Plant-based drug can help people quit vaping, study shows 

Vaping smoking cessation

A plant-based medication called cytisinicline may be an effective therapy to people stop vaping, according to the ORCA-V1 trial results in the Journal of the American Medical Association (JAMA) Internal Medicine.  

Cytisinicline, also known as cytisine, baptitoxine, or sophorine, is an alkaloid that occurs naturally in several plant genera and has been used medically in relation to smoking cessation.

The ORCA-V1 trial was led by Achieve Life Sciences, and co-led by an investigator from Massachusetts General Hospital. It evaluated the efficacy and safety of 3mg cytisinicline dosed three times daily for 12 weeks compared to placebo in 160 non-smoking adults who used e-cigarettes or nicotine vapes and wanted to quit e-cigarettes. All participants received behavioural support for vaping cessation.

“No medication has been approved by the FDA for vaping cessation in the United States,” said lead author Nancy Rigotti, 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 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.” 

Trial results and observations 

The ORCA-V1 trial demonstrated that biochemically confirmed continuous vaping abstinence during the last four weeks of treatment, the primary outcome measure, was significantly higher for cytisinicline treatment compared to placebo. For cytisinicline treatment compared to placebo, 31.8% versus 15.1% of participants were abstinent during weeks 9 to 12, and participants receiving cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping (odds ratio (OR) 2.64 [95% CI, 1.06-7.10]; P=.04) 

A consistent trend in favour of cytisinicline was found across the secondary endpoints, evaluating abstinence during and beyond end of treatment. During the 12-week study treatment, the past seven-day prevalence of vaping abstinence at each week was consistently higher in the cytisinicline group than the placebo group. Similarly, the mean biochemical cotinine levels were consistently lower in the cytisinicline group than the placebo group at each weekly visit during study treatment. Including a four-week follow-up after treatment ended, continuous abstinence from weeks 9 to 16 remained higher in the cytisinicline group than the placebo group at 23.4% versus 13.2%, respectively (OR, 2.0; [95% CI, 0.82-5.32]). 

Study drug compliance was high; 72.7% and 66.0% of participants treated with cytisinicline and placebo, respectively, took >90% of study drug doses. Cytisinicline was well tolerated and no serious adverse events were reported. Similar rates of adverse events were observed between treatment arms (50.9% in the cytisinicline arm versus 54.7% in the placebo arm). The most frequent (>5%) treatment-emergent adverse events for cytisinicline subjects were sleep disturbances, anxiety, headache, fatigue, and upper respiratory tract infection and for placebo subjects were nausea, Covid-19, headache, anxiety and upper respiratory tract infection. Higher rates of headache and nausea were reported by participants treated with placebo. 

“As we’ve seen now in multiple clinical trials, the safety and tolerability profile of cytisinicline is very compelling and we believe it will be a key driver of compliance when approved for use,” commented Cindy Jacobs, President and Chief Medical Officer at Achieve. “Many people who attempt to quit nicotine struggle with withdrawal symptoms and cravings, making it difficult to maintain abstinence. Current treatments can have high rates of headaches and nausea, and we are simply not seeing that with cytisinicline, giving us confidence that cytisinicline’s profile will help more people, who want to quit, succeed in doing so.” 

Prevalence of e-cigarettes in the US 

As many as 11 million US 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.

It is estimated that 4.5% among all adults in the US and 11% among adults aged 18-24 used e-cigarettes in 2021. While adults who switch from smoking combustible cigarettes to using nicotine e-cigarettes reduce their tobacco-related health risks, e-cigarettes products are not harmless and sustain nicotine dependence.  In surveys, more than half of adults who vape nicotine plan to quit. 

Cytisinicline, if approved, could be the first prescription drug to help people who are ready to address their addiction to e-cigarettes. Achieve plans to conduct an End-of-Phase II Meeting with the FDA later this year to discuss future clinical trial requirements to pursue an indication for vaping cessation.

Megan Thomas, Multimedia Editor, DDW

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