Adults who took cytisinicline for six or 12 weeks were three or four times more likely to quit smoking, respectively, at the end of their treatment than those taking placebo, according to clinical trial results published in JAMA Internal Medicine.
The Food and Drug Administration (FDA) has approved various nicotine replacement products, as well as the medications bupropion and varenicline as smoking cessation aids. “However, their long-term smoking cessation rates are modest, adverse effects can limit their use, and many individuals have already tried them without success,” wrote Nancy A. Rigotti, M.D., of Massachusetts General Hospital and Harvard Medical School, and colleagues. “New options are urgently needed because no cessation medication has been approved for use in the US since 2006.”
Cytisinicline is a plant-based alkaloid that binds to nicotine receptors and is used as a smoking cessation aid in several European countries. Drugmaker Achieve Life Sciences conducted the trial in support of their application for approval to the FDA.
Rigotti and colleagues recruited 792 adults who sought to quit smoking, from 20 sites across the United States. Participants took either 3 mg cytisinicline three times a day for 12 weeks; 3 mg cytisinicline three times a day for six weeks followed by placebo for six weeks; or placebo three times a day for 12 weeks. Smoking cessation was biochemically verified (carbon monoxide <10 ppm). All groups received substantial behavioral support and were followed for 24 weeks.
Participants who took cytisinicline for six weeks were 2.9 times more likely to be abstinent from smoking at the end of treatment than those taking only placebo (15% versus 6%, respectively). Similarly, participants taking cytisinicline for 12 weeks were 4.4 times more likely to be abstinent by treatment’s end compared with placebo (30% versus 9%, respectively). The benefits of cytisinicline extended through week 24 in both treatment groups.
The researchers noted that White adults accounted for about 80% of the participants, so the findings may not be generalizable to other racial or ethnic groups. Other study limitations include the exclusion of individuals with suicidal ideation, moderate to severe depression symptoms, and current cannabis or illicit drug use.
“Cytisinicline holds substantial promise, offering efficacy similar to varenicline but a more favorable adverse effect profile,” researchers wrote. “Changes in craving and cotinine biomarkers over time support the proposed mechanism of action of cytisinicline as a partial nicotine agonist. These findings also highlight the potential for cytisinicline to serve as a versatile tool for nicotine cessation, not only for traditional cigarettes but also for other nicotine delivery products.”
For related information, see the Psychiatric News article “Cytisinicline Promising for Vaping Cessation.”
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