Rapid Communication| Volume 31, ISSUE 9, P1957-1965, September 2009

Prediction of abstinence at 10 weeks based on smoking status at 2 weeks during a quit attempt: Secondary analysis of two parallel, 10-week, randomized, double-blind, placebo-controlled clinical trials of 21-mg nicotine patch in adult smokers

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      Background: Smoking cessation outcomes are calculated as the probability of abstinence at follow-up among all enrolled smokers, but it is also useful to estimate the probability of success for those who experienced success or failure at earlier time points.
      Objectives: The primary aims were to estimate the probability of maintaining abstinence through week 10 among subjects who were abstinent at week 2, and to assess the effect of active treatment with a nicotine patch. We also examined outcomes at week 6 and, among subjects who smoked during the first 2 weeks of treatment, the probability of reestablishing abstinence later, as well as the effect of active treatment on this outcome.
      Methods: We analyzed pooled data from 2 previously published, parallel, double-blind studies in which subjects were initially randomized to receive an active nicotine patch (starting at 21 mg) or a placebo patch. Subjects randomized to active treatment followed a double-blind step-down dosing regimen: 24-h/21-mg patches for the first 6 weeks of treatment, followed by 14- and 7-mg patches for successive 2-week periods. Biochemically verified abstinence (exhaled carbon monoxide ≤8 ppm) was assessed during laboratory visits.
      Results: Most subjects were white (94.8%) and female (61.6%), with a mean (SD) age of 43.1 (10.2) years. Subjects had been smoking for a mean of 24.5 (10.2) years and smoked a mean of 30.6 (10.4) cigarettes per day. In both the nicotine (n = 249) and placebo (n = 253) groups, all subjects who were abstinent during the first 2 weeks had a high probability of maintaining abstinence through week 10, but subjects treated with the active patch were significantly more likely to remain abstinent (active: 79.8% [67/84], placebo: 52.6% [20/38]; relative risk [RR] = 1.52 [95% CI, 1.10–2.09]). Also, at week 6, subjects receiving active treatment had a greater chance of remaining abstinent (active: 94.3% [82/87], placebo: 78.0% [32/41]; RR = 1.21 [95% CI, 1.02–1.43]). To assess the effect of treatment on recovery from smoking lapses, we examined the probability of abstinence during week 10 among subjects who smoked during the first 2 weeks of treatment. Among them, treatment was associated with a greater probability of later success: 31.4% (50/159) of those treated with the active patch and 12.5% (26/208) of those receiving placebo were abstinent at week 10 (RR = 2.52 [95% CI, 1.64–3.85]). Similar results were observed at week 6 (49.4% [80/162] vs 21.2% [45/212]; RR = 2.33 [95% CI, 1.72–3.15]).
      Conclusions: More than two thirds (71.3%) of subjects who were abstinent 2 weeks into a quit attempt maintained that abstinence through the end of 10 weeks of treatment. Use of a nicotine patch was significantly associated with maintaining abstinence and with recovering abstinence after an early lapse.

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        • Centers for Disease Control and Prevention (CDC)
        Annual smoking-attributable mortality, years of potential life lost, and productivity losses—United States, 1997–2001.
        MMWR Morb Mortal Wkly Rep. 2005; 54: 625-628
        • US Department of Health and Human Services
        The Health Consequences of Smoking: What It Means to You. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Washington, DC2004
        • Jha P
        • Chaloupka FJ
        Curbing the Epidemic: Governments and the Economics of Tobacco Control. World Bank, Washington, DC1999
        • Fiore MC
        • Jaén CR
        • Baker TB
        • et al.
        Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. US Dept of Health and Human Services, Public Health Service, Rockville, Md2008
        • Stead LF
        • Perera R
        • Bullen C
        • et al.
        Nicotine replacement therapy for smoking cessation.
        Cochrane Database Syst Rev. 2008; 1: CD000146
        • Shiffman S
        • Scharf DM
        • Shadel WG
        • et al.
        Analyzing milestones in smoking cessation: Illustration in a nicotine patch trial in adult smokers.
        J Consult Clin Psychol. 2006; 74: 276-285
        • Wileyto P
        • Patterson F
        • Niaura R
        • et al.
        Do small lapses predict relapse to smoking behavior under bupropion treatment?.
        Nicotine Tob Res. 2004; 6: 357-366
        • Durcan MJ
        • Johnston JA
        • White J
        • et al.
        Bupropion SR for relapse prevention: A “slips-allowed” analysis.
        Am J Health Behav. 2004; 28: 456-463
        • Bansal MA
        • Cummings KM
        • Hyland A
        • Giovino GA
        Stopsmoking medications: Who uses them, who misuses them, and who is misinformed about them?.
        Nicotine Tob Res. 2004; 6: S303-S310
        • Etter JF
        • Perneger TV
        Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public.
        Clin Pharmacol Ther. 2001; 69: 175-183
        • Shiffman S
        • Ferguson SG
        • Rohay J
        • Gitchell JG
        Perceived safety and efficacy of nicotine replacement therapies among US smokers and ex-smokers: Relationship with use and compliance.
        Addiction. 2008; 103: 1371-1378
        • Hughes JR
        • Gulliver SB
        • Fenwick JW
        • et al.
        Smoking cessation among self-quitters.
        Health Psychol. 1992; 11: 331-334
        • Hughes JR
        • Keely J
        • Naud S
        Shape of the relapse curve and long-term abstinence among untreated smokers.
        Addiction. 2004; 99: 29-38
        • Tønnesen P
        • Paoletti P
        • Gustavsson G
        • et al.
        • Collaborative European Anti-Smoking Evaluation, European Respiratory Society
        Higher dosage nicotine patches increase one-year smoking cessation rates: Results from the European CEASE trial.
        Eur Respir J. 1999; 13: 238-246
      1. Marlatt GA Gordon JR Relapse Prevention: Maintenance Strategies in the Treatment of Addictive Behaviors. Guilford Press, New York, NY1985
        • Kenford SL
        • Fiore MC
        • Jorenby DE
        • et al.
        Predicting smoking cessation. Who will quit with and without the nicotine patch.
        JAMA. 1994; 271: 589-594
        • Transdermal Nicotine Study Group
        Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials.
        JAMA. 1991; 266: 3133-3138
        • Davies HT
        • Crombie IK
        • Tavakoli M
        When can odds ratios mislead?.
        BMJ. 1998; 316: 989-991
        • Fagerström KO
        Measuring degree of physical dependence to tobacco smoking with reference to individualization of treatment.
        Addict Behav. 1978; 3: 235-241
        • Shiffman S
        • Paton SM
        Individual differences in smoking: Gender and nicotine addiction.
        Nicotine Tob Res. 1999; 1: S153-S157
        • Shiffman S
        • Paton SM
        Individual differences in smoking: Gender and nicotine addiction.
        Nicotine Tob Res. 1999; 1: S165-S166
        • Shiffman S
        • Sweeney CT
        • Ferguson SG
        • et al.
        Relationship between adherence to daily nicotine patch use and treatment efficacy: Secondary analysis of a 10-week randomized, double-blind, placebo-controlled clinical trial simulating over-thecounter use in adult smokers.
        Clin Ther. 2008; 30: 1852-1858
        • GlaxoSmithKline Consumer Healthcare
        Nicorette users guide.
        (Accessed June 6, 2009)
        • Joseph AM
        • Norman SM
        • Ferry LH
        • et al.
        The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease [published correction appears in N Engl J Med. 1996;356:2554].
        N Engl J Med. 1996; 335: 1792-1798
        • Fagerström KO
        • Hughes JR
        Nicotine concentrations with concurrent use of cigarettes and nicotine replacement: A review.
        Nicotine Tob Res. 2002; 4: S73-S79
      2. Requesting expansion of availability of nicotine replacement therapy to consumers who use tobacco.
        (Docket ID: FDA-2008-P-0116. Accessed August 21, 2009)
        • Shiffman S
        • Brockwell SE
        • Pillitteri JL
        • Gitchell JG
        Use of smokingcessation treatments in the United States.
        Am J Prev Med. 2008; 34: 102-111