1. Using EMA Data to Examine Negative Affect and Craving During a Quit Attempt Megan E. Piper, Ph.D. Assistant Professor Center for Tobacco Research & Intervention Department of Medicine UW School of Medicine and Public Health

2. Research Aims To examine the patterns of negative affect and craving pre- and post-quit – Withdrawal dimensions include average intensity, variability/volatility and trajectory (Piasecki et al. 1998; Piasecki et al. 2003a; Piasecki et al. 2000) To examine how temptation events influence negative affect and craving – Deprivation can enhance cue reactivity, which may influence smoking motivation (Acri and Grunberg 1992; Gloria et al., 2009; McCarthy et al. 2006; McClernon et al., 2009; Shiffman et al. 2006; Shiffman et al. 1996; Spiga et al. 1994; cf Perkins 2009a)

3. Research Aims To examine how withdrawal parameters and reactivity to temptation events are related to short-term cessation success

4. Recruitment and inclusion/ exclusion criteria Recruited in Madison and Milwaukee, WI – TV, radio and newspaper advertisements, community flyers – Earned media Inclusion criteria: – Smoking ≥ 10 cigs/day for the past 6 months – Motivated to quit smoking Exclusion criteria: – Medications contraindicated for bupropion – Consuming ≥ 6 alcoholic beverages 6-7 days/week – Self-reported history of psychosis or bipolar disorder

5. CONSORT figure N = 8526 Expressed interest n = 1418 Declined n = 2010 Unreachable n = 2027 Failed screen n = 3153 Passed phone screen n = 1331 Withdrew n = 1504 Randomized n = 318 Excluded Lozenge n = 260 Patch n = 261 Bupropion SR n = 266 Patch + Lozenge n = 267 Bupropion SR + Lozenge n = 261 Placebo n = 189

6. Study participants N = 1504 (58.2% women) Ethnicity – 1258 (83.9%) White – 204 (13.6%) African-American – 42 (2.8%) parents of Hispanic origin 21.9% had a 4-year college degree Mean age = 44.67 (SD = 11.08) Mean cigs. smoked/day = 21.43 (SD = 8.93) Mean number of quit attempts = 5.72 (SD = 9.65)

7. Weeks TQD Year 3Year 2Year 16 mo. V9V10V11V12 Information Session Orientation V8V7V6V5V4 V3 - Randomization V2V1 1248-2-3-4 BaselineTreatment*Follow-up Study timeline *Counseling and medication EMA period

8. EMA Protocol Palmtop computers 4 prompts per day – Waking – 2 random during the day (separated by at least 1 hour) – Prior to going to bed 2 weeks pre-quit and 2 weeks post-quit – Analyzed data 10 days pre-quit and 10 days post- quit

9. EMA Questions – Every prompt In the last 15 minutes rate: – Negative and positive affect – Craving – Hunger – Difficulty Concentrating – Restlessness Smoking since last prompt

10. EMA Questions – Every prompt Self-efficacy Cessation fatigue Motivation to work hard to quit Positive smoking expectancies Temptation events and coping

11. EMA Questions – Evening Prompt Cessation medication usage Alcohol and caffeine use Menstruation Stressor occurrence and coping Pleasurable daily activities

13. EMA Compliance Of the total 80 assessments (4 times/day for 20 days): – Mean prompts completed = 50.9 – Median prompts completed = 53 Missing data was significantly positively related to 8-week relapse – OR = 1.03, p <.001 When analyses controlled for missing data, the results were similar

14. Mean Negative Affect

15. Mean Daily Craving

16. Negative Affect for 4 Participants

17. Craving for 4 Participants

18. Temptation “Since your last report, did anything happen that made you want to smoke?” Pre-quit (18.9%) vs. Post-quit (19.5%) – Χ 2 = 3.69, p =.055 Examine craving and negative affect with a general linear model looking at pre-quit vs. post-quit and temptation event vs. no temptation event

19. Temptation and Negative Affect F(1, 63340) = 7.85 p =.005

20. Temptation and Craving F(1, 63340) = 105.17 p <.001

21. Withdrawal and Cessation 8-week CO-confirmed point-prevalence abstinence Controlling for treatment and post-quit smoking – Treatment: 0 = placebo, 1 = monotherapy, 2 = combination therapy – Smoking: 0 = no smoking, 1 = < 1 cig/day, 2 = 1 or more cig/day

22. Withdrawal and Cessation Change (post-pre) in: – Mean level – Frequency of extreme reports – Variability (SD) – Mean level when temptation event reported – Mean level when no temptation event reported

23. Univariate Prediction of 8-week Abstinence – Negative Affect Withdrawal measureWaldp-valueOROR 95% CI Change in negative affect mean 8.73.003.82.72,.94 Change in negative affect SD2.83.09.83.67, 1.03 Change in percent of negative affect reports greater than 4 1.81.18.99.97, 1.01 Change in negative affect mean when faced with a temptation event.92.34.95.86, 1.05 Change in negative affect mean when not faced with a temptation event 4.77.03.85.74,.98

24. Univariate Prediction of 8-week Abstinence – Craving Withdrawal measureWaldp-valueOROR 95% CI Change in craving mean19.58<.001.89.84,.93 Change in percent of craving reports greater than 7 9.41.002.99.988,.997 Change in craving mean when faced with a temptation event 6.19.01.93.88,.985 Change in craving mean when not faced with a temptation event 14.38<.001.90.85,.95

25. Best-Fitting Multivariate Model to Predict 8-week Abstinence Withdrawal measureWaldp-valueOROR 95% CI Change in craving mean 6.15.01.90.83,.98 Change in negative affect mean 12.92<.001.62.48,.80 Change in negative affect mean when faced with a temptation event 5.43.021.181.03, 1.37

26. Addressing Smoking During EMA Considerable post-quit smoking is required to reduce withdrawal symptoms (Piasecki et al., 2003) 80% reported smoking <1 cig/day in the first 10 days – 34% reported no smoking Results were consistent when removed participants who reported smoking 5 or more cigs/day on average for the 10 days post-quit (n = 47)

27. Conclusions Relative to negative affect, craving reports are more intense, on average, more variable and are more likely to be extreme – 20% of craving reports were greater than 1 SD – 1.6% of negative affect reports were greater than 1 SD Craving returns to pre-quit levels by 10 days but negative affect does not

28. Conclusions Quitting results in reactivity (i.e., increased negative affect and craving) when confronted with temptation events Cessation success is related to: – Various withdrawal components: negative affect, craving and reactivity to temptation events – Various withdrawal parameters: mean level, extreme reports

29. Acknowledgements Piper, M. E., Schlam, T. R., Cook, J. W., Sheffer, M. A., Smith, S. S., Loh, W.-Y., Bolt, D. M., Kim, S.-Y., Kaye, J. T., Hefner, K. R., & Baker, T. B. (2011). Tobacco withdrawal components and their relations with cessation success. Psychopharmacology 216, 569-578. PMCID: PMC3139774 Staff and students at the Center for Tobacco Research and Intervention NIH grants: P50 DA019706 (NIDA), M01 RR03186 (General Clinical Research Centers Program), 1UL1RR025011 from the Clinical and Translational Science Award (CTSA; Piper), K08DA021311 (Cook), 1K05CA139871 (Baker) and U. S. Army Research Office grant W911NF ‑ 09 ‑ 1 ‑ 0205 (Loh)

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