# Enhancing the Effectiveness of Varenicline Based Smoking Cessation Treatment

> **NIH NIH R01** · UNIVERSITY OF WISCONSIN-MADISON · 2020 · $1,585,903

## Abstract

PROJECT SUMMARY/ABSTRACT
Cigarette smoking remains the chief preventable cause of cardiovascular and pulmonary
disease. While evidence-based treatments improve a smoker’s chances of quitting successfully,
even with such treatments, the majority of smokers still fail to quit long-term in a given quit
attempt. There is a clear need for more effective treatments. The proposed research would
evaluate two treatment modifications that are designed to enhance the effectiveness of
varenicline, an FDA-approved smoking cessation medication: 1) extending the duration of
varenicline treatment; and 2) adding the nicotine mini-lozenge to varenicline to form a combined
treatment. While existing data suggest that both modifications may substantially enhance
varenicline effectiveness, neither has been adequately tested. The proposed research will use a
2X2 factorial design to randomize 1000 smokers to one of two levels of each of two factors:
Duration (12- vs. 24-weeks of medication) and Adjuvant (varenicline + placebo lozenge vs.
varenicline + nicotine mini-lozenge). Thus, smokers will receive either standard varenicline
treatment (12 weeks of varenicline therapy) or 1 of 3 innovative, enhanced treatments: 12
weeks of varenicline + mini-lozenge, 24 weeks of extended treatment with varenicline only, or
24 weeks of extended treatment with varenicline + mini-lozenge. Analyses will reveal whether
the Duration and Adjuvant modifications produce additive or interactive effects on smoking
abstinence at 52 weeks postquit, the primary outcome. Also, planned comparisons will
determine if any of the enhanced conditions is superior to standard varenicline therapy. The
hypothesis is that 24-week duration and the mini-lozenge adjuvant will produce significant,
additive main effects so that their combination (24-weeks of varenicline + mini-lozenge)
produces higher abstinence rates at 52-weeks postquit than does standard 12-week varenicline
treatment. Other outcomes include prolonged smoking abstinence, treatment cost-effectiveness,
withdrawal suppression, and adverse events. In sum, this research is designed to produce an
especially effective smoking cessation treatment that should increase the rate of pharmacologic
intervention with smokers in healthcare, reduce smoking prevalence in patient populations, and
reduce incidence of cardiovascular and pulmonary disease.

## Key facts

- **NIH application ID:** 9928299
- **Project number:** 5R01HL109031-09
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** Timothy B Baker
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,585,903
- **Award type:** 5
- **Project period:** 2011-08-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9928299

## Citation

> US National Institutes of Health, RePORTER application 9928299, Enhancing the Effectiveness of Varenicline Based Smoking Cessation Treatment (5R01HL109031-09). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9928299. Licensed CC0.

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