# Varenicline OTC Trial on Efficacy and Safety

> **NIH NIH R01** · ARIZONA STATE UNIVERSITY-TEMPE CAMPUS · 2020 · $490,192

## Abstract

Abstract
 Seven medications have been approved for the treatment of tobacco addiction in
the United States, five that are nicotine replacement and two are non-nicotine. Three of
the NRT products (i.e. patch, gum, lozenge) are available as over-the-counter (OTC)
products because clinical trials have shown that they are safe and effective without
healthcare provider involvement.
 After multiple studies, including one of the largest smoking cessation trials
(`EAGLES' study) ever conducted, the evidence is clear that varenicline has the greatest
probability of helping the most smokers quit and results in adverse events that are no
worse than current OTC NRT products.
 Given these data, the time has come to explore whether varenicline is safe and
effective as an OTC medication. In addition, because earlier research found that .5mg
twice a day (b.i.d.) varenicline is as effective as the currently FDA-approved 1.0mg b.i.d
but with lower incidence of nausea and sleep disturbance, there is value in assessing
whether the lower dose will work as well as the higher dose in an OTC environment.
Thus, the primary goal of the proposed research is to test whether varenicline is a solid
candidate for switching from prescription (Rx) to OTC, and whether a dose lower than
that currently approved is as effective in an OTC environment. To understand the within-
person mechanisms explaining how and when OTC varenicline might improve cessation
outcomes, we also propose to assess experience with OTC varenicline via (a) ecological
momentary assessment (EMA) and (b) interviews in a subset of participants.

## Key facts

- **NIH application ID:** 9965877
- **Project number:** 5R01DA044125-04
- **Recipient organization:** ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
- **Principal Investigator:** SCOTT J LEISCHOW
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $490,192
- **Award type:** 5
- **Project period:** 2017-09-30 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9965877

## Citation

> US National Institutes of Health, RePORTER application 9965877, Varenicline OTC Trial on Efficacy and Safety (5R01DA044125-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9965877. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*