Cytisinicline effective for e-cigarette cessation

Key takeaways:

• 23.4% of participants reported continuous e-cigarette abstinence up to 4 weeks after cytisinicline.
• Cytisinicline was well tolerated; 3.8% of participants discontinued treatment due to an adverse event.

Cytisinicline was associated with a greater rate of nicotine-containing e-cigarette cessation compared with placebo during 12 weeks of treatment and up to 4 weeks posttreatment, according to results from the phase 2 ORCA-VI trial.

“Evidence from clinical trials to guide vaping cessation treatment, especially pharmacotherapy, is limited,” Nancy A. Rigotti, MD, a professor at Harvard Medical School and director of Massachusetts General Hospital’s Tobacco Research and Treatment Center, and colleagues wrote in JAMA Internal Medicine. “With nicotine-containing e-cigarette use rising, safe and effective treatments to help individuals who wish to stop vaping is an urgent need.”

Healio previously reported on a study Rigotti and colleagues did last year, which found that almost 33% of adult cigarette smokers who received the plant-based alkaloid cytisinicline were abstinent toward the end of a 12-week treatment course.

In the latest study, the researchers conducted a double-blind, placebo-controlled randomized clinical trial at five U.S. sites with adults who vaped nicotine daily and sought to quit.

In the trial — conducted from July 2022 to February 2023 — participants received either three daily doses of 3 mg cytisinicline (n = 107) or placebo (n = 53) for 12 weeks. Rigotti and colleagues then followed up with participants during the 4 weeks posttreatment.

Overall, continuous e-cigarette abstinence occurred in 31.8% of cytisinicline participants and 15.1% of placebo participants (OR = 2.64; 95% CI, 1.06-7.1) during weeks 9 to 12 of treatment.

Meanwhile, during weeks 9 to 16, continuous e-cigarette abstinence occurred in 23.4% of cytisinicline participants and 13.2% of placebo participants (OR = 2; 95% CI, 0.82-5.32).

Cytisinicline was also well tolerated by participants, with only 3.8% discontinuing it after experiencing adverse events.

The researchers found no evidence that the effects differed by age, sex, history of e-cigarette smoking, e-cigarette dependence, age of vaping initiation or e-liquid flavor.

Rigotti and colleagues pointed out that 7.5% of participants met the criteria for possible cigarette smoking during the last 4 weeks of treatment. However, “cytisinicline used for vaping cessation does not appear to increase the risk of relapse to smoking or dual use, a finding consistent with cytisinicline’s demonstrated efficacy for smoking cessation and its hypothesized method of action as a partial nicotine receptor agonist that blocks the reinforcement of smoking,” they wrote.

They added that the findings warrant further research with larger sample sizes and longer posttreatment follow-ups.

The study was limited in its overall generalizability and ability to detect differences in subgroups, according to the researchers.

“The intensity of behavioral support and attention to treatment adherence provided likely exceeds what health care settings typically provide,” Rigotti and colleagues noted.

Still, “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,” they concluded.