# Comparative Effectiveness of Sequential Pharmacotherapeutic Strategies and Virtually Delivered Treatment to Optimize Smoking Cessation

> **NIH NIH R01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2024 · $923,199

## Abstract

PROJECT SUMMARY
 There is a critical need for treatment approaches that conveniently deliver evidence-based interventions of
counseling and pharmacotherapy to a wide range of smokers, and address the complex timeline of cessation
attempt, failure, and re-attempt. The objective of this proposal is to identify the best individualized
pharmacological treatment strategies used for both initial smoking cessation and for rescue therapy among
those who fail to quit or relapse. The trial will use a SMART design (Sequential Multiple Assignment
Randomized Trial) to estimate the comparative effectiveness of (1) an initial 6-week course of either standard
dose varenicline or dual nicotine replacement (our two best performing pharmacotherapies), and (2) among
those smokers who initially fail to quit after the first 6 weeks, to estimate the effects of either continuing on
same medication for another 6 weeks, switching to the medication they did not receive initially, or augmenting
current pharmacotherapy by increasing the dose or adding additional FDA-approved cessation medications. All
treatments will occur via a virtual delivery method ensuring the widest possible application with the fewest
barriers and will include both dynamic pharmacotherapy and counseling delivered in a unified environment to
enhance uptake, effectiveness, and patient experience. The proposed trial will include 2000 adult participants
from throughout Texas who are seeking to quit smoking. Participants will be initially randomly assigned to one
of our two best-performing smoking cessation treatments, either dual nicotine replacement therapy (NRT;
nicotine patch plus lozenge) or varenicline (2 mg/twice daily). After 6 weeks, smoking abstainers will remain on
their current treatment and non-abstainers will be re-randomized to either (a) switch therapies (i.e., receive the
treatment not given in the first 6 weeks), (b) augment their current therapy (change dosage and/or add other
medications, e.g., bupropion), or (c) continue the same medication for 6 more weeks. The treatments will
function as comparators with each other at the selected timepoints specific to each treatment phase. Our
primary outcomes will be biochemically verified (carbon monoxide <6 ppm) continuous smoking abstinence at
Week 6 and at end-of-treatment (EOT) + 30 days. Our secondary outcomes include 6-month abstinence, and
withdrawal, craving, positive and negative affect, and depressive symptoms (anhedonia) Week 6 and at end-
of-treatment (EOT) + 30 days. Our results will inform the patient-provider discussion on the optimal treatment
approach of the future dissemination of our findings. This addresses a critical gap in treating nicotine
dependence because while the majority of smokers relapse within two weeks of an initial cessation attempt
there is little empirical evidence to guide clinicians or patients on the best subsequent treatment to enhance the
likelihood of cessation. Our study sample will be representative of ...

## Key facts

- **NIH application ID:** 10797577
- **Project number:** 1R01CA278938-01A1
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** PAUL MICHAEL CINCIRIPINI
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $923,199
- **Award type:** 1
- **Project period:** 2024-01-01 → 2028-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10797577

## Citation

> US National Institutes of Health, RePORTER application 10797577, Comparative Effectiveness of Sequential Pharmacotherapeutic Strategies and Virtually Delivered Treatment to Optimize Smoking Cessation (1R01CA278938-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10797577. Licensed CC0.

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