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

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Smoking Cessation Treatment:Helping Smokers Quit

Saul Shiffman, Ph.D.

Research Professor

Psychology, Psychiatry, Pharmaceutical Sciences

Consultant: GlaxoSmithKline

Interest in developing pharmacotherapy


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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



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Behavioral treatment

Pharmacologic treatment


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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


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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


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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


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Effect by Treatment Modality

Source: AHRQ analysis: 2000


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Dose-Response Effect: Treatment Sessions

Source: AHRQ analysis: 2000


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“Alternative” Treatments

Source: AHRQ analysis: 2000


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Medications

  • Primarily aim to reduce craving and withdrawal, to make behavior change easier

    • Other mechanisms being explored, particularly reduced reward from smoking


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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



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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)


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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


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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


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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


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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


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Public Health Impact

Public Health Impact

=

Efficacy (% quit)

X

Utilization (# using method)


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Utilization of Treatments

  • A treatment that is not used has no effect on quitting or public health


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Utilization of Behavioral Treatments

Any behavioral = 8.8%

Shiffman et al, under review, based on CPS, 2003


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Utilization of Medications

Any medication = 32.2%

------OTC------

------Rx------

Shiffman et al, under review, based on CPS, 2003


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Impact of OTC Availability on Utilization of NRT Medications

Estimated Assisted Quit Attempts(in thousands)

Burton et al, MMWR, 2000 + additional GSK data


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Use of Treatment

DO NOT CITE WITHOUT PERMISSION

Shiffman et al, under review, based on CPS, 2003


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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


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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


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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


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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


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