in the cytisinicline group achieved abstinence, compared with15.1% in the placebo group, with an odds ratio of 2.64 (95% CI, 1.06-7.10; P = 0.04). Although abstinence continued through 4 additional post-treatment weeks (23.4% for the cytisinicline group vs 13.2% for the placebo group), the researchers noted figures did not reach statistical significance.

According to the findings, cytisinicline was well tolerated with only 3.8% of participants discontinuing due to adverse effects. "For individuals seeking to quit vaping, cytisinicline might fill the existing gap in pharmacologic treatments and enhance the emerging evidence of efficacy of behavioral treatments for vaping cessation," noted the researchers.

The findings highlight the importance of developing effective vaping cessation therapies, particularly among young adults. Some are successful on their own, but many need help to quit vaping, they noted. 

Prior studies have shown limited support for pharmacotherapies in vaping cessation, making cytisinicline's positive results notable.

“While these findings warrant confirmation in a phase 3 trial with a larger sample size and longer follow-up, they are consistent with the demonstrated efficacy of cytisinicline for cigarette smoking cessation," the researchers concluded.

The study received funding from the National Institute of Drug Abuse and Achieve Life Sciences. Some of the study authors declared receiving personal fees and grants from Achieve Life Sciences outside the submitted work.