Varenicline is the single most effective medication for smoking cessation. At present, it is available only by prescription, but recent studies suggest that the risks of using this medication are comparable to nicotine replacement. The current study is designed to assess the safety and efficacy of varenicline as an OTC medication, which if eventually approved for use in that way would make this medication more accessible to more smokers - particularly populations least likely to access clinical care. August 1, 2023