Cytisinicline for vaping cessation turns in promising result in phase II trial

Treatment with cytisinicline for 12 weeks, in addition to behavioural support, is well tolerated and appears to help e-cigarette users to quit vaping, according to the results of the phase II ORCA-V1 trial.

The trial included 160 adults (mean age 33.6 years, 51.9 percent female, 71.9 former smokers with ≥100 lifetime cigarettes) who vaped nicotine daily, sought to quit, and did not currently smoke cigarettes. These participants were randomly assigned to receive cytisinicline 3 mg, taken 3 times daily (n=107) or placebo (n=53) for 12 weeks. All participants received weekly behavioural support.

A total of 131 participants (81.9 percent) completed the trial. The primary outcome of biochemically verified continuous e-cigarette abstinence during the last 4 weeks of treatment (weeks 9–12) was achieved by significantly more participants in the cytisinicline group than in the placebo group (31.8 percent vs 15.1 percent; odds ratio [OR], 2.64, 95 percent confidence interval [CI], 1.06–7.10; p=0.04).

The proportion of patients who achieved continuous e-cigarette abstinence through 4 weeks post-treatment (weeks 9–16) was also higher in the cytisinicline group (23.4 percent vs 13.2 percent), although the difference was not significant (OR, 2.00, 95 percent CI, 0.82–5.32; p=0.15).

Further analyses showed no evidence cytisinicline was associated with greater odds of cessation compared with placebo in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence, or smoking history.

In terms of safety, cytisinicline was well tolerated. Four participants (3.8 percent) discontinued cytisinicline due to an adverse event.