Increasing Cessation Rates with NRT

1. Increasing Cessation Rates with NRT Gay Sutherland Research & Consultant Clinical Psychologist Tobacco Research Unit, Institute of Psychiatry, King’s College London & Specialist Smoking Cessation Clinic South London & Maudsley NHS Foundation Trust ENQ Conference 29th – 30th Jan 2009 (Paris)

2. NRT Re-Cap: • Doubles quit rates of both brief and intensive interventions • Reduces severity of withdrawal symptoms • Delays weight gain • Reduces relapse • Gives ~50% nicotine replacement • Very safe (if used by smokers!)

3. Efficacy (Odds Ratios) of NRTCochrane 2008 Gum 1.7 Patch 1.7 Inhaler 2.1 Nasal Spray 2.5 Microtab/Lozenge 2.1

4. Consistency of NRT Efficacy(Cochrane 2008) 111 RCTs 22,732 smokers 106 of 111 showed positive results

5. NRT Re-Cap: • Reduces severity of withdrawal symptoms and craving to smoke

6. Dose of NRT needs to be in this range

7. NRT Re-Cap: • Doubles quit rates of both brief and intensive interventions • Reduces severity of withdrawal • Delays weight gain • Reduces relapse • Gives ~50% nicotine replacement • Very safe (if used by smokers!)

8. But nothing like a cigarette!

10. Common False Beliefs About NRT Cummings (2004)

11. Common False Beliefs About NRT We Need to Address What % think NRT does not increase quit rates? 41% Cummings (2004)

12. Common False Beliefs About NRT We Need to Address What % think risk of addiction with the patch is as high or higher than for cigarettes? 54% Cummings (2004)

13. Common False Beliefs About NRT We Need to Address What % think risk of heart attacks from the patch is as high or higher than for cigarettes? 65% Cummings (2004)

14. Common False Beliefs About NRT We Need to Address What % think nicotine causes cancer? 67% Cummings (2004)

15. Public Perception of NRT • US national survey, 3,203 current and former smokers • 66% agreed that ‘NRT is just as harmful as cigarettes’ or were unsure if true • Less likely to use NRT and if used, used less and for shorter time • Public education needed – how to do it? Shiffman et al. 2008, Addiction 103, 1371-1378

16. NRT efficacy is harmed by: • Unrealistic expectations (‘magic cure’, waiting for the drug to ‘make me stop smoking’) • Insufficient and incorrect use (fear of nicotine, using only when desperate) • Lack of preparation for the fact that oral products in particular may take time to get used to

17. John Stapleton (2008) • Since NRT was introduced 30 years ago its full potential has remained underdeveloped and under-researched • Licence say: • Start using NRT on day smoking stops; • Use a limited dosage while not smoking • Stop using NRT if smoking resumes • Use for only 10–16 weeks, regardless of progress! Addiction (2008)

18. One Size Does Not Fit All!

19. Can we do better with NRT?

20. Better Ways of Using NRT • Pre-Treatment before Quit Day? • Combination NRT? • Use Higher Doses? • Use During a Lapse or “Slip”? Adapted from Hughes (2008) UKNSCC

21. Possible Rationale? • Improve efficacy by separating nicotine levels from smoking and thus extinguishing smoking reinforcement • Help smokers cut-down and increase their confidence in quitting • Might get smokers used to NRT

22. NRT Use Prior to Quitting • Meta-analysis of 4 studies • Pre-treatment with patches for 2 weeks (3 studies) or 4 weeks (1 study) • 6-months abstinence OR=2.2 • But: • 3 studies by the same author • 4-week pre-treatment was the only study with negative results Shiffman and Ferguson (2008) Addiction, 103,

23. Better Ways of Using NRT • Pre-Treatment before Quit Day? • Combination NRT? • Use Higher Doses? • Use During a Lapse or “Slip”? Adapted from Hughes (2008) UKNSCC

24. Rationale for Combination NRT? Patch gives steady levels of nicotine easily plus oral “top-ups” when needed Likely to lead to higher nicotine replacement levels

25. Cues or “Triggers” to Smoke Tea/Coffee Alcohol Concentration Boredom Stress Reward 35 30 25 20 15 10 5 0 Driving Telephone Social(peer pressure) (Time) Habit After a meal Daily Event

26. Central Role of Craving • “Background”craving: • Steady during the day • Internal - needs no environmental triggers • Gradually reduces in intensity over a few weeks • “Episodic”craving: • Occasional intense bursts • Triggered by environmental cues or mood • Decreases in frequency but NOT intensity for months • Caused by being in situations ex-smoker has not yet got “habituated” to Patch Faster Self-Dosed NRT

27. Combining 2 Different NRT’s • Usually patch + faster self-administered product • 7 trials included in Cochrane review show overall benefit (OR=1.42) Silagy et al. (Cochrane Library)

28. What time of day do people relapse? (%) Brandon et al 1986

29. NICE Endorses Combination Therapy ‘Consider offering a combination of nicotine patches and another form of NRT… to people who show a high level of dependence on nicotine or who have found single forms of NRT inadequate in the past.’ Feb 2008 This meeting is sponsored GlaxoSmithKline Consumer Healthcare [NCQ/CW/0608/005]

30. …Craving predicts who is most likely to relapse….

32. Essential to get good craving relief early on in the quit attempt

33. Quitting early matters! • Cease Trial: 25% of smokers abstinent in their 1st week stayed quit for 1 yr vs only 2.7% of those who smoked in 1st week • A Patch study of 1,686 smokers also found early quitting the strongest predictor of sustained abstinence • Of the 1st week quitters, 25% of those on NRT and 28% on placebo became long-term quitters vs only 4% (NRT) and 2% (placebo) if they smoked in the 1st week • Another study of 1,200 smokers found all but 1 of the 96 subjects who quit long-term, had quit during their 1st week

34. Better Ways of Using NRT • Use it for Longer? • Pre-Treatment before Quit Day? • Use Higher Doses? • Use During a Lapse or “Slip”? Adapted from Hughes (2008) UKNSCC

35. Higher Doses of NRT for Greater % Nicotine Replacement? European Respiratory Journal (1999)

36. European Multi-Centre CEASE Trial • RCT to see if higher dose and longer duration of use of 16hr daytime-only patches increase quit rates • 36 chest clinics in 17 countries • 3,575 smokers took part (>14 cigs per day) • Smokers randomized to 1 of 5 groups: • 25mg patch (15 + 10mg) for 22 wks - 15mg for 2 wks - 10mg for 2 wks • 25mg patch (15 + 10mg) for 8 wks - 15mg for 2 wks - 10mg for 2 wks -14 wks of placebo patches • 15mg patch + placebo for 22 wks - 10mg for 4 wks • 15mg patch + placebo for 8 wks - 10mg for 4 wks - 14 wks of placebo patches • 2 x placebo patches for 26 wks • Smokers also received behavioural support

37. High dose Standard dose Placebo

38. CEASE Trial Results • 1 yr sustained quit rates were: • High dose long duration = 15.4% • High dose standard duration = 15.9% • Standard dose long duration = 13.7% • Standard dose standard duration = 11.7% • Placebo = 9.9% • No sign. difference in quit rates between long and standard duration patch use • High dose patches increased long-term quit rates • But no advantage in using for longer than 8-12 weeks

39. Higher nicotine doses also gave better relief of tobacco withdrawal symptoms

41. CEASE Trial - Safety • Higher doses were well tolerated • Side-effects were mild and typical of NRT (eg skin irritation) • No unexpected or serious adverse events

42. Higher Doses or TailoringNRT (Cochrane 2008) Higher Doses of Patch: 7 trials = 1.2 (OR) Tailoring Dose to Blood Levels: 2 small trials both report improvement

43. The Implications? • A 25mg/16 hr patch will soon be launched in some European countries • Many clinicians are too cautious about dosing • SPCs for NRT usually have cut-offs based on cigs/day which are unduly conservative and not supported by the evidence

44. Better Ways of Using NRT • Use it for Longer? • Pre-Treatment before Quit Day? • Use Higher Doses? • Use During a Lapse or “Slip”? Adapted from Hughes (2008) UKNSCC

45. Importance of Continuing NRT During a Lapse or “Slip”(Shiffman 2006) Prevention of a lapse or slip to full relapse = 7.1

46. Lapse Recommendations • Keep using NRT! • Increase Dose of Patch • Increase Dose of Acute NRT • Add a 2nd NRT John Hughes 2008

47. Bottom Line • Max effort early on. Get good NRT dosing from the beginning • Be flexible - switch NRTs if smoker prefers • Use combinations • Use higher doses • Continue with NRT during lapses • Most important - keep re-treating “failures”!!!

48. John Hughes (2008 UKNSCC) • “Using NRT via guidelines is suboptimal treatment and should be discouraged” • “Allowing fear of complaints or lawsuits to prevent optimal care is unethical”