Transdermal Nicotine Replacement (TNR) is the best current addictions medication, doubling smoking cessation rates compared to placebo. Yet, the mechanism underlying its effects is still uncertain. Moreover, TNR typically fails: 79% of TNR patients relapse, two-thirds while still receiving nicotine. We propose to examine the mechanisms for TNR's success -- and its failures. TNR is posited to prevent relapse by blunting unconditioned withdrawal and craving, particularly early in cessation. TNR's effect on craving -- and its inadequacy in preventing relapse -- is reflected in our finding that smokers on TNR often relapse in the complete absence of subjective craving. We hypothesize that when craving is blunted by TNR, other factors such as conditioned responses to smoking cues, intrusive thoughts about smoking, and behavioral habits become important causes of relapse. We propose to assess these factors in the first intensive study of how agonist therapy affects the relapse process. To avoid relying on retrospective recall, we have developed a novel method using palm-top computers to obtain near-real-time reports of events in subjects' natural environment. We have demonstrated the feasibility and validity of the method for studying relapse, and shown that both global self-reports of smoking patterns and later recall of initial relapse episodes are inaccurate. In an amended (scaled down) design, we will use this method to study relapse in 353 smokers randomized, double-blind, to high-dose nicotine replacement (35 mg for 3 weeks, 21 mg for 2 weeks) or placebo. We will over-sample African-Americans to achieve 33% representation. Subjects will monitor ad lib baseline smoking for 1 week. The Electronic Diary (ED) will assess situational and affective antecedents of smoking, which relate to idiosyncratic conditioned associations. After quitting, subjects self-monitor for 6 weeks, recording temptation and lapse episodes for 5 weeks of active TNR and 1 week after TNR. Throughout, the ED prompts subjects for randomly-scheduled base-rate assessments (4/day). Withdrawal and craving are monitored several times daily. Once daily, ED assesses withdrawal-related changes in cognitive performance, experience of intrusive thoughts, behavioral automatisms and smoking expectancies. Our analytic approach emphasizes random-effects regression methods that allow for multiple observations per subject. The models include nicotine dependence and time since cessation as important moderating variables. This is not a treatment efficacy study; our unique focus is on fine-grained analysis of the relapse process, and how it is affected by pharmacologic treatment with TNR. By revealing why and how TNR fails, the findings will assist in development of improved behavioral strategies to supplement TNR; the results may also be relevant to medications development (particularly agonist drugs) for other drug addictions.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA006084-09
Application #
2897804
Study Section
Human Development Research Subcommittee (NIDA)
Project Start
1990-06-01
Project End
2002-08-31
Budget Start
1999-09-01
Budget End
2002-08-31
Support Year
9
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Shiffman, Saul (2014) Conceptualizing analyses of ecological momentary assessment data. Nicotine Tob Res 16 Suppl 2:S76-87
Ferguson, Stuart G; Shiffman, Saul (2014) Effect of high-dose nicotine patch on craving and negative affect leading up to lapse episodes. Psychopharmacology (Berl) 231:2595-602
Rathbun, Stephen L; Song, Xiao; Neustifter, Benjamin et al. (2013) Survival Analysis with Time-Varying Covariates Measured at Random Times by Design. J R Stat Soc Ser C Appl Stat 62:419-434
Kirchner, Thomas R; Shiffman, Saul; Wileyto, E Paul (2012) Relapse dynamics during smoking cessation: recurrent abstinence violation effects and lapse-relapse progression. J Abnorm Psychol 121:187-97
Shiyko, Mariya P; Lanza, Stephanie T; Tan, Xianming et al. (2012) Using the time-varying effect model (TVEM) to examine dynamic associations between negative affect and self confidence on smoking urges: differences between successful quitters and relapsers. Prev Sci 13:288-99
Shiffman, Saul; Rathbun, Stephen L (2011) Point process analyses of variations in smoking rate by setting, mood, gender, and dependence. Psychol Addict Behav 25:501-10
Chandra, Siddharth; Scharf, Deborah; Shiffman, Saul (2011) Within-day temporal patterns of smoking, withdrawal symptoms, and craving. Drug Alcohol Depend 117:118-25
O'Connell, Kathleen A; Shiffman, Saul; Decarlo, Lawrence T (2011) Does extinction of responses to cigarette cues occur during smoking cessation? Addiction 106:410-7
Ferguson, Stuart G; Shiffman, Saul (2010) Effect of high-dose nicotine patch on the characteristics of lapse episodes. Health Psychol 29:358-66
Dunbar, Michael S; Scharf, Deborah; Kirchner, Thomas et al. (2010) Do smokers crave cigarettes in some smoking situations more than others? Situational correlates of craving when smoking. Nicotine Tob Res 12:226-34

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