# Achieving smoking cessation milestones in opioid treatment patients: a randomized 2 x 2 factorial trial of directly observed and long-term varenicline

> **NIH NIH R01** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2020 · $680,578

## Abstract

ABSTRACT
 Tobacco use and tobacco-related disease are highly prevalent among persons with opioid use disorders
(OUD). Unfortunately, traditional evidence-based smoking cessation interventions have yielded low rates of
tobacco abstinence in this group. The majority of trials evaluating smoking cessation treatment interventions
among persons with OUD have relied on short-term interventions that do not account for the unique challenges
faced by these smokers, specifically, establishing initial abstinence, adhering to evidence-based cessation
treatments, and maintaining abstinence once active treatments cease. Long-term smoking cessation
medication treatment approaches have shown promise in promoting cessation and decreasing relapse among
individuals without OUD, however the applicability of extended medication approaches to smokers with OUD
may be limited by poor adherence to smoking cessation medications. Though adherence to cessation
medication is strongly associated with cessation success, adherence is especially challenging for persons with
OUD. Opioid treatment program-based directly observed therapy (DOT) interventions improve clinical
outcomes in HIV and TB, and our pilot data suggest that DOT varenicline is associated with increased smoking
cessation medication adherence and may increase smoking cessation rates. We therefore propose a 2 x 2
factorial, randomized, double-blind, placebo-controlled trial to efficiently test two interventions: directly
observed medication therapy, and long-term therapy with varenicline. Our analytic strategy will evaluate the
milestones in smoking cessation—achieving initial abstinence, preventing lapse and preventing relapse--
necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and
pharmacogenetic factors that influence these cessation processes. We will recruit 450 smokers with OUD from
community-based, outpatient opioid treatment programs and test the following specific aims: (1) to test the
efficacy of directly observed varenicline therapy compared to self-administered varenicline therapy on smoking
cessation milestones, (2) to test the efficacy of long-term varenicline compared to short-term varenicline on
smoking cessation milestones, and (3) to understand the mechanism of smoking cessation by examining the
impact of theory-guided psychological and social factors and of pharmacogenetic factors on cessation
milestones. This proposal is innovative, and addresses the challenges of both promoting and maintaining
tobacco abstinence among smokers with OUD.

## Key facts

- **NIH application ID:** 9634050
- **Project number:** 5R01DA042813-04
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** Shadi Nahvi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $680,578
- **Award type:** 5
- **Project period:** 2017-04-01 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9634050

## Citation

> US National Institutes of Health, RePORTER application 9634050, Achieving smoking cessation milestones in opioid treatment patients: a randomized 2 x 2 factorial trial of directly observed and long-term varenicline (5R01DA042813-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9634050. Licensed CC0.

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