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Randomized Controlled Trial
. 2024 Dec 23;27(1):97-105.
doi: 10.1093/ntr/ntae172.

Varenicline Over-The-Counter Trial on Efficacy and Safety

Jennifer Pearson  1 , Mitchell A Nides  2 , Alana Cataldo  3 , Marisol Martinez  2 , Jackie Morales  2 , Ryan Seltzer  3 , Jonathan Kurka  3 , Matthew Broussard  3 , Scott J Leischow  3
Affiliations
Randomized Controlled Trial

Varenicline Over-The-Counter Trial on Efficacy and Safety

Jennifer Pearson et al. Nicotine Tob Res. .

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.

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Conflict of interest statement

SJL received medication for this study at no cost from Pfizer and received funding from Achieve Life Sciences to conduct a clinical trial on cytisinicline (cytisine) for smoking cessation. MAN has received consulting fees from Achieve Life Sciences, a manufacturer of cytisinicline (cytisine) for smoking cessation and has conducted PK/abuse liability studies for manufacturers of nicotine-containing products including Electronic Nicotine Delivery Systems and nicotine pouches. JP is a paid expert witness for the Plaintiffs in a Multi-District Litigation invoking Natural American Spirit Cigarettes and a paid expert witness for the Plaintiffs in a Derivative Litigation invoking Altria Group, Inc. This arrangement has been reviewed and approved by the University of Nevada, Reno in accordance with their conflicts of interest policies. The following coauthors have no declared conflicts: MB, RS, JK, MM, JM, and AC.

Figures

Figure 1.
Figure 1.
CONSORT diagram.
Figure 2.
Figure 2.
Proportion of participants with biologically confirmed continuous smoking abstinence at weeks 4, 8, 12, and 26.
See this image and copyright information in PMC

References

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