“Natural” help may be on the horizon for the 11m American adults who use e-cigarettes to vape nicotine, at least half of whom want to quit but are battling to do so because of nicotine’s addictive nature.
A plant-based medication called cytisinicline may be an effective therapy to help them give up vaping, suggest the results of a clinical trial co-led by an investigator from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system.
In the double-blind randomised clinical trial, 160 adults who vaped nicotine but did not smoke cigarettes were assigned to take either oral cytisinicline or placebo tablets for 12 weeks. All had weekly behavioural 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 nine to 12 (31.8% vs. 15.1%, p=.04). MedicalXPress reports that the drug was well tolerated, with comparable rates of side effects between the groups.
Cytisinicline is a plant alkaloid derived from the seeds of the Laburnum tree.
The study was conducted at Massachusetts General Hospital and four other sites.
“No medication has been approved by the FDA for vaping cessation in the US,” said lead author Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Centre and a professor of medicine at Harvard Medical School.
“However, our study indicates that cytisinicline might be an option to fill this gap and help adult vapers to quit.”
The findings were published in JAMA Internal Medicine.
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 hypothesised 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.”
Study details
Cytisinicline for vaping cessation in adults using nicotine e-cigarettes: The ORCA-V1 randomised clinical trial
Nancy Rigotti, Neal Benowitz, Judith Prochaska, et al
Published in JAMA Internal Medicine on 6 May 2024
Abstract
Importance
The prevalence of e-cigarette use among US adults, especially young adults, is rising. Many would like to quit vaping nicotine but are unable to do so. Cytisinicline, a plant-based alkaloid, targets nicotinic acetylcholine receptors, reduces nicotine dependence, and helps adults to stop smoking cigarettes. Cytisinicline may also help e-cigarette users to quit vaping.
Objective
To determine the efficacy and safety of cytisinicline vs placebo to produce abstinence from e-cigarette use in adults seeking to quit vaping nicotine.
Design, Setting, and Participants
This double-blind placebo-controlled randomised clinical trial compared 12 weeks of treatment with cytisinicline vs placebo, with follow-up to 16 weeks. It was conducted from July 2022 to February 2023 across 5 US clinical trial sites. A total of 160 adults who vaped nicotine daily, sought to quit, and did not currently smoke cigarettes were enrolled, and 131 (81.9%) completed the trial.
Intervention
Participants were randomised (2:1) to cytisinicline, 3 mg, taken 3 times daily (n = 107) or placebo (n = 53) for 12 weeks. All participants received weekly behavioural support.
Main Outcomes and Measures
Biochemically verified continuous e-cigarette abstinence during the last 4 weeks of treatment (weeks 9-12; primary outcome) and through 4 weeks’ post-treatment (weeks 9-16; secondary outcome). Missing outcomes were counted as non-abstinence.
Results
Of 160 randomised participants (mean [SD] age, 33.6 [11.1] years; 83 [51.9%] female), 115 (71.9%) formerly smoked (≥100 lifetime cigarettes). Continuous e-cigarette abstinence in cytisinicline and placebo groups occurred in 34 of 107 participants (31.8%) vs 8 of 53 participants (15.1%) (odds ratio, 2.64; 95% CI, 1.06-7.10; P = .04) at end of treatment (weeks 9-12) and in 25 of 107 participants (23.4%) vs 7 of 53 participants (13.2%) during weeks 9 to 16 (odds ratio, 2.00; 95% CI, 0.82-5.32; P = .15). There was no evidence, based on non-significant interactions, that cytisinicline efficacy differed in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence, or smoking history. Cytisinicline was well tolerated, with four participants (3.8%) discontinuing cytisinicline due to an adverse event.
Conclusions and Relevance
In this randomised clinical trial, cytisinicline for 12 weeks, with behavioural support, demonstrated efficacy for cessation of e-cigarette use at end of treatment and was well tolerated by adults, offering a potential pharmacotherapy option for treating nicotine e-cigarette use in adults who seek to quit vaping. These results need confirmation in a larger trial with longer follow-up.
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