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

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


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

Original languageEnglish (US)
Article number9
JournalAddiction Science and Clinical Practice
Issue number1
StatePublished - Jan 27 2014
Externally publishedYes


  • Adherence
  • DOT
  • Directly observed therapy
  • Methadone
  • Opioid-related disorders
  • Smoking cessation
  • Varenicline

ASJC Scopus subject areas

  • Medicine(all)


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