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Articles   |    
Adapting Smoking Cessation Treatment According to Initial Response to Precessation Nicotine Patch
Jed E. Rose, Ph.D.; Frédérique M. Behm, C.R.A.
Am J Psychiatry 2013;170:860-867. doi:10.1176/appi.ajp.2013.12070919
View Author and Article Information

Dr. Rose has served as a consultant for Targacept and Philip Morris USA and has a patent purchase agreement with Philip Morris International. Both authors have received research funding from Philip Morris USA.

Supported by a grant to Duke University from Philip Morris USA. Nicotine patches were donated by GlaxoSmithKline. The companies had no role in the planning or execution of the study, data analysis, or publication of results.

ClinicalTrials.gov identifier: NCT00894166.

From the Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, N.C.

Address correspondence to Dr. Rose (jed.rose@duke.edu).

Copyright © 2013 by the American Psychiatric Association

Received July 14, 2012; Revised November 19, 2012; Accepted January 14, 2013.

Abstract

Objective  The authors evaluated an adaptive smoking cessation treatment strategy in which nicotine patch treatment was initiated before a quit date, and then, depending on initial therapeutic response, either the nicotine patch was continued or alternative pharmacotherapies were provided.

Method  The study was a double-blind, parallel-arm adaptive treatment trial. A total of 606 cigarette smokers started open-label nicotine patch treatment 2 weeks before the quit date. Those whose ad lib smoking did not decrease by >50% after 1 week were randomly assigned to one of three double-blind treatments: nicotine patch alone (control condition); “rescue” treatment with bupropion augmentation of the patch; or rescue treatment with varenicline alone. Participants whose precessation smoking decreased >50% but who lapsed after the quit date were also randomly assigned to the two rescue treatments or to nicotine patch alone. Logistic regression analyses compared each rescue treatment against the control condition in terms of abstinence at the end of treatment (weeks 8–11) and at 6 months.

Results  Smokers who did not respond adequately to precessation nicotine patch benefited from bupropion augmentation; abstinence rates at end of treatment were 16% with nicotine patch alone and 28% with bupropion augmentation (odds ratio=2.04, 95% CI=1.03–4.01). Switching to varenicline produced less robust effects, but point abstinence at 6 months was 6.6% with the patch alone and 16.5% with a switch to varenicline (odds ratio=2.80, 95% CI=1.11–7.06). Postquit adaptive changes in treatment had no significant effects on any abstinence outcome.

Conclusions  It is possible to rescue a significant portion of smokers who would have failed to achieve abstinence if left on nicotine patch alone by identifying these smokers before their quit date and implementing adaptive changes in treatment.

Abstract Teaser
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FIGURE 1. CONSORT Diagrams Depicting Participant Recruitment, Eligibility Assessment, Allocation to Treatment Conditions, and Disposition in a Study of Adapting Smoking Cessation Treatmenta

a In phase 1, cigarette smokers received precessation nicotine patch treatment, and those whose ad lib smoking did not decrease by >50% after 1 week were randomly assigned to remain on nicotine patch treatment, switch to varenicline, or augment nicotine patch with bupropion. In phase 2, participants whose precessation smoking decreased >50% but who lapsed after the quit date were also randomly assigned to the two rescue treatments or to nicotine patch alone.

FIGURE 2. Relationship of Initial Reduction of Ad Lib Smoking 1 Week Before Quit Date and 4-Week Continuous Smoking Abstinence at Week 11 in a Study of Adapting Smoking Cessation Treatmenta

a For smokers receiving nicotine patch treatment, the graphs show the relationship between 4-week continuous smoking abstinence and two measures of initial reduction of ad lib smoking 1 week before the quit date.

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TABLE 1.Baseline Participant Characteristics for Phase 1 and Phase 2 in a Study of Adapting Smoking Cessation Treatmenta
Table Footer Note

a In phase 1, participants whose smoking did not decrease by >50% after 1 week of a 2-week precessation period of open-label nicotine patch treatment were randomly assigned to one of the three double-blind conditions; participants whose smoking did decrease by >50% remained on open-label nicotine patch until phase 2. In phase 2, participants who lapsed into smoking during the first week after the quit date were randomly assigned to one of the three double-blind conditions; those who did not lapse remained on open-label nicotine patch.

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TABLE 2.Abstinence Rates (%) for Participants in Phase 1 and Phase 2 in a Study of Adapting Smoking Cessation Treatment
Table Footer Note

a Significant difference compared with randomized nicotine patch condition within each phase, p<0.05.

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1.
Of the currently FDA-approved treatments for smoking cessation, which carry “black box” warnings?
2.
Smokers wearing nicotine patches have the highest abstinence rate after the quit date if their smoking before the quit date shows the following:
3.
For smokers who do not decrease their smoking on nicotine patch by more than 50% before the quit date, switching to which of the following medications increases abstinence rate at the end of treatment (weeks 8–11 after the quit date)?:
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