Rochester Clinical Research is among five centers in the United States evaluating a nicotine vaping cessation treatment. Sponsored by Achieve Life Sciences, a clinical-stage pharmaceutical company, the trial aims to ultimately fill an unmet need.
E-cigarettes were the most commonly used tobacco product among students last year followed by cigarettes and cigars, according to the 2021 National Youth Tobacco Survey. The findings include use of tobacco products by students in high school (grades 9-12) and middle school (grades 6-8). More than 2 million students were vapers. Overall, some 2.55 million U.S. middle and high school students reported current (past 30 days) use of a tobacco product in 2021, the study states.
Once seen as an alternative to traditional or combustible cigarettes, vaping has become a fast-growing trend. A recent Gallup survey found that 8 percent of Americans report having vaped in the past week, higher than 2021’s 6 percent and at the same rate as in 2019.
Adults younger than 50 (13 percent) are much more likely to report using e-cigarettes than are adults aged 50 and older (1 percent), Gallup notes. Men and women are equally likely to report using e-cigarettes.
Matthew Davis M.D., a family medicine practitioner and medical director at RCR, notes that while vaping might be better than inhaling chemicals associated with burning tobacco leaves, it is not entirely safe. Additionally, it is not heavily regulated. There is no oversight on the concentration of nicotine levels in vaping pods or on the additives contained in them, he says.
Cigarette smoking is responsible for more than 480,000 deaths per year in the U.S., including more than 41,000 deaths resulting from secondhand smoke exposure, according to the Centers for Disease Control. In 2018, cigarette smoking cost the U.S. more than $600 billion, including more than $240 billion in health care spending, the agency estimates.
Washington-based Achieve Lifesciences’ ORCA-V1, a Phase II study being conducted at RCR, hopes to provide a solution for those who want to quit vaping. The trial is examining the effectiveness and tolerability of cytisinicline, a plant-based alkaloid.
“It’s a naturally derived plant compound from the seeds of a tree. It was first used in Eastern Europe, probably for some time, hundreds of years. By chewing these seeds, people realized they’d lessened their need, a desire for smoking cigarettes,” says Davis, a member of the investigation team at RCR.
Cytisinicline is believed to aid in smoking and e-cigarette cessation by binding to nicotine receptors in the brain. Its molecular structure shares similarity with nicotine and has been known to provide users with a satisfaction akin to a cigarette, reducing acute withdrawal symptoms.
Cytisinicline is often referred to as the “poor man’s Chantix or natural Chantix,” Davis says. Pfizer’s Chantix is a popular smoking cessation treatment. Achieve is hoping to get Food and Drug Administration approval for cytisinicline use in the U.S. as a method for those who want to quit both vaping and smoking.
Ideal candidates for the ORCA V-1 trial are current vapers and not smokers. They are required to set a quit date within a week or two weeks of starting treatment and are assessed on their abstinence—self-reported and verified by biochemical testing at each weekly assessment. They also need to be willing to actively participate in the study’s vaping cessation behavioral support provided throughout the study.
Subjects are on the medicine for 12 weeks, Davis says.
“Hopefully, in that time, you can become abstinent from vaping nicotine. They’re just looking to see how many people this will help in terms of quitting nicotine,” he says. “In the smoking trials, it was quite effective. It seems to be that you’re six to eight times more likely to quit smoking combustion cigarettes if you use this medicine, than if you didn’t.”
The vaping cessation trial is likely to continue into 2023, once sites have enrolled a total of 150 subjects. RCR is actively seeking candidates to participate in the study.
“It is a bit of a scourge,” Davis says of vaping. “Having a medicine like this available will help people who are ready to quit using nicotine.”
Those interested in joining the study at RCR find more details here.