title: Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial.
abstract: BACKGROUND
  This study evaluated the effect of varenicline in combination with counseling to assist long-term nicotine replacement therapy (NRT) users to quit NRT.
  
  
  METHODS
  This was a double-blind, placebo-controlled, randomized trial of varenicline or placebo for 12 weeks, with 52-week follow-up, performed in 1 hospital-based smoking cessation specialist clinic. At the first visit, 139 ex-smokers and long-term NRT users were allocated to treatment according to a computer-generated list with random numbers. Visits were scheduled at Weeks 0, 2, 4, 6, 9, 12, and 52. At each visit, nurse-led counseling was delivered, carbon monoxide in expired air, plasma cotinine, and body weight were assessed, and subjects were asked about craving, nausea, and dreams. The primary outcome was 12-week point prevalence quit rate (PPR) of nicotine replacement therapy use.
  
  
  RESULTS
  At all time points, the PPR was superior for varenicline versus placebo, although the difference was only statistically significant at 12 and 36 weeks. The PPR was 64.3% (varenicline) versus 40.6% (placebo) at 12 weeks (p = .006), and 42.9% (varenicline) versus 36.2% (placebo) at 52 weeks (NS). The continuous abstinence rate from Week 9 to Week 12 was 48.6 % (varenicline) versus 30.4 % (placebo) (p = .03). Withdrawal symptoms were statistically significantly lower in the varenicline group than the placebo group.
  
  
  CONCLUSIONS
  Varenicline for 12 weeks combined with supportive visits was superior to placebo to get long-term NRT users to quit NRT. A larger study is needed to evaluate long-term efficacy.
authors.affiliation: Department of Pulmonary Medicine, Gentofte Hospital, Copenhagen, Denmark. philipt@dadlnet.dk
authors.forename: Philip
authors.initials: P
authors.lastname: Tønnesen
authors.forename: Kim
authors.initials: K
authors.lastname: Mikkelsen
mesh_terms: D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D018733:Nicotinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D016540:Smoking Cessation; D013375:Substance Withdrawal Syndrome; D011795:Surveys and Questionnaires; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018733:Nicotinic Antagonists; D010919:Placebos; D011810:Quinoxalines; D009538:Nicotine; D000068580:Varenicline