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Open Access Study Protocol

Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics

Shadi Nahvi12*, Kate S Segal1, Alain H Litwin12 and Julia H Arnsten123

Author Affiliations

1 Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, 10467 Bronx, NY, USA

2 Department of Psychiatry & Behavioral Sciences, Albert Einstein College of Medicine, 111 East 210th Street, 10467 Bronx, NY, USA

3 Department of Epidemiology & Population Health, Albert Einstein College of Medicine, 10467 Bronx, NY, USA

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Addiction Science & Clinical Practice 2014, 9:9  doi:10.1186/1940-0640-9-9

Published: 13 June 2014

Abstract

Background

Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment.

Methods/Design

We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models.

Discussion

This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment.

Trial Registration

clinicaltrials.gov NCT01378858

Keywords:
Adherence; Smoking cessation; Varenicline; Directly observed therapy; DOT; Methadone; Opioid-related disorders