title: Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov NCT01378858.
authors.affiliation: Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, 10467 Bronx, NY, USA. snahvi@montefiore.org.
authors.forename: Shadi
authors.initials: S
authors.lastname: Nahvi
authors.forename: Kate S
authors.initials: KS
authors.lastname: Segal
authors.forename: Alain H
authors.initials: AH
authors.lastname: Litwin
authors.forename: Julia H
authors.initials: JH
authors.lastname: Arnsten
mesh_terms: D000328:Adult; D001552:Benzazepines / Q000008:administration & dosage / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D023801:Directly Observed Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008691:Methadone / Q000008:administration & dosage / Q000627:therapeutic use*; D009519:New York City; D009293:Opioid-Related Disorders / Q000453:epidemiology / Q000534:rehabilitation*; D010865:Pilot Projects; D011810:Quinoxalines / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D012646:Self Administration; D012907:Smoking / Q000453:epidemiology; D016540:Smoking Cessation / Q000379:methods*; D016320:Substance Abuse Treatment Centers; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D011810:Quinoxalines; D008691:Methadone; D000068580:Varenicline