title: A pilot clinical trial of varenicline for smoking cessation in black smokers.
abstract: BACKGROUND
  Varenicline, a first-line non-nicotine medication, has not been evaluated in Black smokers, and limited attention has been paid to pharmacotherapy adherence in smoking cessation trials. This pilot study estimated quit rates for Black smokers treated with varenicline and tested a behavioral intervention to aid varenicline adherence.
  
  
  METHODS
  Seventy-two Black smokers (>10 cigarettes per day; cpd) were randomly assigned to adherence support (AS; n = 36) or standard care (n = 36). All participants received 3 months of varenicline and a single counseling session focused on making a quit plan. AS participants received 5 additional counseling sessions to encourage medication use. Outcome measures included salivary cotinine, and carbon monoxide confirmed smoking abstinence, reductions in self-reported cpd, and pill counts of varenicline adherence at Months 1, 2, and 3.
  
  
  RESULTS
  Sixty-one participants (84.7%) completed follow-up at Month 3. Participants were female (62.5%), 46.8 years of age, and smoked 16.3 cpd. No treatment group differences were found on the smoking or adherence outcome measures (p > .05). Collapsing across treatment, varenicline adherence was adequate (86.1%), yet despite a reduction of 12.2 (6.5) cpd from baseline to Month 3 (p < 0.001), only 23.6% were confirmed quit at Month 3. Participants who were quit at Month 3 had higher varenicline adherence rates (95.8%) than those who continued to smoke (80.8%, p ≤ .05).
  
  
  CONCLUSIONS
  Studies are needed to examine the efficacy of varenicline among Black smokers. Interventions to facilitate adherence to pharmacotherapy warrant further attention as adherence is linked to improved tobacco abstinence.
authors.affiliation: Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS 66160, USA. nnollen@kumc.edu
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Nollen
authors.forename: Lisa Sanderson
authors.initials: LS
authors.lastname: Cox
authors.forename: Niaman
authors.initials: N
authors.lastname: Nazir
authors.forename: Edward F
authors.initials: EF
authors.lastname: Ellerbeck
authors.forename: Ashli
authors.initials: A
authors.lastname: Owen
authors.forename: Sydni
authors.initials: S
authors.lastname: Pankey
authors.forename: Nia
authors.initials: N
authors.lastname: Thompson
authors.forename: Jasjit S
authors.initials: JS
authors.lastname: Ahluwalia
mesh_terms: D000328:Adult; D001741:Black or African American; D001521:Behavior Therapy; D001552:Benzazepines / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D003376:Counseling / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage*; D010865:Pilot Projects; D011810:Quinoxalines / Q000008:administration & dosage*; D016540:Smoking Cessation / Q000208:ethnology / Q000379:methods*; D014029:Tobacco Use Disorder / Q000188:drug therapy* / Q000208:ethnology; D014481:United States; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline