Varenicline OTC Trial on Efficacy and Safety.

Abstract

Varenicline helps people who smoke quit at rates 2-3 times greater than placebo. Currently in the U.S., varenicline is not available over the counter (OTC). In this study, we assessed the safety and efficacy of 1mg and 0.5mg varenicline as an OTC medication for smoking cessation in comparison to placebo. This randomized, double-blind, placebo-controlled study was performed at two clinical sites in the United States of n=313 people. The treatment period was 12 weeks. During the COVID pandemic, the protocol was modified to allow remote participation; verification of smoking status was via breath carbon monoxide levels for in-person visits and mailed urine cotinine kits for the remote participants. There was no difference in biologically confirmed continuous abstinence by condition between Weeks 8-12; however, the odds of biologically confirmed point prevalence abstinence were higher for those in the 1mg b.i.d. condition than for those in the placebo condition at Week 12 (OR 3.39; 95% CI 1.49, 7.71), and were higher for those assigned to the 1.0mg b.i.d. condition than the 0.5mg b.i.d. condition at Week 12 (OR 2.37; 95% CI 1.11, 5.05). Adverse events were modest, and as expected (vivid dreams and nausea in the medication conditions). The results are suggestive that varenicline is safe and effective as an OTC medication.