Abstract
Objective and rationale
Smoking lapses represent an important juncture between smoking cessation and relapse. Nicotine replacement therapy (NRT) has been shown to decrease the risk of progression from lapse to relapse. We hypothesized that this effect might be mediated via decreases in reinforcement from smoking lapses.
Method
We assessed 169 subjects who lapsed during treatment in a double-blind placebo-controlled study of high-dose (35 mg) nicotine patch. Following their first lapse, using an electronic diary, subjects recorded the amount they smoked, and rated the pleasantness and satisfaction (“hedonic rating”) and the aversiveness of smoking. Subjects were then followed and assessed for further lapses and relapses.
Results
Subjects who smoked more during the first lapse had greater risk of progression [second lapse: hazard ratio (HR)=1.16, confidence interval (CI)=1.01–1.32; relapse: HR=1.22, CI=0.97–1.54]. Subjects with higher hedonic ratings of the first lapse also had a greater risk of progression to the second lapse (HR=1.08, CI=1.02–1.14) and to relapse (HR=1.26, CI=1.11–1.41). Aversive ratings had no bearing on progression. As expected, active treatment reduced the risk of both a second lapse (HR=0.54, CI=0.39–0.78) and a relapse (HR=0.22, CI=0.11–0.45). Importantly, however, NRT had no effect on hedonic ratings, amount smoked during the first lapse, or aversive ratings.
Conclusions
Hedonic response to an initial lapse predicted progression to relapse, but this did not mediate the effect of NRT on progression.
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Notes
Because many second lapses (27.8%) occurred on the same day as the first lapse, we also analyzed time to second lapse using hours as the unit of analysis. As the results were largely the same, we have not presented these analyses.
As less than half of the sample reached the relapse end point, the median value presented underestimated the true median for all subjects who would eventually relapse.
When considering the comparison between baseline ratings and lapse hedonic ratings, it should be noted that the two “assessments” were not strictly identical. Firstly, the smoking “situation” was different—whereas lapse assessments were likely colored by feelings of guilt and disappointment, it was unlikely that such feelings were present during baseline smoking. Additionally, baseline assessment could have been performed up to 30 min after finishing the cigarette being rated and, hence, was subjected to a greater degree of memory “bias.” Nevertheless, we feel that the comparison was still informative.
In addition, the effect of patch, as noted in Levin et al. (1994), was found in hedonic ratings on weeks 2 and 3 of treatment, not during the first week of treatment (when most of our first-lapse episodes were obtained). To test whether our findings might be affected by differential reactions to early (week 1) vs later lapses, we divided our sample into lapses in week 1 and later. There was no indication of an effect of time: the effects were very nearly identical and the time × treatment interaction was nonsignificant (p>0.90).
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Acknowledgements
This research was supported by a grant (DA 06084) from the National Institute on Drug Abuse to Saul Shiffman. We are grateful to GlaxoSmithKline Consumer Healthcare (GSKCH) for providing nicotine and placebo patches for the study (GSKCH did not otherwise participate in the study or in the paper).
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Saul Shiffman and Stuart Ferguson consult exclusively for GlaxoSmithKline Consumer Healthcare on matters relating to existing smoking cessation products. Dr. Shiffman also has an interest in a new smoking cessation product and is a founder of invivodata, which provides electronic diaries for clinical trials.
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Shiffman, S., Ferguson, S.G. & Gwaltney, C.J. Immediate hedonic response to smoking lapses: relationship to smoking relapse, and effects of nicotine replacement therapy. Psychopharmacology 184, 608–618 (2006). https://doi.org/10.1007/s00213-005-0175-4
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DOI: https://doi.org/10.1007/s00213-005-0175-4