Smoking Cessation Treatment: Helping Smokers Quit

1. Smoking Cessation Treatment:Helping Smokers Quit Saul Shiffman, Ph.D. Research Professor Psychology, Psychiatry, Pharmaceutical Sciences Consultant: GlaxoSmithKline Interest in developing pharmacotherapy

2. Role of Treatment • Quitting among current smoklesr key to achieving reduction in mortality in next 50 years • Public education and policy pressures unlikely to get all smokers to quit • Smoking is addictive, so many smokers have difficulty quitting • Treatment may be most needed by those most at risk for morbidity & mortality • Access to effective treatment may be regarded as a right

3. Smoking Relapse

4. Behavioral treatment Pharmacologic treatment

5. Evaluating Treatment Efficacy • Meta-analysis synthesis • Outcomes • Abstinence at 6 months + • Continuous or last 7 days • “Not even a puff” • Biochemically validated • Missing = failure • Research criteria stricter than public health criteria

6. Behavioral Treatment • Convergence on loose collection of cognitive-behavioral methods • Aim to provide tools and techniques for behavior change • e.g., avoiding triggering stimuli, planning rewards • Increasingly, differentiated by delivery modality

7. Person Face-to-face 1-on-1 Group Telephone Reactive Proactive Media Medium Print Internet Tailoring 1-size-fits-all Tailored Channels for Delivery of Behavioral Treatment

8. Effect by Treatment Modality Source: AHRQ analysis: 2000

9. Dose-Response Effect: Treatment Sessions Source: AHRQ analysis: 2000

10. “Alternative” Treatments Source: AHRQ analysis: 2000

11. Medications • Primarily aim to reduce craving and withdrawal, to make behavior change easier • Other mechanisms being explored, particularly reduced reward from smoking

13. Nicotine Replacement Therapy (NRT) • Transition smoker off smoking by temporarily replaceing “lost” nicotine with low-dose medicinal nicotine, to minimizew craving and withdrawal • Patch • Gum • Lozenge • Inhalator • Nasal Spray

14. Meta-Analysis of NRT RCTs

15. Innovations in NRTNot Approved in the US • Combinations • “Steady-state” patch + “as-needed” acute form • Incremental efficacy (OR = 1.9) • Pre-treatment • Use patch for 2-4 weeks before quitting • Incremental efficacy (OR = 2.2) • Reduce to Quit • Smokers interested in quitting gradually, use gum to reduce smoking over 8 weeks • Increases quit rate (OR = 2.7) • Reduce Until Ready to Quit • Smokers not interested in quitting use NRT to cut down over 6-9 months • Increases quit rate (OR= 1.6)

16. Is Behavioral Intervention Necessary for NRT to Work? • Myth: Medications / NRTs do not work unless accompanied by behavioral treatment • OTC NRTs demonstrated efficacy with NO formal behavioral treatment • Effects of behavioral treatment & medication are additive • Each works equally well without the other • The combination yields highest success rates

17. Non-Nicotine MedicationsPrescription Only • Bupropion • Zyban Wellbutrin • Atypical antidepressant • Effects not limited to depressed • Varenicline • Nicotine receptor partial agonist / antagonist • Nortriptyline • Tri-cyclic antidepressant • Tested in academic trials • Clonidine • Catapres • Antihypertensive, 2 agonist (reduces sympathetic tone) • Tested in academic trial

18. Effective Medications;Few Differences Demonstrated NA Rx Products vary in number, age, & type of study; Studies vary in dosing; populations, assessments, behavioral intervention, & length of follow-up OTC Source: AHRQ analysis: 2000 + Shiffman et al 2003 + Wu et al 2006

19. On the Horizon • Many novel CNS drugs and novel applications of existing CNS drugs • Nicotine vaccine • Sequester nicotine in periphery, to prevent entry into brain, block reinforcement • Clinical utility unknown

20. Public Health Impact Public Health Impact = Efficacy (% quit) X Utilization (# using method)

21. Utilization of Treatments • A treatment that is not used has no effect on quitting or public health

22. Utilization of Behavioral Treatments Any behavioral = 8.8% Shiffman et al, under review, based on CPS, 2003

23. Utilization of Medications Any medication = 32.2% ------OTC------ ------Rx------ Shiffman et al, under review, based on CPS, 2003

24. Impact of OTC Availability on Utilization of NRT Medications Estimated Assisted Quit Attempts(in thousands) Burton et al, MMWR, 2000 + additional GSK data

25. Use of Treatment DO NOT CITE WITHOUT PERMISSION Shiffman et al, under review, based on CPS, 2003

26. Treatment Use Lower in Minority Populations DO NOT CITE WITHOUT PERMISSION Ethnic-group differences persist when controlling for income, education Shiffman et al, under review, based on CPS, 2003

27. Summary • Unaided cessation yields 3% success rates • Variety of behavioral treatments & medications available • Modest absolute efficacy, good relative efficacy • New treatments over the horizon, but no breakthroughs • Low utilization, therefore modest public health impact • Short and medium-term gains most likely to come from increased utilization / reach

29. Utilization of Treatments • A treatment that is not used adequately has less effect on quitting or public health • Most users don’t use enough medication for long enough to reap full benefit

30. Compliance with Medication • Duration • Longer use = increased efficacy • NRT recommended for 10-12 weeks • Typical use < 4 weeks • Dosing • More use = increased efficacy • Gum & lozenges recommended 9+ pieces/day • Typical use 4-6 pieces / day