Varenicline Over-The-Counter Trial on Efficacy and Safety

Area of Science:

• Pharmacology
• Public Health
• Clinical Trials

Background:

• Varenicline is a prescription medication proven effective for smoking cessation, approximately doubling quit rates compared to placebo.
• Currently, varenicline is not available over-the-counter (OTC) in the United States, limiting accessibility for individuals seeking to quit smoking.

Purpose of the Study:

• To assess the safety and efficacy of over-the-counter (OTC) varenicline at 1 mg and 0.5 mg dosages for smoking cessation.
• To compare the effectiveness of OTC varenicline against a placebo in a randomized, double-blind, placebo-controlled study.

Main Methods:

• A randomized, double-blind, placebo-controlled study involving 313 participants across two US clinical sites.
• Participants received 1 mg varenicline, 0.5 mg varenicline, or placebo for 12 weeks.
• Smoking cessation was biologically confirmed using breath carbon monoxide and urine cotinine levels, with remote participation accommodated during the COVID-19 pandemic.

Main Results:

• No significant difference in continuous abstinence rates between groups from week 8 to week 12.
• 1 mg varenicline significantly increased the odds of point prevalence abstinence at week 12 compared to placebo (OR 3.39) and 0.5 mg varenicline (OR 2.37).
• Adverse events were generally mild and consistent with known side effects, including vivid dreams and nausea.

Conclusions:

• Varenicline at a 1 mg dosage appears to be safe and effective for smoking cessation when available as an over-the-counter (OTC) medication.
• The findings suggest that OTC varenicline could be a viable option to increase accessibility for individuals attempting to quit smoking.