Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction, and End-of-Treatment Quit Rates.

Abstract

The majority of attempts to stop smoking end in failure. One way to improve success may be to explore different combinations of existing cessation medications. This observational study examined "triple therapy" (varenicline + nicotine patch + nicotine lozenge) in 36 smokers trying to quit. A 12-week, observational study exploring tolerability, via adverse events (AEs) elicited at each of 9 phone assessments. Secondary outcomes included satisfaction rates, medication changes, and self-reported quit rates at week 12. 35 of 36 participants reported at least one AE. Insomnia (75%), abnormal dreams (72%) and nausea (64%) were most common. Most were mild to moderate. No deaths, hospitalizations, cardiovascular events, or suicidality were reported. Six participants (17%) decreased the dose of at least one medication, 5 (14%) decreased the dose then discontinued at least one medication, and 13 (36%) discontinued at least one medication without trying a lesser dose. Participants were highly satisfied with their medications, and 58% reported quitting at 12 weeks, with 38% reporting prolonged abstinence. Despite high rates of AEs and medication changes, high rates of satisfaction and self-reported quitting, with no serious AEs, were observed with triple therapy. Additional data on tolerability and efficacy are needed. clinicaltrials.gov number NCT02681510.