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

Shadi Nahvi, Kate S. Segal, Alain H. Litwin, Julia H. Arnsten

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2 Citations (Scopus)

Abstract

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. 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. 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. clinicaltrials.gov NCT01378858.

Original languageEnglish (US)
Pages (from-to)9
Number of pages1
JournalAddiction science & clinical practice
Volume9
DOIs
StatePublished - 2014

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Directly Observed Therapy
Methadone
Randomized Controlled Trials
Smoking Cessation
Opioid Analgesics
Tobacco
Tobacco Use Cessation
Therapeutics
Varenicline
Medication Adherence
Carbon Monoxide
Drug Users
Tuberculosis
Outcome Assessment (Health Care)
HIV

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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title = "Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics.",
abstract = "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. 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. 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. clinicaltrials.gov NCT01378858.",
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AU - Litwin, Alain H.

AU - Arnsten, Julia H.

PY - 2014

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