title: Analyzing milestones in smoking cessation: illustration in a nicotine patch trial in adult smokers.
abstract: Tests of addiction treatments seldom reveal where treatment exercises its effect (i.e., promoting initial abstinence, preventing lapses, and/or impeding progression from lapse to relapse). The authors illustrate analyses distinguishing effects on these milestones in a randomized trial of high-dose nicotine patch (35 mg; n = 188) versus placebo (n = 136) in adult smokers, who used electronic diaries to monitor smoking in real time during 5 weeks of treatment. High-dose patch promoted initial abstinence (hazard ratio [HR] = 1.3) and decreased the risk of lapsing among those who achieved abstinence (HR = 1.6). The biggest effect of treatment was to prevent progression to relapse among those who had lapsed (HR = 7.1). Analysis of effects by milestones may enhance understanding of cessation treatments and their mechanisms of action.
authors.affiliation: Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15213, USA. shiffman@pitt.edu
authors.forename: Saul
authors.initials: S
authors.lastname: Shiffman
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Scharf
authors.forename: William G
authors.initials: WG
authors.lastname: Shadel
authors.forename: Chad J
authors.initials: CJ
authors.lastname: Gwaltney
authors.forename: Qianyu
authors.initials: Q
authors.lastname: Dang
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Paton
authors.forename: Duncan B
authors.initials: DB
authors.lastname: Clark
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation / Q000379:methods*
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine