Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape

PROJECT SUMMARY Over the past decade, dual use of combustible cigarettes and electronic cigarettes (e-cigarettes) has risen substantially. The evidence is mixed as to whether this use pattern helps dual users quit using combustible cigarettes. However, there is a clear need to help dual users quit smoking, given that use of combustible cigarettes is the leading preventable cause of death and disease in the US, causing one-third of all cancer deaths and exacting an enormous financial and personal toll. To date, no published studies have identified effective pharmacotherapy or counseling interventions to help dual users quit smoking. The goal of the proposed research is to identify the most effective pharmacotherapy and counseling approaches to help dual users quit smoking. Specifically, using the Multiphase Optimization Strategy (MOST), dual users of combustible cigarettes and e-cigarettes (N=500) who are motivated to quit smoking and willing to quit their e- cigarette use, if asked, will be enrolled in a randomized efficient 2x2x2 factorial clinical trial. Participants will be randomized to one of two levels of each factor: Pharmacotherapy (Varenicline vs. Nicotine Patch), Counseling Approach (a Dual Focused Cessation approach in which participants are encouraged to quit their e-cigarette use as part of their quit attempt vs. a Smoking Focused Cessation approach in which participants are encouraged to quit smoking and to use their e-cigarettes strategically to replace their cigarettes in service of harm reduction), and Counseling Intensity (4 vs. 1 session). All participants will complete baseline measures of demographics, tobacco use history, combustible and e-cigarette dependence, and potential mechanisms. Participants will use smartphones to complete ecological momentary assessments (EMA) for 2 weeks pre- target quit date (TQD) and 2 weeks post-TQD; participants will record smoking, vaping, and medication use in real-time and complete EMAs of potential mechanisms (e.g., craving reduction, self-efficacy) every evening. Follow-up assessments of combustible and e-cigarette use, as well as potential mechanisms, will occur 4, 8, 12, 18, 26, 39, and 52 weeks post-TQD. Participants will also complete biochemical assays of combustible tobacco use (carbon monoxide [CO]) and nicotine exposure (urine cotinine) at baseline, one-week pre-TQD, and 3 months post-TQD. Participants who report 7-day point-prevalence abstinence from smoking at Weeks 26 or 52 will be invited to the laboratory to provide biochemical verification of abstinence (CO<6 ppm) and provide a urine sample to assay nicotine exposure (cotinine). These data will allow us to identify the best medication approach as well as the best counseling approach and intensity to help dual users quit smoking.