SC Connecticut News

The first U.S. trial of varenicline for e-cigarette cessation shows promising results and warrants larger-scale trials, researchers say.

On May 16, in the American Journal of Preventive Medicine, researchers from Yale Cancer Center and the Hollings Cancer Center at the Medical University of South Carolina (MUSC) published the results of their clinical trial of varenicline to help adults stop using e-cigarettes.

The results showed a significant disparity between the placebo group and the group receiving the medication. “We had a 15% difference in quit rates, with those in the medication group having a quit rate of 45 percent,” said Lisa Fucito, PhD, lead author and director of the Tobacco Treatment Service at Yale Cancer Center and Smilow Cancer Hospital. Fucito is an associate professor of psychiatry at Yale School of Medicine.

Benjamin Toll, PhD, director of the Tobacco Treatment Program at MUSC Health, adjunct professor of psychiatry at Yale School of Medicine, and senior author on the study, said the researchers designed the trial to mimic real-world conditions as much as possible – from the people who enrolled in the trial to the type of support they would likely receive from primary care providers.

The publication follows closely on a trial of cytisinicline for e-cigarette cessation. The two drugs work similarly; however, varenicline is already available in generic versions while cytisinicline has not yet received FDA approval.

Varenicline, known by its brand name Chantix, is FDA-approved to help adults stop smoking traditional cigarettes. Despite growing numbers using e-cigarettes, there are no approved medications to help them quit.

“People can get to very high levels of nicotine exposure with these e-cigarette products, and they can use them near constantly throughout the day. So, the question we all have is, ‘Can any pharmacotherapy stand up to this challenge?’” Fucito said.

People who smoke cigarettes have natural stopping points when finishing a cigarette or running out. E-cigarettes can last for over 5,000 puffs making them harder to track but easier to use continuously. Toll noted patients often keep their e-cigarettes under their pillows for immediate access upon waking.

Previous studies indicate most e-cigarette users want to quit but it’s unclear if products used for traditional cigarettes would work for e-cigarettes.

“We need more pharmacotherapy treatments to help address the really strong physical dependence that can develop from e-cigarette use," Fucito said. "People undergo significant withdrawal when they try to stop."

A recent Italian study combined pharmacotherapy with intense weekly behavioral counseling sessions; similarly, a cytisinicline trial included weekly 10-minute sessions with trained counselors.

In this study, researchers wanted to see how well pharmacotherapy could work under typical health care conditions without follow-up counseling sessions. They developed a self-guided cessation booklet with practical tools and tips for quitting. A licensed health care provider met each patient briefly for advice and instructions on setting a quit date one or two weeks after starting medication.

“We took a much lighter touch to reflect the behavioral support that you’d likely experience if you went to your doctor and asked for help with quitting e-cigarettes,” Fucito said.

The study also included some patients with histories of depression. This was significant because Chantix once had a “black box warning” due to reports linking it to psychiatric side effects. That warning was dropped in 2016 after a large study showed it safe; however, stigma remains among healthcare providers and patients.

“There’s still some hesitancy to prescribe this very safe – now generic – drug, and it really shouldn't be that way,” Toll said.

None of this study's participants experienced serious side effects; most reported nausea, insomnia or vivid dreams. Importantly, those who stopped vaping didn’t revert back to cigarettes.

“If you have a former smoking history...you’re going to go back to smoking when you quit vaping,” Toll said. “And we did not find that.”

However, one challenge uncovered indicated that people without cigarette smoking history might find it harder to quit e-cigarettes due possibly higher continuous nicotine intake throughout the day.

Larger trials are needed but this trial should give healthcare providers confidence in prescribing varenicline for patients trying to stop using e-cigarettes.

“We want people to come back to this medication,” Fucito said. “There are people who need help now...because technology facilitates nicotine use on a level that we’ve never seen before.”