Varenicline plus minimal behavioral support aids in e-cigarette cessation

Key takeaways:

• Minimal behavioral support included a self-guided cessation booklet and a counseling session.
• More adults receiving varenicline vs. placebo reported adverse events, but none were serious.

More adults with exclusive daily e-cigarette use receiving 8-week varenicline quit than those receiving placebo, according to a research letter published in American Journal of Preventive Medicine.

“Our findings provide support for the safety and efficacy of varenicline for helping people quit e-cigarettes with minimal behavioral support, including among those with current mental health concerns like depression,” Lisa M. Fucito, PhD, director of the tobacco treatment service at Yale Cancer Center and associate professor of psychiatry at Yale University School of Medicine, told Healio.

“With brief advice from their clinician about setting a quit date and how to use the medication, many people will be able to quit e-cigarettes with medication alone like varenicline,” she continued. “Thus, patients should be asked about potential e-cigarette use across health settings and offered this treatment.”

In a randomized, double-blind, placebo-controlled preliminary clinical trial, Fucito and colleagues assessed 40 adults (mean age, 28.2 years; 50% men; 80% white) who only used e-cigarettes daily for at least 6 months to determine if varenicline for 8 weeks is better than placebo based on self-reported 7-day point prevalence e-cigarette abstinence.

This outcome was also assessed 4 weeks after the end of the treatment period.

In addition to exclusive e-cigarette use, included adults had to have no other past 30-day tobacco use, according to researchers.

Every adult in this study participated in one counseling session and had a self-guided cessation booklet along with their randomized treatment.

Notably, 10 individuals in this population had anxiety, and nine had depression.

Of the total cohort, 18 adults receiving varenicline and 17 adults receiving placebo had 8-week data, and more individuals in the varenicline group stopped using e-cigarettes at this point (n = 9 vs. n = 6; RR = 1.51; 95% CI, 0.68-3.37).

For the follow-up visit at week 12, researchers observed nearly identical quit rates as those above, with eight adults in the varenicline group and six adults in the placebo group (RR = 1.36; 95% CI, 0.59-3.13).

In an additional assessment, the total population was divided based on the presence of smoking history (n = 21 with; n = 19 without), which revealed that quitting e-cigarettes occurred more frequently in the group of adults with vs. without a smoking history (n = 10 vs. n = 5).

“Recent findings from epidemiologic research using national survey data suggested that adults without a cigarette smoking history may have greater e-cigarette quit intentions and/or likelihood of making a quit attempt or cutting back in the past year,” Fucito said. “Yet, participants in our trial without a former cigarette smoking history may have been more dependent on e-cigarettes, and individuals with greater nicotine dependence tend to have more difficulty quitting.”

The study also highlighted that before study entry, all but one adult without a smoking history (94.7%) reported near constant vaping, whereas 15 out of 21 adults (71.4%) with a smoking history reported this behavior.

"[To identify near constant vaping,] we asked participants using a single item whether they vape continuously throughout the day or not and they had to respond by selecting yes or no,” Fucito said.

Based on entries from weekly electronic diaries, more individuals receiving varenicline vs. placebo reported adverse events (n = 12 vs. n = 5).

Sixty adverse events — none identified as serious — occurred within the total cohort. Researchers noted that common reports of nausea, insomnia and vivid dreams/nightmares are “typical of varenicline.”

In the varenicline group, researchers deemed eight adverse events possibly related to the treatment, whereas this was only the case for one event in the placebo group.

Fucito told Healio future studies on varenicline should assess outcomes after a 12-week treatment period and look into potential modifying response factors.

“Future research needs to evaluate factors that may modify treatment response such as demographic characteristics and clinical characteristics like cigarette smoking history and vaping behaviors, for optimal treatment tailoring and targeting,” she said.

“If these factors are important, behavioral interventions need to be developed and tested as adjunctive therapies to improve quitting outcomes with varenicline and/or other medications,” Fucito added.

Additional items that could be investigated in the future according to Fucito include a longer treatment period, higher varenicline dose (up to 3 mg) and add-on pharmacotherapies.

“This is a new field,” Fucito said. “We have only begun to explore how to help people quit e-cigarettes and remain abstinent. A range of treatment options will be needed to help people.”

Reference:

• First U.S. trial of varenicline for e-cigarette cessation shows positive results. https://medicine.yale.edu/news-article/first-us-trial-of-varenicline-for-e-cigarette-cessation-shows-positive-results/. Published May 16, 2024. Accessed May 28, 2024.