Varenicline Over-The-Counter Trial on Efficacy and Safety

Abstract

Introduction: Varenicline helps people who smoke quit at rates 2-3 times greater than placebo. Currently, in the United States, varenicline is not available over the counter (OTC).

Aims and methods: In this study, we assessed the safety and efficacy of 1 mg and 0.5 mg 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.

Results: There was no difference in biologically confirmed continuous abstinence by condition between weeks 8 and 12; however, the odds of biologically confirmed point prevalence abstinence were higher for those in the 1 mg 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 1.0 mg b.i.d. condition than the 0.5 mg 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).

Conclusions: The results are suggestive that varenicline is safe and effective as an OTC medication.