For years, e-cigarettes have been marketed as a safer alternative to smoking. While e-cigarettes are less toxic than traditional cigarettes, the reality is more complicated, particularly for people who have never smoked and for youth.
Vaping products are highly addictive, widely used and hard to quit. They also pose health risks, including potential damage to the lungs and cardiovascular system, and emerging evidence of their potential to lead to cancer.
Despite the growing number of users who want to stop vaping, there are currently no Food and Drug Administration (FDA)-approved treatments designed specifically to help them. Researchers at MUSC Hollings Cancer Center are hoping to change that.
Benjamin Toll, Ph.D., director of the Tobacco Treatment Program at MUSC Health and co-director of the Lung Cancer Screening Program at Hollings, is working with Lisa Fucito, Ph.D., director of the Tobacco Treatment Service at Smilow Cancer Hospital at Yale New Haven Health, on a new study to test whether a well-known medication for smoking cessation could also help people to quit vaping.
Called varenicline, the medication is probably better known by its former brand name, Chantix. This study, funded by the National Institute of Health's National Cancer Institute, will help identify effective strategies for e-cigarette cessation and the health benefits of quitting.
"We see more than 10,000 patients a year," Toll said. "Many of them tell us they want to quit vaping. The problem is we have nothing FDA-approved to offer them. That's why this study is so important."
Although smoking rates in the U.S. are falling, the rise of vaping and nicotine products like oral pouches and related products like cannabis is changing the landscape of addiction. This is especially true for young people, who describe the new products as far more appealing than traditional cigarettes.
"We want to give people who are struggling with vaping a path forward. We know they want to quit. It's time we catch up with the tools to help them."Benjamin Toll, Ph.D.
What's more, the convenience and design of vaping products – some offering tens of thousands of puffs – make them harder to put down than cigarettes.
"There's no natural stopping point," Toll said. "People can vape in bed, put it under their pillow and then wake up in the middle of the night and take a puff. That kind of constant access changes the addiction dynamic."
Varenicline has been used for years to help cigarette smokers quit by reducing cravings and withdrawal symptoms. Now that the drug is made by multiple manufacturers and is more affordable, Toll and his colleagues want to see if it works as well for people who vape.
Toll and Fucito have already conducted a small pilot study that showed promising results. In that randomized study, significantly more participants who received varenicline successfully quit vaping by the end of treatment, compared with the placebo group, and continued to abstain at three-month follow-up. That is similar to the success rates seen when varenicline was first approved for smokers in 2006.
This new larger study will include 326 participants across two research sites at Hollings and Yale. All participants must be at least 18 years old and exclusive e-cigarette users. They can have smoked cigarettes in the past but not within the last 30 days.
Participants will be randomly assigned to receive 12 weeks of either varenicline or a placebo. Not only will participants receive the medication but also brief counseling on quitting and self-management resources. The counseling sessions will be less than five minutes so that primary care doctors could easily use this approach in their own offices.
Participants will log their progress using daily digital diaries and upload short videos showing themselves taking the medication. This not only tracks adherence but ensures the researchers are seeing a real effect from the drug.
Quit rates will be assessed at the end of treatment and up to six months later. The researchers will also collect saliva and blood samples to verify that participants quit vaping and to assess potential health benefits of doing so, such as changes in biological markers linked to cancer.
Ultimately, the goal is to gather enough evidence to seek FDA approval for varenicline as a vaping cessation treatment. If successful, it would be the first medication approved specifically for helping e-cigarette users to quit.
"We want to give people who are struggling with vaping a path forward," Toll stressed. "We know they want to quit. It's time we catch up with the tools to help them."
