The National Cancer Institute has awarded Lisa Fucito, PhD, associate professor of psychiatry, a $3.4 million grant to test if varenicline, a medication FDA-approved for smoking cessation, is effective for helping people quit vaping.
Many people who use e-cigarettes want to quit, however there is a critical lack of evidence-based interventions to help people.
Since e-cigarettes contain nicotine, efficacious interventions for smoking cessation should also be effective for vaping cessation, but there have been no large-scale trials. Very little is known about the health effects of e-cigarettes.
To address these gaps, the new trial will enroll 326 adults who report exclusive e-cigarette (i.e., no other tobacco product use) and an interest in quitting. Participants will be randomized to receive either varenicline or a matching placebo for 12 weeks.
Participants in both groups will receive a single counseling session with a health care provider and a self-directed booklet with cessation tips and a link to free text-based support.
Many people who want to quit vaping are likely to get help from their doctor, and the study scientists wanted to replicate that care model. In a smaller pilot trial of this approach, Fucito and colleagues showed a benefit of varenicline.
The new study will also explore potential health changes with cessation including biomarkers of inflammation, oxidative stress, and DNA damage, which are linked to cancer. There are increasing concerns that e-cigarettes may be carcinogenic, but more research is needed.
Fucito, director of the Tobacco Treatment Service at Yale School of Medicine, will conduct the trial in collaboration with co-PI Benjamin Toll, PhD, at the Medical University of South Carolina. Yale will serve as the coordinating site.